A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447147
• Other study ID #: CL005_140
• Status: Completed
• Phase: Phase 2
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: August 2023
• Source: ChemoCentryx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Placebo
Placebo capsules once daily
• CCX140-B
CCX140-B capsules once daily (Group B)
• CCX140-B
CCX140-B capsules once daily (Group C)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ChemoCentryx

Countries where clinical trial is conducted

Belgium,  Czechia,  Germany,  Hungary,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject incidence of adverse events	The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy.	Up to 365 days
Secondary	Change from baseline in first morning urinary albumin:creatinine ratio (ACR)		Up to 365 days