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

Immunoglobulin A Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02384317
• Other study ID #: CL005_168
• Secondary ID: 2014-003402-33
• Status: Completed
• Phase: Phase 2
• Start date: March 27, 2015
• Est. completion date: June 1, 2018

Study information

• Verified date: July 2023
• Source: ChemoCentryx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 1, 2018
• Est. primary completion date: September 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• Immunoglobulin A Nephropathy
• Kidney Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ChemoCentryx

Countries where clinical trial is conducted

United States,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Number of Participants With AE's	Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)	Day 0 - Day 169 (throughout the trial)
Primary	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	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
Secondary	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
Secondary	Change From Baseline to Day 85 in Vital Signs		Baseline to day 85
Secondary	Change in Systolic Blood Pressure From Baseline to Day 85		Baseline to day 85
Secondary	Change in Diastolic Blood Pressure From Baseline to Day 85		Baseline to day 85
Secondary	Change in Temperature From Baseline to Day 85		Baseline to day 85
Secondary	Change in Weight From Baseline to Day 85		Baseline to day 85