Clinical trial NCT02384317: Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Immunoglobulin A Nephropathy
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-03-10
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Slope of First Morning Urinary PCR From the 8-week RAAS Blocker run-in Period to the 12-week CCX168 Treatment Period
timeFrame: Week -8 to -1 (Run-in period) and Week 1 to 12 (treatment period)
measure: Number of Participants With AE's
timeFrame: Day 0 - Day 169 (throughout the trial)
measure: Severity of Adverse Events (AE's)
timeFrame: Day 0 - Day 169 (throughout the trial)
Secondary outcomes:
measure: Proportion of Subjects Achieving Renal Response From Baseline to Day 85
timeFrame: Baseline and Day 85
measure: Proportion of Subjects Achieving a Partial Renal Response From Baseline to Day 85
timeFrame: Baseline and Day 85
measure: Change From Baseline to Day 85 in Vital Signs
timeFrame: Baseline to day 85
measure: Change in Systolic Blood Pressure From Baseline to Day 85
timeFrame: Baseline to day 85
measure: Change in Diastolic Blood Pressure From Baseline to Day 85
timeFrame: Baseline to day 85
measure: Change in Temperature From Baseline to Day 85
timeFrame: Baseline to day 85
measure: Change in Weight From Baseline to Day 85
timeFrame: Baseline to day 85
Other outcomes:
Locations:
city: Palo Alto
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Reno
country: United States
state: Nevada
city: Chapel Hill
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Stockholm
country: Sweden
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: