Primary IgA nephropathy patients at risk of developing end stage renal disease MedDRA version: 20.0 Level: LLT Classification code 10069341 Term: Berger's disease System Organ Class: 100000004857
Conditions
Interventions
Product Name: Nefecon
Product Code: Nefecon
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration
Sponsors
Calliditas Therapeutics AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Completed Study Nef-301, defined as Part A (9-month study drug treatment [Nefecon 16 mg/day or placebo] and 3-month follow-up) and Part B (12-month follow-up); -Completed Visit 17b in Study Nef-301 within 3 months before Study Visit 3; -On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or maximum tolerated dose according to the 2012 KDIGO guidelines21 (see Appendix C). A stable dose is defined as a dose within 25% of the dose at Visit 17a or 17b in Study Nef 301; and -Proteinuria based on 2 consecutive measurements (24-hour urine sampling) after informed consent, separated by at least 2 weeks and calculated by the central laboratory. Both samples of the same parameter must show either of the following: oProteinuria >/=1 g/day (>/=1000 mg/day) in 2 consecutive measurements; or oUPCR >/=0.8 g/gram (?90 mg/mmol) in 2 consecutive measurements; and -eGFR >/=30 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula confirmed by the central laboratory at Study Visit 1 or Study Visit 3. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 227 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: -Had a dose reduction to Nefecon 8 mg/day in Study Nef-301; -Systemic diseases that may cause mesangial IgA deposition including, but not limited to, Henoch Schönlein purpura, systemic lupus erythematosus, dermatitis herpetiformis, and ankylosing spondylitis; -Patients with nephrotic syndrome (i.e., proteinuria >3.5 g/day and with serum albumin /=140 mmHg systolic blood pressure or >/=90 mmHg diastolic blood pressure are not eligible. At least 1 blood pressure measurement at either Study Visit 1 or Study Visit 3 should be within these limits (based on up to 3 measurements, measured 1 minute apart, after resting in the supine position for at least 5 minutes); -Patients who have received rescue therapy with systemic immunosuppressants, including GCSs, during Study Nef-301; -Patients who have been treated with any systemic GCSs within the 3 months before screening; -Patients who have been treated with any systemic GCSs within the 12 months before screening except for a maximum of 3 periods of 2 weeks with the equivalent of 0.5 mg/kg/day prednisolone or less for non-IgAN indications;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the effect of 9 months of retreatment with Nefecon on urine protein to creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR) in patients who completed Study Nef 301 with Nefecon treatment; and •To assess the effect of 9 months of treatment with Nefecon on UPCR and eGFR in patients who completed Study Nef-301 with placebo treatment. ;Secondary Objective: •To assess the safety and tolerability of 9 months of retreatment with Nefecon in patients who completed Study Nef-301 with Nefecon treatment; •To assess the safety and tolerability of 9 months of treatment with Nefecon in patients who completed Study Nef-301 with placebo treatment; •To assess the effect of 9 months of retreatment with Nefecon on additional aspects of renal function in patients who completed Study Nef-301 with Nefecon treatment; and •To assess the effect of 9 months of treatment with Nefecon on additional aspects of renal function in patients who completed Study Nef-301 with placebo treatment. ;Primary end point(s): •Ratio of eGFR at 9 months compared to baseline, calculated using the CKD-EPI formula; and •Ratio of UPCR at 9 months compared to baseline. ;Timepoint(s) of evaluation of this end point: included in E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Ratio of urine albumin to creatinine ratio (UACR) at 9 months compared to baseline; •Short Form 36 quality of life assessment at 12 months compared to baseline; •Proportion of patients with microhematuria at 9 months compared to baseline; •Proportion of patients receiving rescue treatment and time to receiving rescue treatment; •Proportion of patients on dialysis, undergoing kidney transplantation, or with eGFR <15 mL/min per 1.73 m2; and •Cortisol suppression at 9 and 12 months, measured as urinary cortisol excretion over 24 hours compared to baseline. ;Timepoint(s) of evaluation of this end point: included in E.5.2 | — |
Countries
Argentina, Australia, Belarus, Belgium, Canada, Czech Republic, Finland, France, Germany, Greece, Italy, Korea, Republic of, Poland, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Operations
Calliditas Therapeutics AB
Outcome results
None listed