Immunoglobulin A NephropathyPhase 2NCT02384317

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

A Phase 2 study testing CCX168 in people with Immunoglobulin A Nephropathy, run by Amgen at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Immunoglobulin A Nephropathy
What is being tested?: CCX168
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 6 sitesin 2 countries
Study dates: 27 Mar 2015to 1 Jun 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

United States5 sites

Study site
Chapel Hill, North Carolina
Study site
Columbus, Ohio
Study site
Palo Alto, California
Study site
Reno, Nevada
Study site
San Francisco, California

Other trials in United States

Sweden1 site

Study site
Stockholm

Other trials in Sweden

About this study

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

Read the detailed description

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Conditions: Immunoglobulin A Nephropathy
Being tested: CCX168
Medical subject headings: Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CCX168Drug
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.

Study groups in NCT02384317
Study group	Role	What they receive
CCX168 (Avacopan)	Experimental	CCX168 (Avacopan) plus stable dose of RAAS blocker Receives: Drug: CCX168

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Week -8 to -1 (Run-in period) and Week 1 to 12 (treatment period)
Number of Participants With AE's
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Measured: Day 0 - Day 169 (throughout the trial)
Severity of Adverse Events (AE's)
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Measured: Day 0 - Day 169 (throughout the trial)

Secondary outcomes (7)

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.
Measured: Baseline and Day 85
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.
Measured: Baseline and Day 85
Change From Baseline to Day 85 in Vital Signs
Measured: Baseline to day 85
Change in Systolic Blood Pressure From Baseline to Day 85
Measured: Baseline to day 85
Change in Diastolic Blood Pressure From Baseline to Day 85
Measured: Baseline to day 85
Change in Temperature From Baseline to Day 85
Measured: Baseline to day 85
Change in Weight From Baseline to Day 85
Measured: Baseline to day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 20151 Jun 2018

First posted10 Mar 2015 (estimated)
Study start27 Mar 2015
Primary completion13 Sep 2015
Study completion1 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Immunoglobulin A NephropathyStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02384317
Sponsor's protocol ID: CL005_168
Other IDs: 2014-003402-33, 2014
Status last verified: Mar 2025
First submitted: 11 Feb 2015
Last updated: 13 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 2
A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
Atherosclerosis, Cardiovascular Disease

All Immunoglobulin A Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02384317
Acronym / sponsor ID: CL005_168
Conditions: Immunoglobulin A Nephropathy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 27 Mar 2015 (actual)
Primary completion: 13 Sep 2015 (actual)
Study completion: 1 Jun 2018 (actual)
First posted: 10 Mar 2015 (estimated)
Results: Posted 1 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CCX168 (Avacopan)	Experimental	Drug: CCX168CCX168 (Avacopan) plus stable dose of RAAS blocker

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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 (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CCX168CCX168 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.	Drug	CCX168 (Avacopan)

Primary outcome

Change in Slope of First Morning Urinary PCR From the 8-week RAAS Blocker run-in Period to the 12-week CCX168 Treatment Period
Time frame: 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
Number of Participants With AE's
Time frame: Day 0 - Day 169 (throughout the trial)
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Severity of Adverse Events (AE's)
Time frame: Day 0 - Day 169 (throughout the trial)
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)

7 secondary outcomes

Proportion of Subjects Achieving Renal Response From Baseline to Day 85
Time frame: Baseline and Day 85
Proportion of Subjects Achieving a Partial Renal Response From Baseline to Day 85
Time frame: Baseline and Day 85
Change From Baseline to Day 85 in Vital Signs
Time frame: Baseline to day 85
Change in Systolic Blood Pressure From Baseline to Day 85
Time frame: Baseline to day 85
Change in Diastolic Blood Pressure From Baseline to Day 85
Time frame: Baseline to day 85
Change in Temperature From Baseline to Day 85
Time frame: Baseline to day 85
Change in Weight From Baseline to Day 85
Time frame: Baseline to day 85

Results and safety

Results posted to the registry on 1 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CCX168	7	7

Primary outcome: Change in Slope of First Morning Urinary PCR From the 8-week RAAS Blocker run-in Period to the 12-week CCX168 Treatment Period

Time frame: Week -8 to -1 (Run-in period) and Week 1 to 12 (treatment period). Mean (95% Confidence Interval). Unit: mg/g/week

Measure	CCX168 n = 7	8-week Run-in Period n = 7	12-week Treatment Period n = 7
Value	-2.4 (-133.6 to 128.7)	15.3 (-87.3 to 117.9)	-23.9 (-195.0 to 147.2)

8-week Run-in Period vs 12-week Treatment Period: Slope: -2.4 (95% CI -133.6 to 128.7), p = 0.965, Random coefficients regression

Primary outcome: Number of Participants With AE's

Time frame: Day 0 - Day 169 (throughout the trial). Count of participants. Unit: Participants

Measure	Safety Population n = 7
Subjects who had any AE	7
Subjects who had an SAE	1
Subjects who had an AE possibly related	5

Primary outcome: Severity of Adverse Events (AE's)

Time frame: Day 0 - Day 169 (throughout the trial). Number. Unit: Number of AEs

Measure	Safety Population n = 7
AE leading to interruption of treatment	1
AE leading to permanent discontinuation of study	0
Withdrawals due to AE	0
Deaths	0
AE of grade 3 ≥	1
Related AE grade 3≥	0

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline up to 169 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Population	1 of 7 (14.3%)	7 of 7 (100%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Related trials for Immunoglobulin A Nephropathy

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 2
A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event
Atherosclerosis, Cardiovascular Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CCX168 in people with Immunoglobulin A Nephropathy, run by Amgen at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Week -8 to -1 (Run-in period) and Week 1 to 12 (treatment period)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02384317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.