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


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
BID for 84 days
BID for 84 days

Primary Outcomes

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

Secondary Outcomes

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 July 2016.
Information provided to ClinicalTrials.gov by ChemoCentryx.