Clinical trial to evaluate the safety and efficacy of CCX140-B in diabetic nephropathy

Phase 2

Completed

• Conditions: Diabetic nephropathy; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN77691094
• Lead Sponsor: ChemoCentryx, Inc. (USA)

Brief Summary

2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26268910

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-12
• Study Completion: 2012-08-31
• Last Update Posted: 8 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1. Aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (as per American Diabetes Association [ADA] criteria)
2. 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 200 to 3000 mg/g creatinine, inclusive)
3. Estimated glomerular filtration rate (eGFR) based on serum creatinine determined by Modification of Diet in Renal Disease [MDRD] equation of greater than or equal to 25 mL/min/1.73 m(2)
4. 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
5. Hemoglobin A1c (HbA1c) > 6.0% but not > 10.0% and fasting plasma glucose less than 270 mg/dL at screening

Exclusion Criteria

1. Type 1 diabetes mellitus or history of diabetic ketoacidosis
2. Previous renal transplant or known non-diabetic renal disease, except related to hypertension
3. Undergone renal dialysis at any time in the past
4. Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening
5. Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening
6. Received chronic (more than 7 days continuously) non-steroidal anti-inflammatory drug (NSAID) treatment within 2 weeks of screening
7. Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening
8. 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified