Study to evaluate the effect of CCX140-B on albuminuria in subjects with type 2 diabetes mellitus

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus with albuminuria; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN81307356
• Lead Sponsor: ChemoCentryx, Inc. (USA)

Brief Summary

1. 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26268910 (added 18/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-02
• Study Completion: 2012-06-30
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Male or female, aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association [ADA] criteria)
2. Albumin:creatinine ratio (ACR) of 200 to 3000 mg/g creatinine, inclusive, based on two values obtained from two first morning urine samples taken on two separate days during the screening period
3. Estimated glomerular filtration rate based on serum creatinine (eGFR), determined by Modification of Diet in Renal Disease [MDRD] equation of greater than or equal to 25 mL/min/1.73 m2
4. Must be on a stable dose of an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) for at least 8 weeks prior to screening
5. 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. Has 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 (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

Primary Outcome Measures

Name	Time	Method
<br> 1. Change from baseline in 24-hour urinary albumin excretion over 84 days<br> 2. Subject incidence of adverse events over 84 days<br>

Secondary Outcome Measures

Name	Time	Method
Change in baseline of hemoglobin A1c over 84 days