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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-27

Study Completion Date

2018-06-01

Brief Summary

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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.

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Detailed Description

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

Conditions

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Immunoglobulin A Nephropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CCX168 (Avacopan)

CCX168 (Avacopan) plus stable dose of RAAS blocker

Group Type EXPERIMENTAL

CCX168

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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)

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No