Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade

Phase 2

Completed

• Conditions: Immunoglobulin A Nephropathy
• Interventions: Drug: CCX168

• Registration Number: NCT02384317
• Lead Sponsor: Amgen

Brief Summary

The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with IgAN on background supportive therapy with a maximally tolerated dose of RAAS blockade. The primary efficacy objective is to evaluate the efficacy of CCX168 based on an improvement in proteinuria.

Detailed Description

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Study Timeline

• Study First Submitted: 2015-02-11
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-10
• Study Start: 2015-03-27
• Primary Completion: 2015-09-13
• Study Completion: 2018-06-01
• Results First Submitted: 2023-06-30
• Results First Submitted QC: 2023-07-31
• Results First Posted: 2023-08-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCX168 (Avacopan)	CCX168	CCX168 (Avacopan) plus stable dose of RAAS blocker

Primary Outcome Measures

Name	Time	Method
Change in Slope of First Morning Urinary PCR From the 8-week RAAS Blocker run-in Period to the 12-week CCX168 Treatment Period	Week -8 to -1 (Run-in period) and Week 1 to 12 (treatment period)	The mean change in the slope of the urinary protein:creatinine ratio (UPCR, in mg/g/week) between the 8-week run-in period and the 12-week treatment period
Number of Participants With AE's	Day 0 - Day 169 (throughout the trial)	Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Severity of Adverse Events (AE's)	Day 0 - Day 169 (throughout the trial)	Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Achieving Renal Response From Baseline to Day 85	Baseline and Day 85	Renal Response defined as an improvement in proteinuria based on a decrease from baseline to Day 85 in proteinuria to a level \<300 mg/g creatinine and maintaining eGFR within 15% of baseline.
Proportion of Subjects Achieving a Partial Renal Response From Baseline to Day 85	Baseline and Day 85	A partial renal response, defined as an improvement in proteinuria based on a decrease from baseline to Day 85 in proteinuria to a level \<1 g/g creatinine and maintaining eGFR within 15% of baseline.
Change in Systolic Blood Pressure From Baseline to Day 85	Baseline to day 85
Change From Baseline to Day 85 in Vital Signs	Baseline to day 85
Change in Diastolic Blood Pressure From Baseline to Day 85	Baseline to day 85
Change in Temperature From Baseline to Day 85	Baseline to day 85
Change in Weight From Baseline to Day 85	Baseline to day 85