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

NCT02384317 | Completed Phase 2 Results

• 2 other identifiers: CL005_1682014-003402-33
• Study Type: interventional
• Target: 7
• Locations: 2 countries
• Sites: 6

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.

Conditions

Immunoglobulin A Nephropathy

Outcome Measures

Primary Outcomes (3)

• Change in Slope of First Morning Urinary PCR From the 8-week RAAS Blocker run-in Period to the 12-week CCX168 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

  Week -8 to -1 (Run-in period) and Week 1 to 12 (treatment period)

• Number of Participants With AE's

  Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)

  Day 0 - Day 169 (throughout the trial)

• Severity of Adverse Events (AE's)

  Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)

  Day 0 - Day 169 (throughout the trial)

Secondary Outcomes (7)

• Proportion of Subjects Achieving Renal Response From Baseline to Day 85

  Baseline and Day 85

• Proportion of Subjects Achieving a Partial Renal Response From Baseline to Day 85

  Baseline and Day 85

• Change From Baseline to Day 85 in Vital Signs

  Baseline to day 85

• Change in Systolic Blood Pressure From Baseline to Day 85

  Baseline to day 85

• Change in Diastolic Blood Pressure From Baseline to Day 85

  Baseline to day 85

Study Arms (1)

CCX168 (Avacopan)

EXPERIMENTAL

CCX168 (Avacopan) plus stable dose of RAAS blocker

Drug: CCX168

Interventions

CCX168 DRUG

CCX168 30 mg, twice daily (b.i.d.) orally for 84 days (12 weeks). The CCX168 dose was taken in the morning, optimally within one hour after breakfast, and in the evening, optimally within one hour after dinner.

CCX168 (Avacopan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (6)

Unknown Facility

Palo Alto, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Reno, Nevada, United States

Location

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Stockholm, Sweden

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

avacopan

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: ChemoCentryx

medinfo@amgen.com

650-210-2900

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: March 10, 2015
• Study Start: March 27, 2015
• Primary Completion: September 13, 2015
• Study Completion: June 1, 2018
• Last Updated: March 13, 2025
• Results First Posted: August 1, 2023

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (5); SE (1)