Trial Outcomes & Findings for Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade (NCT NCT02384317)
NCT ID: NCT02384317
Last Updated: 2025-03-13
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Week -8 to -1 (Run-in period) and Week 1 to 12 (treatment period)
Results posted on
2025-03-13
Participant Flow
Screening took place for 14 days. Screening was following by a combined renin-angiotensin-aldosterone system (RAAS) titration (up to 4 weeks) plus run-in period (8 weeks) with an additional up to 7-day eligibility confirmation.
Participant milestones
| Measure |
CCX168
Modified Intent-to-Treatment (mITT) Population included all subjects who received at least one dose of study drug and who had at least one post baseline urinary PCR assessment.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade
Baseline characteristics by cohort
| Measure |
Overall Study
n=7 Participants
Safety Population included of all subjects who received at least one dose of study drug.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.1 years
STANDARD_DEVIATION 13.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
3 Participants
n=5 Participants
|
|
BMI
|
30.05 kg/m²
STANDARD_DEVIATION 8.29 • n=5 Participants
|
|
Mean time since diagnosis of IgAN
|
17.3 month
n=5 Participants
|
|
PCR
|
1906.84 mg/g
n=5 Participants
|
|
ACR
|
1528.42 mg/g
n=5 Participants
|
|
eGFR
|
65.89 mL/min/1.73m²
n=5 Participants
|
|
MCP-1 to Creatinine ratio
|
577.44 pg/mg crea
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
CCX168
n=7 Participants
Modified Intent-to-Treatment (mITT) Population included all subjects who received at least one dose of study drug and who had at least one post baseline urinary PCR assessment.
|
8-week Run-in Period
n=7 Participants
8-week RAAS run-in period
|
12-week Treatment Period
n=7 Participants
12-week CCX168 treatment period
|
|---|---|---|---|
|
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 mg/g/week
Interval -133.6 to 128.7
|
15.3 mg/g/week
Interval -87.3 to 117.9
|
-23.9 mg/g/week
Interval -195.0 to 147.2
|
PRIMARY outcome
Timeframe: Day 0 - Day 169 (throughout the trial)Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Outcome measures
| Measure |
CCX168
n=7 Participants
Modified Intent-to-Treatment (mITT) Population included all subjects who received at least one dose of study drug and who had at least one post baseline urinary PCR assessment.
|
8-week Run-in Period
8-week RAAS run-in period
|
12-week Treatment Period
12-week CCX168 treatment period
|
|---|---|---|---|
|
Number of Participants With AE's
Subjects who had any AE
|
7 Participants
|
—
|
—
|
|
Number of Participants With AE's
Subjects who had an SAE
|
1 Participants
|
—
|
—
|
|
Number of Participants With AE's
Subjects who had an AE possibly related
|
5 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 - Day 169 (throughout the trial)Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Outcome measures
| Measure |
CCX168
n=7 Participants
Modified Intent-to-Treatment (mITT) Population included all subjects who received at least one dose of study drug and who had at least one post baseline urinary PCR assessment.
|
8-week Run-in Period
8-week RAAS run-in period
|
12-week Treatment Period
12-week CCX168 treatment period
|
|---|---|---|---|
|
Severity of Adverse Events (AE's)
Deaths
|
0 Number of AEs
|
—
|
—
|
|
Severity of Adverse Events (AE's)
AE leading to interruption of treatment
|
1 Number of AEs
|
—
|
—
|
|
Severity of Adverse Events (AE's)
AE leading to permanent discontinuation of study
|
0 Number of AEs
|
—
|
—
|
|
Severity of Adverse Events (AE's)
Withdrawals due to AE
|
0 Number of AEs
|
—
|
—
|
|
Severity of Adverse Events (AE's)
AE of grade 3 ≥
|
1 Number of AEs
|
—
|
—
|
|
Severity of Adverse Events (AE's)
Related AE grade 3≥
|
0 Number of AEs
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 85Renal 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.
Outcome measures
| Measure |
CCX168
n=7 Participants
Modified Intent-to-Treatment (mITT) Population included all subjects who received at least one dose of study drug and who had at least one post baseline urinary PCR assessment.
|
8-week Run-in Period
8-week RAAS run-in period
|
12-week Treatment Period
12-week CCX168 treatment period
|
|---|---|---|---|
|
Proportion of Subjects Achieving Renal Response From Baseline to Day 85
Patients with a renal response by Day 85
|
0 proportion of participants
|
—
|
—
|
|
Proportion of Subjects Achieving Renal Response From Baseline to Day 85
Patients with no renal response by Day 85
|
1 proportion of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and Day 85A 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.
Outcome measures
| Measure |
CCX168
n=7 Participants
Modified Intent-to-Treatment (mITT) Population included all subjects who received at least one dose of study drug and who had at least one post baseline urinary PCR assessment.
|
8-week Run-in Period
8-week RAAS run-in period
|
12-week Treatment Period
12-week CCX168 treatment period
|
|---|---|---|---|
|
Proportion of Subjects Achieving a Partial Renal Response From Baseline to Day 85
Patients with a partial renal response at day 85
|
0.29 proportion of participants
|
—
|
—
|
|
Proportion of Subjects Achieving a Partial Renal Response From Baseline to Day 85
Patients with no partial renal response at day 85
|
0.71 proportion of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to day 85Outcome measures
| Measure |
CCX168
n=7 Participants
Modified Intent-to-Treatment (mITT) Population included all subjects who received at least one dose of study drug and who had at least one post baseline urinary PCR assessment.
|
8-week Run-in Period
8-week RAAS run-in period
|
12-week Treatment Period
12-week CCX168 treatment period
|
|---|---|---|---|
|
Change From Baseline to Day 85 in Vital Signs
|
1.3 beats per minute
Standard Deviation 8.56
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to day 85Outcome measures
| Measure |
CCX168
n=7 Participants
Modified Intent-to-Treatment (mITT) Population included all subjects who received at least one dose of study drug and who had at least one post baseline urinary PCR assessment.
|
8-week Run-in Period
8-week RAAS run-in period
|
12-week Treatment Period
12-week CCX168 treatment period
|
|---|---|---|---|
|
Change in Systolic Blood Pressure From Baseline to Day 85
|
-1.4 mmHg
Standard Deviation 12.11
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to day 85Outcome measures
| Measure |
CCX168
n=7 Participants
Modified Intent-to-Treatment (mITT) Population included all subjects who received at least one dose of study drug and who had at least one post baseline urinary PCR assessment.
|
8-week Run-in Period
8-week RAAS run-in period
|
12-week Treatment Period
12-week CCX168 treatment period
|
|---|---|---|---|
|
Change in Diastolic Blood Pressure From Baseline to Day 85
|
2.1 mmHg
Standard Deviation 8.45
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to day 85Outcome measures
| Measure |
CCX168
n=7 Participants
Modified Intent-to-Treatment (mITT) Population included all subjects who received at least one dose of study drug and who had at least one post baseline urinary PCR assessment.
|
8-week Run-in Period
8-week RAAS run-in period
|
12-week Treatment Period
12-week CCX168 treatment period
|
|---|---|---|---|
|
Change in Temperature From Baseline to Day 85
|
0.2 C
Standard Deviation 0.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to day 85Outcome measures
| Measure |
CCX168
n=7 Participants
Modified Intent-to-Treatment (mITT) Population included all subjects who received at least one dose of study drug and who had at least one post baseline urinary PCR assessment.
|
8-week Run-in Period
8-week RAAS run-in period
|
12-week Treatment Period
12-week CCX168 treatment period
|
|---|---|---|---|
|
Change in Weight From Baseline to Day 85
|
-0.6 kg
Standard Deviation 2.39
|
—
|
—
|
Adverse Events
Safety Population
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Population
n=7 participants at risk
Safety population included all subjects who received any CCX168
|
|---|---|
|
Cardiac disorders
Angina unstable
|
14.3%
1/7 • From Baseline up to 169 days
|
Other adverse events
| Measure |
Safety Population
n=7 participants at risk
Safety population included all subjects who received any CCX168
|
|---|---|
|
Nervous system disorders
Headache
|
42.9%
3/7 • Number of events 3 • From Baseline up to 169 days
|
|
Infections and infestations
Nasopharyngitis
|
42.9%
3/7 • Number of events 3 • From Baseline up to 169 days
|
|
General disorders
Peripheral swelling
|
42.9%
3/7 • Number of events 3 • From Baseline up to 169 days
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
2/7 • Number of events 3 • From Baseline up to 169 days
|
|
Investigations
Blood creatine phosphokinase increased
|
28.6%
2/7 • Number of events 3 • From Baseline up to 169 days
|
|
Gastrointestinal disorders
Diarrhea
|
28.6%
2/7 • Number of events 3 • From Baseline up to 169 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
28.6%
2/7 • Number of events 4 • From Baseline up to 169 days
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 4 • From Baseline up to 169 days
|
|
Infections and infestations
Urinary tract infection
|
28.6%
2/7 • Number of events 2 • From Baseline up to 169 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Investigations
Blood creatinine increased
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Investigations
Blood lactate dehydrogenase increased
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Investigations
Blood thyroid stimulating hormone increased
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Renal and urinary disorders
Dysuria
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Investigations
Eosinophil count increased
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
General disorders
Fatigue
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Gastrointestinal disorders
Inguinal hernia
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
General disorders
Localized oedema
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Nervous system disorders
Migraine
|
14.3%
1/7 • Number of events 2 • From Baseline up to 169 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
General disorders
Oedema peripheral
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Infections and infestations
Parotitis
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Renal and urinary disorders
Polyuria
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Infections and infestations
Rhinovirus infection
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Ear and labyrinth disorders
Vertigo
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
|
Injury, poisoning and procedural complications
Wound
|
14.3%
1/7 • Number of events 1 • From Baseline up to 169 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place