Overview

This trial is active, not recruiting.

Condition immunoglobulin a nephropathy
Treatment ccx168
Phase phase 2
Sponsor ChemoCentryx
Start date February 2015
End date September 2016
Trial size 5 participants
Trial identifier NCT02384317, CL005_168

Summary

This is a pilot study to test safety, tolerability, and efficacy of CCX168 in reducing proteinuria in patients with Immunoglobulin A nephropathy and persistent proteinuria despite supportive therapy with a maximally tolerated RAAS blocker.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
BID for 84 days
ccx168
BID for 84 days

Primary Outcomes

Measure
Safety of CCX168 in subjects with Immunoglobulin A nephropathy measured by number of patients with adverse events
time frame: 169 days

Secondary Outcomes

Measure
Evaluate the efficacy of CCX168 based on numbers of patients with improvement in proteinuria
time frame: 169 days

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: - Diagnosis of Immunoglobulin A nephropathy - estimated glomerular filtration rate >60 mL/min/1.73 m2 - Proteinuria (first morning urinary protein:creatinine ratio >1g/g creatinine) Key Exclusion Criteria: - Severe renal disease - Pregnant or nursing - Proteinuria >8g/g creatinine or >8g/day - Systemic manifestations of Henoch-Schonlein purpura within 2 years prior - Patients with Immunoglobulin A nephropathy deemed secondary to underlying disease - Biopsy reported severe crescentic Immunoglobulin A nephropathy - History of treatment with glucocorticoids, cyclophosphamide, azathioprine, mycophenolate mofetil, or any biologic immunomodulatory agent with 24 weeks prior - History of clinically significant cardiac conditions - History of cancer within 5 years prior - Any infection requiring antibiotic treatment that has not cleared prior to study start

Additional Information

Official title An Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Immunoglobulin A Nephropathy on Stable RAAS Blockade
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by ChemoCentryx.