Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy
Lead Sponsor:
Amgen
Conditions:
Diabetic Nephropathy
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT01447147
Start Date
October 1 2011
End Date
December 1 2014
Last Update
February 27 2025
Active Locations (83)
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1
Antwerp, Belgium
2
Brussels, Belgium
3
Edegem, Belgium
4
Ghent, Belgium