18 and older, any sex, with Immunoglobulin A Nephropathy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Slope of First Morning Urinary PCR From the 8-week RAAS Blocker run-in Period to the 12-week CCX168 Treatment PeriodPrimary· Week -8 to -1 (Run-in period) and Week 1 to 12 (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
Group
Value
95% CI
CCX168
-2.4
-133.6 – 128.7
8-week Run-in Period
15.3
-87.3 – 117.9
12-week Treatment Period
-23.9
-195.0 – 147.2
Number of Participants With AE'sPrimary· Day 0 - Day 169 (throughout the trial)
Proportion of Subjects Achieving Renal Response From Baseline to Day 85Secondary· Baseline and 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.
Patients with a renal response by Day 85
Group
Value
95% CI
CCX168
0
Patients with no renal response by Day 85
Group
Value
95% CI
CCX168
1
Proportion of Subjects Achieving a Partial Renal Response From Baseline to Day 85Secondary· Baseline and 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.
Patients with a partial renal response at day 85
Group
Value
95% CI
CCX168
0.29
Patients with no partial renal response at day 85
Group
Value
95% CI
CCX168
0.71
Change From Baseline to Day 85 in Vital SignsSecondary· Baseline to day 85
Group
Value
95% CI
Safety Population
1.3
± 8.56
Severity of Adverse Events (AE's)Primary· Day 0 - Day 169 (throughout the trial)
Change in Systolic Blood Pressure From Baseline to Day 85Secondary· Baseline to day 85
Group
Value
95% CI
Safety Population
-1.4
± 12.11
Change in Diastolic Blood Pressure From Baseline to Day 85Secondary· Baseline to day 85
Group
Value
95% CI
Safety Population
2.1
± 8.45
Change in Temperature From Baseline to Day 85Secondary· Baseline to day 85
Group
Value
95% CI
Safety Population
0.2
± 0.68
Change in Weight From Baseline to Day 85Secondary· Baseline to day 85
Group
Value
95% CI
Safety Population
-0.6
± 2.39
Adverse events — posted to ClinicalTrials.gov
Time frame: From Baseline up to 169 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05988008 — A Study of CCX168 in Japanese and Caucasian Healthy Adult Males
· Phase 1
· completed
NCT06004947 — A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications
· Phase 1
· completed
NCT05988021 — A Study in Healthy Volunteers to Evaluate the Pharmacokinetic Food Effect and Cardiac Safety of CCX168
· Phase 1
· completed
NCT05984251 — A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX168 in Healthy Participants
· Phase 1
· completed
Other recruiting trials for Immunoglobulin A Nephropathy
Currently open trials in the same condition.
NCT07024563 — Study of Ravulizumab in Pediatric Participants With Primary IgAN
· Phase 3
· recruiting
NCT06952426 — A Mobile App-Based Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the
· recruiting
NCT06797518 — Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN
· Phase 2
· recruiting
NCT06564142 — Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
· Phase 3
· active not recruiting
NCT06291376 — Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
· Phase 3
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 13 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02384317.