Phase 2
Completed N=7
Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade
Source: ClinicalTrials.gov NCT02384317 ↗Enrolled (actual)
7
Serious AEs
14.3%
Results posted
Aug 2023
Primary outcomePrimary: Change in Slope of First Morning Urinary PCR From the 8-week RAAS Blocker run-in Period to the 12-week CCX168 Treatment Period — -2.4; 15.3; -23.9 mg/g/week — p=0.965
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
-2.4; 15.3; -23.9 | 0.965 |
| PRIMARY Number of Participants With AE's |
7; 1; 5 | — |
| PRIMARY Severity of Adverse Events (AE's) |
1; 0; 0; 0; 1; 0 | — |
| SECONDARY Proportion of Subjects Achieving Renal Response From Baseline to Day 85 |
0; 1 | — |
| SECONDARY Proportion of Subjects Achieving a Partial Renal Response From Baseline to Day 85 |
0.29; 0.71 | — |
| SECONDARY Change From Baseline to Day 85 in Vital Signs |
1.3 | — |
| SECONDARY Change in Systolic Blood Pressure From Baseline to Day 85 |
-1.4 | — |
| SECONDARY Change in Diastolic Blood Pressure From Baseline to Day 85 |
2.1 | — |
| SECONDARY Change in Temperature From Baseline to Day 85 |
0.2 | — |
| SECONDARY Change in Weight From Baseline to Day 85 |
-0.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT02384317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.