Diabetic Nephropathy
Conditions
Keywords
H.P. Acthar Gel, Acthar, diabetic nephropathy, proteinuria, nephrotic syndrome
Brief summary
This Phase 2A study is an adaptive design pilot study investigating the efficacy and safety of daily Acthar administration in diabetic patients with nephropathy and proteinuria. Patients with type 1 diabetes mellitus (T1DM) or T2DM who currently take insulin will be enrolled and randomized into 6 study groups and will be treated with either Acthar or Placebo for 36 weeks, followed by a 4 week dose taper, and a 12 week observation period. The study will compare three dose regimens of Acthar (8 U \[0.1 mL\], 16 U \[0.2 mL\], and 32 U \[0.4 mL\]) to equivalent volumes of Placebo to ensure the double-blind nature of the study. Insulin-requiring patients are being enrolled to aid compliance with the daily SC administration of study medication and to allow for ease of blood glucose control by adjustment of current insulin therapy in the event of glycemic excursions. Routine safety measures, including glycemic control, will be monitored throughout the study. The adaptive design component of the study allows for the re-assignment of the high dose group to the mid dose group if unacceptable toxicity is noted as per study protocol in the high dose group. Efficacy will be assessed by monitoring serum creatinine, calculated eGFR, and proteinuria (via urinary protein to creatinine ratio \[PCR\]). Serum cortisol concentration and additional biomarkers in blood and urine will also be monitored.
Interventions
H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups \[8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)\].
DRUGPlacebo
Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes.
Sponsors
Mallinckrodt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The 32U group was discontinued after 2 patients met pre-specified criteria related to tolerability and patients assigned to the 32U were re-assigned to the 16U group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(numbers 2, 3, 4, 5, 6, and 7 per protocol): * Body mass index ≤ 45 kg/m2 at screening. * Diagnosis of T1DM or T2DM, with HbA1c ≤ 9.0% at Visit 1A. Diagnosis of T2DM should have been made at \> 30 years of age (if diabetes developed at a younger age, C-peptide level may be obtained to confirmed the diagnosis). * Currently insulin-requiring * Patients on oral hypoglycemic therapy plus insulin are eligible provided that oral hypoglycemic agent(s) administered and the dosing regimen(s) of oral hypoglycemic therapy have been stable for ≥ 12 weeks prior to screening. No changes in oral hypoglycemic therapy should be planned or anticipated during the treatment period. * Renal Target Disease Requirements: * The average of two eGFR values collected during screening (Visits 1 and 1A) must be between 20-60 mL/min/1.73m2 (calculated using the abbreviated Modification of Diet in Renal Disease \[MDRD\] equation AND * Protein to creatinine ratio (PCR) ≥ 3.0 g/g OR total urine protein ≥ 3.0 g from the 24-hour urine collection returned at Visit 1A. * Antihypertensive Therapy: * Treatment with an ACEI and/or an ARB for at least 6 weeks prior to screening Visit 1A, with stable maintenance dose for ≥ 14 days prior to screening Visit 1A. No change in ACEI or ARB therapy should be planned or anticipated for the period of the study. * If treated with additional antihypertensive therapy(ies), duration of therapy ≥ 30 days prior to screening Visit 1A, with stable maintenance dose for ≥ 14 days prior to screening Visit 1A. * If the patient has documented intolerance to ACEI and/or ARB therapy (e.g. angioedema, hyperkalemia), they may be eligible for study entry, but the Medical Monitor must be consulted in these cases prior to randomization. * Mean systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg on ≥ 3 seated readings taken at least 5 minutes apart during the screening period at Visit 1A.
Exclusion criteria
(numbers 2, 3, 4, 5, 7, and 11 per protocol): * Therapies and/or Medications: * History of prior sensitivity to Acthar or other porcine protein products. * Chronic systemic corticosteroid use, defined as ≥ 20 mg of prednisone or equivalent systemic corticosteroid taken for more than 4 consecutive weeks within 6 months prior to randomization. Topical, inhaled, or intra-articular corticosteroids are allowed. * Planned treatment with live or live attenuated vaccines once enrolled in the study. * Previous treatment on a drug being investigated for the treatment of diabetic nephropathy within 6 months prior to randomization. * Contraindication to Acthar per Prescribing Information Section 4: scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction. * For the purpose of this study, history of peptic ulcer is defined as ≤ 6 months prior to Visit 1A. * Diabetes Target Disease Exceptions: * Severely uncontrolled diabetes mellitus as judged by the Principal Investigator * HbA1c \> 9% at screening Visit 1A. * Fasting serum glucose \> 230 mg/dL at BOTH screening Visits 1 and 1A. * History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 6 months of screening. * History of ocular laser photocoagulation therapy within 6 months of screening OR diabetic retinopathy, diabetic macular edema, or cataracts associated with impairment of visual acuity that will affect adherence with the dosing or administration of SC injections. * Patients unwilling to titrate insulin for blood glucose control if adjustment of hypoglycemic therapy is required during the study. * Renal Target Disease Exceptions: * History of clinical or renal biopsy evidence of non-diabetic renal disease * Patients requiring diagnostic or interventional procedure requiring an intravenous contrast agent must delay screening/randomization for at least 14 days * Tuberculosis: Any patient with a positive Interferon-gamma release assay, OR signs and symptoms concerning for active tuberculosis. * Cardiovascular: * History of congestive heart failure (NYHA Functional Class III-IV). * History of dilated cardiomyopathy with ejection fraction \< 40%. 1\. Exceptions require approval by the Medical Monitor. * Patient has had any of the following within 3 months of screening: 1. Unstable angina 2. Myocardial infarction 3. Coronary artery bypass graft or percutaneous transluminal coronary angioplasty 4. Transient ischemic attack or cerebrovascular accident 5. Unstable arrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12 | Visit 12 (Week 36) | Percent change in eGFR at Visit 12 (Week 36) compared to average baseline eGFR obtained during screening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in eGFR at Visit 17 | Visit 17 (Week 52) | Percent change in eGFR at Visit 17 (Week 52) compared to baseline eGFR obtained during screening |
| Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 12 (Week 36) and Visit 17 (Week 52) | — |
| Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) and Visit 17 (Week 52) | Proportion of patients with complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of \>50% from baseline, plus PCR≤2.5 g/g but \>0.5 g/g) of proteinuria at Visit 12 (Week 36) and/or at Visit 17 (Week 52) |
| Percent Change in eGFR Calculated Using Cystatin C | Visit 12 (Week 36) and Visit 17 (Week 52) | Percent change in eGFR calculated using cystatin C compared to baseline obtained at Visit 2. |
| Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Visits 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17 | Percent change from baseline in PCR |
| Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) and Visit 17 (Week 52) | Proportion of subjects whose best response was complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of \>50% from baseline, plus PCR≤2.5 g/g but \>0.5 g/g) of proteinuria |
| Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Visit 6, 9, 12, and 17 | Percent change from baseline of serum total cholesterol, triglycerides, LDL, HDL, Lp(a), albumin, and cortisol |
| Percent Change From Baseline in eGFR by Visit | Visit 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17 | Percent change from baseline in eGFR by visit |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean HbA1c | Week 36 | Change from baseline mean HbA1c (%) to Week 36 |
Countries
United States
Participant flow
Recruitment details
Initial recruitment target was 40 subjects.
Pre-assignment details
Adaptive design mandated closure of groups 5 & 6 with re-assignment of subjects to groups 3 & 4 if pre-defined tolerability criteria were met in 2 of first 6 patients.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Acthar 8 U (0.1 mL) Daily Repository Corticotropin Injection
Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups \[8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)\]. | 7 |
| Group 2: Placebo (0.1 mL) Daily Placebo
Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes. | 3 |
| Group 3: Acthar 16 U (0.2 mL) Daily Repository Corticotropin Injection
Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups \[8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)\]. | 14 |
| Group 4: Placebo (0.2 mL) Daily Placebo
Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes. | 6 |
| Group 5: Acthar 32 U (0.4 mL) Daily Repository Corticotropin Injection
Repository Corticotropin Injection: H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups \[8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)\]. | 3 |
| Group 6: Placebo (0.4 mL) Daily Placebo
Placebo: Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes. | 1 |
| Total | 34 |
Baseline characteristics
| Characteristic | Group 1: Acthar 8 U (0.1 mL) Daily | Group 2: Placebo (0.1 mL) Daily | Group 3: Acthar 16 U (0.2 mL) Daily | Group 4: Placebo (0.2 mL) Daily | Group 5: Acthar 32 U (0.4 mL) Daily | Group 6: Placebo (0.4 mL) Daily | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 5 Participants | 1 Participants | 1 Participants | 1 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 2 Participants | 9 Participants | 5 Participants | 2 Participants | 0 Participants | 24 Participants |
| Region of Enrollment United States | 7 participants | 3 participants | 14 participants | 6 participants | 3 participants | 1 participants | 34 participants |
| Sex: Female, Male Female | 4 Participants | 0 Participants | 9 Participants | 1 Participants | 1 Participants | 0 Participants | 15 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 5 Participants | 5 Participants | 2 Participants | 1 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 1 / 7 | 0 / 17 | 1 / 34 |
| other Total, other adverse events | 10 / 10 | 6 / 7 | 14 / 17 | 30 / 34 |
| serious Total, serious adverse events | 2 / 10 | 1 / 7 | 2 / 17 | 5 / 34 |
Outcome results
Primary
Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12
Percent change in eGFR at Visit 12 (Week 36) compared to average baseline eGFR obtained during screening
Time frame: Visit 12 (Week 36)
Population: This trial had an adaptive design that pre-specified the closure of the 32 U (units) (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12 | -24.927 percent change | Standard Error 5.4198 |
| Acthar 8 Units | Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12 | -20.563 percent change | Standard Error 6.8126 |
| Acthar 16 Units | Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12 | -17.447 percent change | Standard Error 4.3473 |
Secondary
Complete or Partial Remission of Proteinuria
Proportion of patients with complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of \>50% from baseline, plus PCR≤2.5 g/g but \>0.5 g/g) of proteinuria at Visit 12 (Week 36) and/or at Visit 17 (Week 52)
Time frame: Visit 12 (Week 36) and Visit 17 (Week 52)
Population: This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) | Complete remission | 0 Participants |
| Placebo | Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) | Partial remission | 1 Participants |
| Placebo | Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) | No remission | 8 Participants |
| Placebo | Complete or Partial Remission of Proteinuria | Visit 17 (Week 52) | Complete remission | 0 Participants |
| Placebo | Complete or Partial Remission of Proteinuria | Visit 17 (Week 52) | Partial remission | 0 Participants |
| Placebo | Complete or Partial Remission of Proteinuria | Visit 17 (Week 52) | No remission | 6 Participants |
| Acthar 8 Units | Complete or Partial Remission of Proteinuria | Visit 17 (Week 52) | No remission | 2 Participants |
| Acthar 8 Units | Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) | Complete remission | 0 Participants |
| Acthar 8 Units | Complete or Partial Remission of Proteinuria | Visit 17 (Week 52) | Complete remission | 0 Participants |
| Acthar 8 Units | Complete or Partial Remission of Proteinuria | Visit 17 (Week 52) | Partial remission | 0 Participants |
| Acthar 8 Units | Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) | Partial remission | 0 Participants |
| Acthar 8 Units | Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) | No remission | 3 Participants |
| Acthar 16 Units | Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) | Partial remission | 0 Participants |
| Acthar 16 Units | Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) | No remission | 7 Participants |
| Acthar 16 Units | Complete or Partial Remission of Proteinuria | Visit 17 (Week 52) | No remission | 7 Participants |
| Acthar 16 Units | Complete or Partial Remission of Proteinuria | Visit 17 (Week 52) | Complete remission | 1 Participants |
| Acthar 16 Units | Complete or Partial Remission of Proteinuria | Visit 12 (Week 36) | Complete remission | 1 Participants |
| Acthar 16 Units | Complete or Partial Remission of Proteinuria | Visit 17 (Week 52) | Partial remission | 0 Participants |
Secondary
Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death
Time frame: Visit 12 (Week 36) and Visit 17 (Week 52)
Population: This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 12 (Week 36) | Yes | 0 Participants |
| Placebo | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 12 (Week 36) | No | 10 Participants |
| Placebo | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 17 (Week 52) | Yes | 0 Participants |
| Placebo | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 17 (Week 52) | No | 10 Participants |
| Acthar 8 Units | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 17 (Week 52) | No | 6 Participants |
| Acthar 8 Units | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 12 (Week 36) | Yes | 1 Participants |
| Acthar 8 Units | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 17 (Week 52) | Yes | 1 Participants |
| Acthar 8 Units | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 12 (Week 36) | No | 6 Participants |
| Acthar 16 Units | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 17 (Week 52) | No | 14 Participants |
| Acthar 16 Units | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 12 (Week 36) | No | 15 Participants |
| Acthar 16 Units | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 17 (Week 52) | Yes | 2 Participants |
| Acthar 16 Units | Frequency of Patients With a Doubling of Serum Creatinine, Progression to End-stage Renal Disease (ESRD), or Death | Visit 12 (Week 36) | Yes | 1 Participants |
Secondary
Percent Change From Baseline in eGFR by Visit
Percent change from baseline in eGFR by visit
Time frame: Visit 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17
Population: This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Week 52 Endpoint | -20.69 percent change | Standard Deviation 12.433 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 15 | -17.40 percent change | Standard Deviation 14.334 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 16 | -19.16 percent change | Standard Deviation 18.686 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 17 | -18.43 percent change | Standard Deviation 12.893 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 14 | -21.88 percent change | Standard Deviation 11.695 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 5 | -8.42 percent change | Standard Deviation 14.942 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 6 | -12.73 percent change | Standard Deviation 8.881 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 7 | -12.30 percent change | Standard Deviation 6.888 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 8 | -11.64 percent change | Standard Deviation 6.539 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 9 | -14.46 percent change | Standard Deviation 8.535 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 10 | -15.75 percent change | Standard Deviation 10.914 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 11 | -14.71 percent change | Standard Deviation 12.052 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 12 | -26.09 percent change | Standard Deviation 11.687 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Week 36 Endpoint | -24.96 percent change | Standard Deviation 11.581 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 13 | -17.94 percent change | Standard Deviation 14.297 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 3 | -6.19 percent change | Standard Deviation 16.494 |
| Placebo | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 4 | -11.76 percent change | Standard Deviation 14.131 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Week 36 Endpoint | -20.27 percent change | Standard Deviation 15.818 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 14 | -33.99 percent change | Standard Deviation 20.993 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 8 | -27.46 percent change | Standard Deviation 11.435 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 13 | -29.37 percent change | Standard Deviation 10.193 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 15 | -38.05 percent change | Standard Deviation 8.677 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 6 | -9.36 percent change | Standard Deviation 14.723 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 11 | -26.13 percent change | Standard Deviation 3.041 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 16 | -40.18 percent change | Standard Deviation 5.668 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 7 | -25.42 percent change | Standard Deviation 10.079 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 9 | -21.04 percent change | Standard Deviation 8.414 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 17 | -42.70 percent change | Standard Deviation 15.255 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 5 | -10.11 percent change | Standard Deviation 9.614 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 3 | 1.82 percent change | Standard Deviation 11.347 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Week 52 Endpoint | -36.50 percent change | Standard Deviation 11.573 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 10 | -28.73 percent change | Standard Deviation 6.789 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 4 | 4.39 percent change | Standard Deviation 9.133 |
| Acthar 8 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 12 | -23.54 percent change | Standard Deviation 7.853 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 4 | -2.69 percent change | Standard Deviation 11.252 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 5 | -12.01 percent change | Standard Deviation 14.395 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 12 | -18.32 percent change | Standard Deviation 22.929 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 6 | -14.20 percent change | Standard Deviation 16.3 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 3 | 0.86 percent change | Standard Deviation 11.659 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 7 | -17.33 percent change | Standard Deviation 21.629 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 8 | -17.58 percent change | Standard Deviation 23.071 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Week 36 Endpoint | -17.55 percent change | Standard Deviation 19.655 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 9 | -23.25 percent change | Standard Deviation 18.344 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 10 | -20.57 percent change | Standard Deviation 23.747 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 14 | -29.96 percent change | Standard Deviation 18.97 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 15 | -19.95 percent change | Standard Deviation 18.899 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 16 | -27.33 percent change | Standard Deviation 16.709 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 11 | -19.05 percent change | Standard Deviation 20.996 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 17 | -24.55 percent change | Standard Deviation 22.322 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Visit 13 | -23.46 percent change | Standard Deviation 25.49 |
| Acthar 16 Units | Percent Change From Baseline in eGFR by Visit | Baseline to Week 52 Endpoint | -22.44 percent change | Standard Deviation 20.669 |
Secondary
Percent Change From Baseline in Protein to Creatinine Ratio (PCR)
Percent change from baseline in PCR
Time frame: Visits 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17
Population: This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 9 | 27.1483 percent change | Standard Error 60.7296 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 6 | -8.3326 percent change | Standard Error 36.44142 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 14 | 1.1894 percent change | Standard Error 44.40008 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 10 | 8.2594 percent change | Standard Error 45.36335 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 5 | -13.6630 percent change | Standard Error 25.57771 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Week 36 Endpoint | 19.1847 percent change | Standard Error 93.07542 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 11 | 15.1205 percent change | Standard Error 92.21718 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 17 | 20.8644 percent change | Standard Error 88.18113 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 12 | 21.3540 percent change | Standard Error 98.45289 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 7 | 2.4621 percent change | Standard Error 43.42213 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 4 | 0.3837 percent change | Standard Error 31.26202 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 16 | 0.0025 percent change | Standard Error 47.25812 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 8 | 12.6601 percent change | Standard Error 51.03925 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Week 52 Endpoint | 32.9735 percent change | Standard Error 78.62621 |
| Placebo | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 15 | 0.6294 percent change | Standard Error 34.89553 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Week 36 Endpoint | 34.8848 percent change | Standard Error 25.06961 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 4 | 44.7508 percent change | Standard Error 78.75623 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 5 | 47.4429 percent change | Standard Error 54.03221 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 6 | 72.1740 percent change | Standard Error 85.2035 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 7 | 55.9950 percent change | Standard Error 42.92855 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 8 | 53.2134 percent change | Standard Error 43.68087 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 9 | 82.7319 percent change | Standard Error 67.83831 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 10 | 18.9898 percent change | — |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 11 | 69.8646 percent change | Standard Error 63.88789 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 12 | 59.8357 percent change | Standard Error 55.64981 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Week 52 Endpoint | 66.7698 percent change | Standard Error 84.63637 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 14 | 11.7663 percent change | Standard Error 5.63288 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 15 | 4.3807 percent change | Standard Error 6.70067 |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 16 | 21.7536 percent change | — |
| Acthar 8 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 17 | 19.1625 percent change | Standard Error 40.46023 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 9 | 3.6409 percent change | Standard Error 54.51979 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 17 | -6.2356 percent change | Standard Error 72.81798 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 14 | -16.4956 percent change | Standard Error 52.71778 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 8 | -8.5381 percent change | Standard Error 65.06657 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 5 | 2.0594 percent change | Standard Error 59.12062 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 15 | 0.0091 percent change | Standard Error 81.37129 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 7 | -10.6879 percent change | Standard Error 50.13402 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Week 52 Endpoint | 12.1049 percent change | Standard Error 87.56153 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 16 | 3.6555 percent change | Standard Error 74.40718 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 11 | 0.4566 percent change | Standard Error 71.78576 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 6 | -1.6086 percent change | Standard Error 47.69994 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 12 | 14.4619 percent change | Standard Error 66.58 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 10 | -6.7500 percent change | Standard Error 64.47765 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Week 36 Endpoint | 50.2732 percent change | Standard Error 85.87435 |
| Acthar 16 Units | Percent Change From Baseline in Protein to Creatinine Ratio (PCR) | Baseline to Visit 4 | 32.5701 percent change | Standard Error 71.34201 |
Secondary
Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol
Percent change from baseline of serum total cholesterol, triglycerides, LDL, HDL, Lp(a), albumin, and cortisol
Time frame: Visit 6, 9, 12, and 17
Population: This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Visit 17 | 22.6 percent change | Standard Deviation 62.47 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Visit 9 | 13.9 percent change | Standard Deviation 22.9 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Visit 12 | 3.4 percent change | Standard Deviation 22.97 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Week 36 Endpoint | 3.9 percent change | Standard Deviation 21.74 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Visit 17 | 6.3 percent change | Standard Deviation 20.82 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Week 52 Endpoint | 6.3 percent change | Standard Deviation 20.82 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Visit 6 | 1.6 percent change | Standard Deviation 32.24 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Visit 9 | 18.4 percent change | Standard Deviation 34.74 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Visit 12 | 8.3 percent change | Standard Deviation 40.39 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Week 36 Endpoint | 8.9 percent change | Standard Deviation 38.12 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Visit 6 | -7.2 percent change | Standard Deviation 8.15 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Week 52 Endpoint | 22.6 percent change | Standard Deviation 62.47 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Visit 6 | -4.8 percent change | Standard Deviation 28.04 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Visit 9 | 16.9 percent change | Standard Deviation 33.3 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Visit 12 | 16.0 percent change | Standard Deviation 45.78 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Week 36 Endpoint | 15.9 percent change | Standard Deviation 43.16 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Visit 17 | 7.4 percent change | Standard Deviation 23.12 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Week 52 Endpoint | 7.4 percent change | Standard Deviation 23.12 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Visit 6 | -3.2 percent change | Standard Deviation 14.03 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Visit 9 | 0.0 percent change | Standard Deviation 11.52 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Visit 12 | 3.7 percent change | Standard Deviation 26.98 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Week 36 Endpoint | 2.8 percent change | Standard Deviation 25.59 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Visit 17 | -5.0 percent change | Standard Deviation 7.15 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Week 52 Endpoint | -5.0 percent change | Standard Deviation 7.15 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Visit 6 | -7.2 percent change | Standard Deviation 14.3 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Visit 9 | 1.9 percent change | Standard Deviation 20.24 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Visit 12 | 6.1 percent change | Standard Deviation 31.56 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Week 36 Endpoint | 7.5 percent change | Standard Deviation 30.07 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Visit 17 | 28.5 percent change | Standard Deviation 57.71 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Week 52 Endpoint | 28.5 percent change | Standard Deviation 57.71 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Visit 6 | -1.92 percent change | Standard Deviation 4.848 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Visit 9 | -2.49 percent change | Standard Deviation 6.685 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Visit 12 | -0.89 percent change | Standard Deviation 6.798 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Week 36 Endpoint | -1.42 percent change | Standard Deviation 6.629 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Visit 17 | -0.22 percent change | Standard Deviation 9.002 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Week 52 Endpoint | -1.77 percent change | Standard Deviation 8.822 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Visit 6 | -5.86 percent change | Standard Deviation 28.676 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Visit 9 | -11.23 percent change | Standard Deviation 22.791 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Visit 12 | -9.44 percent change | Standard Deviation 39.28 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Week 36 Endpoint | -8.36 percent change | Standard Deviation 37.189 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Visit 17 | -13.11 percent change | Standard Deviation 31.825 |
| Placebo | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Week 52 Endpoint | -8.53 percent change | Standard Deviation 28.727 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Visit 6 | -9.79 percent change | Standard Deviation 7.256 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Visit 12 | 23.2 percent change | Standard Deviation 45.4 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Week 36 Endpoint | 42.0 percent change | Standard Deviation 48.66 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Week 36 Endpoint | -5.96 percent change | Standard Deviation 10.357 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Visit 17 | -9.9 percent change | Standard Deviation 12.73 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Week 52 Endpoint | 43.2 percent change | Standard Deviation 66.57 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Week 36 Endpoint | 63.46 percent change | Standard Deviation 125.208 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Visit 6 | 11.8 percent change | Standard Deviation 8.94 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Visit 17 | 8.06 percent change | Standard Deviation 15.119 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Visit 9 | 9.8 percent change | Standard Deviation 4.12 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Visit 12 | 11.4 percent change | Standard Deviation 2.7 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Week 36 Endpoint | 6.7 percent change | Standard Deviation 7.83 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Week 52 Endpoint | -6.15 percent change | Standard Deviation 14.379 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Visit 17 | 3.0 percent change | Standard Deviation 12.26 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Week 52 Endpoint | -0.2 percent change | Standard Deviation 17.5 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Week 52 Endpoint | 51.82 percent change | Standard Deviation 91.328 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Visit 6 | 35.9 percent change | Standard Deviation 95.42 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Visit 6 | 45.08 percent change | Standard Deviation 151.882 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Visit 9 | 1.2 percent change | Standard Deviation 9.32 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Visit 12 | 23.3 percent change | Standard Deviation 20.74 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Visit 17 | 84.26 percent change | Standard Deviation 88.861 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Week 36 Endpoint | 49.2 percent change | Standard Deviation 85.05 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Visit 9 | 14.44 percent change | Standard Deviation 26.399 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Visit 6 | 34.1 percent change | Standard Deviation 23.94 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Visit 17 | 19.9 percent change | Standard Deviation 24.25 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Visit 9 | 20.3 percent change | Standard Deviation 27.82 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Visit 12 | 11.1 percent change | Standard Deviation 24.57 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Week 36 Endpoint | 26.4 percent change | Standard Deviation 28.05 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Week 52 Endpoint | 55.6 percent change | Standard Deviation 85.65 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Visit 17 | -12.1 percent change | Standard Deviation 1.57 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Week 52 Endpoint | 26.8 percent change | Standard Deviation 45.79 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Visit 6 | 30.0 percent change | Standard Deviation 34.97 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Visit 9 | 7.9 percent change | Standard Deviation 36.59 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Visit 12 | -7.1 percent change | Standard Deviation 25.12 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Visit 12 | 17.72 percent change | Standard Deviation 35.704 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Week 36 Endpoint | 48.8 percent change | Standard Deviation 141.71 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Visit 9 | -7.77 percent change | Standard Deviation 8.638 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Visit 17 | -37.4 percent change | Standard Deviation 18.78 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Week 52 Endpoint | 33.5 percent change | Standard Deviation 76.59 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Visit 6 | 47.4 percent change | Standard Deviation 35.4 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Visit 12 | -2.67 percent change | Standard Deviation 14.597 |
| Acthar 8 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Visit 9 | 36.1 percent change | Standard Deviation 50.37 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Visit 17 | 27.7 percent change | Standard Deviation 63 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Visit 9 | 31.0 percent change | Standard Deviation 65.7 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Visit 12 | 26.4 percent change | Standard Deviation 74.6 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Week 52 Endpoint | 30.21 percent change | Standard Deviation 89.88 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Visit 6 | 10.1 percent change | Standard Deviation 29.82 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Week 36 Endpoint | 12.4 percent change | Standard Deviation 54.63 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Visit 6 | -3.78 percent change | Standard Deviation 9.721 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Visit 9 | -3.75 percent change | Standard Deviation 10.749 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Visit 17 | 25.9 percent change | Standard Deviation 86.13 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Week 36 Endpoint | -7.23 percent change | Standard Deviation 6.083 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Visit 9 | 14.2 percent change | Standard Deviation 25.95 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Week 52 Endpoint | 24.1 percent change | Standard Deviation 76.69 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Visit 17 | 21.7 percent change | Standard Deviation 65.09 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Visit 12 | 29.2 percent change | Standard Deviation 61.09 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Visit 6 | 18.1 percent change | Standard Deviation 35.97 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Visit 12 | 11.1 percent change | Standard Deviation 32.58 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Visit 9 | 50.08 percent change | Standard Deviation 135.687 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Visit 9 | 3.4 percent change | Standard Deviation 11.34 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Visit 17 | -2.33 percent change | Standard Deviation 5.898 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Visit 6 | 8.1 percent change | Standard Deviation 42.39 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Visit 12 | -6.9 percent change | Standard Deviation 13.21 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Week 36 Endpoint | 64.32 percent change | Standard Deviation 187.125 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Week 36 Endpoint | 12.9 percent change | Standard Deviation 24.22 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Week 36 Endpoint | 19.0 percent change | Standard Deviation 58.4 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Week 52 Endpoint | 18.2 percent change | Standard Deviation 59.15 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Week 36 Endpoint | 19.9 percent change | Standard Deviation 38.54 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Visit 17 | -9.2 percent change | Standard Deviation 15.91 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Week 52 Endpoint | -2.75 percent change | Standard Deviation 6.207 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Visit 17 | 9.6 percent change | Standard Deviation 33.08 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | HDL-C - Baseline to Week 52 Endpoint | -3.2 percent change | Standard Deviation 21.37 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Week 52 Endpoint | 21.2 percent change | Standard Deviation 58.11 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Visit 12 | 52.77 percent change | Standard Deviation 97.269 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Visit 6 | 22.7 percent change | Standard Deviation 41.97 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Total cholesterol - Baseline to Week 52 Endpoint | 9.4 percent change | Standard Deviation 30.28 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Visit 17 | 7.09 percent change | Standard Deviation 24.739 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Visit 9 | 28.0 percent change | Standard Deviation 67.6 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Cortisol - Baseline to Visit 6 | 180.70 percent change | Standard Deviation 237.206 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | LDL-C - Baseline to Visit 9 | 24.5 percent change | Standard Deviation 48.65 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Visit 12 | 10.7 percent change | Standard Deviation 41.39 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Triglycerides - Baseline to Visit 6 | 20.5 percent change | Standard Deviation 58.06 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Serum albumin - Baseline to Visit 12 | -4.09 percent change | Standard Deviation 4.507 |
| Acthar 16 Units | Percent Change From Baseline of Serum Total Cholesterol, Triglycerides, LDL, HDL, Lp(a), Albumin, and Cortisol | Lp(a) - Baseline to Week 36 Endpoint | 16.9 percent change | Standard Deviation 48.51 |
Secondary
Percent Change in eGFR at Visit 17
Percent change in eGFR at Visit 17 (Week 52) compared to baseline eGFR obtained during screening
Time frame: Visit 17 (Week 52)
Population: This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Change in eGFR at Visit 17 | -20.407 percent change | Standard Error 6.0183 |
| Acthar 8 Units | Percent Change in eGFR at Visit 17 | -37.456 percent change | Standard Error 7.8387 |
| Acthar 16 Units | Percent Change in eGFR at Visit 17 | -22.097 percent change | Standard Error 5.4619 |
Secondary
Percent Change in eGFR Calculated Using Cystatin C
Percent change in eGFR calculated using cystatin C compared to baseline obtained at Visit 2.
Time frame: Visit 12 (Week 36) and Visit 17 (Week 52)
Population: This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percent Change in eGFR Calculated Using Cystatin C | Visit 12 (Week 36) | -14.25 percent change | Standard Deviation 17.155 |
| Placebo | Percent Change in eGFR Calculated Using Cystatin C | Visit 17 (Week 52) | 1.14 percent change | Standard Deviation 21.155 |
| Acthar 8 Units | Percent Change in eGFR Calculated Using Cystatin C | Visit 12 (Week 36) | -11.49 percent change | Standard Deviation 10.334 |
| Acthar 8 Units | Percent Change in eGFR Calculated Using Cystatin C | Visit 17 (Week 52) | -35.90 percent change | Standard Deviation 1.509 |
| Acthar 16 Units | Percent Change in eGFR Calculated Using Cystatin C | Visit 12 (Week 36) | -10.24 percent change | Standard Deviation 22.066 |
| Acthar 16 Units | Percent Change in eGFR Calculated Using Cystatin C | Visit 17 (Week 52) | -12.43 percent change | Standard Deviation 20.522 |
Secondary
Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria
Proportion of subjects whose best response was complete remission (PCR 0.5 g/g) or partial remission (reduction in PCR of \>50% from baseline, plus PCR≤2.5 g/g but \>0.5 g/g) of proteinuria
Time frame: Visit 12 (Week 36) and Visit 17 (Week 52)
Population: This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Week 36 | Complete remission | 0 Participants |
| Placebo | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Week 36 | Partial remission | 1 Participants |
| Placebo | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Week 36 | No remission | 9 Participants |
| Placebo | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Between Week 36 and Week 52 | Complete remission | 0 Participants |
| Placebo | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Between Week 36 and Week 52 | Partial remission | 0 Participants |
| Placebo | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Between Week 36 and Week 52 | No remission | 8 Participants |
| Acthar 8 Units | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Between Week 36 and Week 52 | No remission | 2 Participants |
| Acthar 8 Units | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Week 36 | Complete remission | 0 Participants |
| Acthar 8 Units | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Between Week 36 and Week 52 | Complete remission | 0 Participants |
| Acthar 8 Units | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Between Week 36 and Week 52 | Partial remission | 0 Participants |
| Acthar 8 Units | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Week 36 | Partial remission | 0 Participants |
| Acthar 8 Units | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Week 36 | No remission | 7 Participants |
| Acthar 16 Units | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Week 36 | Partial remission | 3 Participants |
| Acthar 16 Units | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Week 36 | No remission | 12 Participants |
| Acthar 16 Units | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Between Week 36 and Week 52 | No remission | 5 Participants |
| Acthar 16 Units | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Between Week 36 and Week 52 | Complete remission | 1 Participants |
| Acthar 16 Units | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Week 36 | Complete remission | 1 Participants |
| Acthar 16 Units | Proportion of Subjects Whose Best Response Was Complete or Partial Remission of Proteinuria | Between Week 36 and Week 52 | Partial remission | 2 Participants |
Other Pre-specified
Change in Mean HbA1c
Change from baseline mean HbA1c (%) to Week 36
Time frame: Week 36
Population: This trial had an adaptive design that pre-specified the closure of the 32 U arm (Group 5) in the event Acthar was not well tolerated at that dose. Based on tolerability, all patients initially included in the 32 U arm were combined with the 16 U arm (Group 3).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change in Mean HbA1c | -0.22 %HbA1c | Standard Deviation 0.694 |
| Acthar 8 Units | Change in Mean HbA1c | -0.33 %HbA1c | Standard Deviation 1.429 |
| Acthar 16 Units | Change in Mean HbA1c | -0.25 %HbA1c | Standard Deviation 0.729 |