A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy
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|ClinicalTrials.gov Identifier: NCT01447147|
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : December 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Nephropathy Type 2 Diabetes Mellitus||Drug: Placebo Drug: CCX140-B||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||332 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Diabetic Nephropathy|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||December 2014|
|Placebo Comparator: Placebo (Group A)||
Placebo capsules once daily
|Experimental: CCX140-B (Group B)||
CCX140-B capsules once daily (Group B)
|Experimental: CCX140-B (Group C)||
CCX140-B capsules once daily (Group C)
- Subject incidence of adverse events [ Time Frame: 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.
- Change from baseline in first morning urinary albumin:creatinine ratio (ACR) [ Time Frame: Up to 365 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447147
|Study Director:||Pirow Bekker, MD, PhD||ChemoCentryx|