Diabetic Nephropathy, Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy based on subject incidence of adverse events. The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes and renal medications. Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Interventions
DRUGPlacebo
Placebo capsules once daily
DRUGCCX140-B
CCX140-B capsules once daily (Group B)
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association \[ADA\] criteria) * Residual albuminuria despite stable treatment with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening (Albumin:creatinine ratio \[ACR\] of 100 to 3000 mg/g creatinine, inclusive) * Estimated glomerular filtration rate based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease \[MDRD\] equation) of ≥ 25 mL/min/1.73 m(2) * Must be on a stable dose of an ACE inhibitor or ARB for at least 8 weeks prior to screening, but subjects must not be on both an ACE inhibitor and an ARB * Hemoglobin A1c (HbA1c) \> 6.0% but not \> 10.0% and fasting plasma glucose less than 270 mg/dL at screening Key
Exclusion criteria
* Type 1 diabetes mellitus or history of diabetic ketoacidosis * Previous renal transplant or known non-diabetic renal disease, except related to hypertension * Undergone renal dialysis at any time in the past * Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening * Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening * Received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (NSAID) treatment within 2 weeks of screening * Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening * Poorly-controlled blood pressure (systolic blood pressure \>155 or diastolic blood pressure \>95, with blood pressure measured in the seated position after at least 5 minutes of rest)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject incidence of adverse events | Up to 365 days | The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy. |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in first morning urinary albumin:creatinine ratio (ACR) | Up to 365 days |
Countries
Belgium, Czechia, Germany, Hungary, Poland, United Kingdom
Outcome results
None listed