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

An Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Immunoglobulin A Nephropathy on Stable RAAS Blockade

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.

Study Overview

• Status: Completed
• Conditions: Immunoglobulin A Nephropathy
• Intervention / Treatment: Drug: CCX168

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
• United States
  • California
    • Palo Alto, California, United States
    • San Francisco, California, United States
  • Nevada
    • Reno, Nevada, United States
  • North Carolina
    • Chapel Hill, North Carolina, United States
  • Ohio
    • Columbus, Ohio, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CCX168 (Avacopan); CCX168 (Avacopan) plus stable dose of RAAS blocker	Drug: CCX168; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects Achieving Renal Response From Baseline to 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.	Baseline and Day 85
Proportion of Subjects Achieving a Partial Renal Response From Baseline to 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.	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
Change in Temperature From Baseline to Day 85		Baseline to day 85
Change in Weight From Baseline to Day 85		Baseline to day 85

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2015
• Primary Completion (Actual): September 13, 2015
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: February 11, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimated): March 10, 2015

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: CL005_168; 2014-003402-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR