Focal Segmental GlomerulosclerosisPhase 2NCT03703908
A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome
A Phase 2 study testing CCX140-B in people with Focal Segmental Glomerulosclerosis, run by Amgen at 5 sites in United States.
Trial summary
An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary FSGS and Nephrotic Syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Segmental Glomerulosclerosis
- What is being tested?
- CCX140-B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2018to 24 Jun 2020
- 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
- Male or female subjects aged 18 years and older
- Primary FSGS based on renal biopsy findings consistent with FSGS and based on presentation of histopathology, medical history and clinical course OR subjects with genetic risk factors with presentations that are otherwise consistent with primary FSGS
- Urinary total protein:creatinine ratio (UPCR) ≥ 3.5 g protein/g creatinine at screening
Who cannot join
- Pregnant or nursing
- History of organ transplantation, including renal transplantation
- Currently on an organ transplant waiting list or there's a reasonable possibility of getting an organ transplant within 6 months of screening
- Histological FSGS subtype of collapsing variant
- Subjects who initiated, discontinued or changed dose of anti-CD20 monoclonal antibodies within 16 weeks (4 months) prior to screening are excluded. Subjects who initiated treatment with anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening are permitted if deemed safe by the investigator and only if they intend to remain on continued, unchanged therapy at a dosing interval that has been documented to achieve continuous B cell depletion for the given patient.
- Subjects who discontinued Rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening without confirmed recovery of CD20+ B cell population to within normal range are excluded. Subjects who discontinued rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening with confirmed recovery of CD20+ B cell population to within normal range are permitted in the study. UPCR and other urine protein assessments up to 1 year prior to screening (if available) that were performed in these patients as part of the clinical routine should be recorded in the medical history.
- Body Mass Index (BMI) ≥ 40
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Minnesota
Minneapolis, Minnesota, 55414
Utah Kidney Research Institute
Salt Lake City, Utah, 84115
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101
Los Angeles Biomedical Research Institute
Torrance, California, 90502
About this study
Official title: An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome
An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary FSGS and Nephrotic Syndrome
Read the detailed description
An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome. The aim of this study is to explore the effect of CCX140-B, a selective antagonist of C-C chemokine receptor type 2, on proteinuria in subjects with FSGS.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
- Conditions
- Focal Segmental Glomerulosclerosis
- Being tested
- CCX140-B
- Keywords
- FSGS, Glomerulosclerosis, Proteinuria
- Medical subject headings
- Glomerulosclerosis, Focal Segmental, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCX140-BDrug
Orally administered tablet
| Study group | Role | What they receive |
|---|---|---|
| Sequential | Experimental | All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily. Receives: Drug: CCX140-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20%
Number of subjects with a reduction in Urine Protein to Creatinine Ratio (UPCR) of at least 20% , i.e., ≥20%, by Week 12.
Measured: Baseline to week 12
Secondary outcomes (13)
Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment
Partial and complete remission were defined as follows:
Partial remission (included all of the following):
- Reduction from baseline by ≥50% in urine protein:creatinine ratio (UPCR)
- Reduction in UPCR to a level that was <3.5 g/g
- Subject could not have been a treatment failure
Complete remission (included all of the following):
- Reduction in UPCR to <0.3 g/g
- Serum albumin within normal range
- For subjects with abnormal serum creatinine levels at baseline, return to normal levels
- For subjects with normal serum creatinine levels at baseline, final value within 20% of baseline levels
- Subject could not have been a treatment failure
Measured: Baseline to week 12
Proportion of Subjects With Achievement of Complete Remission During the Treatment Period
Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to <0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels.
Measured: Baseline to week 52
Time Taken of Subjects to Achieve Complete Remission During the Treatment Period
Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to <0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels.
Measured: Baseline to week 52
Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time
Mean change from baseline in urinary protein:creatinine ratio (UPCR) over time.
Measured: Baseline to week 12 and week 52
Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period
Partial remission is defined as reduction from baseline by ≥50% in UPCR, reduction in UPCR to a level that was <3.5 g/g.
Measured: Baseline to week 52
Time to Rescue Therapy
Based on Investigator or physician initiation of glucocorticoids or new immunosuppressive agents or new major treatment modalities (e.g. plasmapheresis, dialysis)
Measured: Baseline to week 52
Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time
eGFR-Estimated Glomerular Filtration Rate;CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration
Measured: Baseline to Week 12 and Week 52
Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time
CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate
Measured: Baseline to Week 12 and Week 52
Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time
CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate;
Measured: Baseline to Week 12 and Week 52
Mean Change From Baseline for the MDRD Creatinine Equation Over Time
MDRD = Modification of Diet in Renal Disease. The mean eGFR (using the MDRD Creatinine equation) change from baseline to Week 12 and Week 52
Measured: Baseline to Week 12 and Week 52
Effect of CCX140-B Treatment on Quality of Life Endpoint SF-36V2
Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoints SF-36V2 for the overall trial
SF-36v2: Medical Outcomes Survey Short Form-36 version 2.
SF-36v2 measures each of the following eight health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Scores on each item are summed and averaged. The SF-36v2 component domain scores range from 0 (worst health) to 100 (best health).
Measured: Baseline to Week 52
Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the Overall Trial
Summary of the Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the overall trial EQ-5D-5L: EuroQuality of Life-5 Domains-5 Levels. The EQ-5D-5L consists of : the EQ-5D descriptive system. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
The scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.
Measured: Baseline to Week 12 and Week 52
Changes to Laboratory Parameters Related to Renal Function Including Serum Albumin, Creatinine, Cystatin C, Urinary Albumin:Creatinine Ratio, Total 24-hour Protein Excretion During the Trial
Changes to laboratory parameters related to renal function including serum albumin, creatinine, cystatin C, urinary albumin:creatinine ratio, total 24-hour protein excretion during the trial
Measured: Baseline to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Oct 2018
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Why it stopped: Program not advancing
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 Focal Segmental GlomerulosclerosisStudies 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
- Sequential
- Model description
- Open-Label, Intra-Subject, Dose Escalation
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703908
- Sponsor's protocol ID
- CL012_140
- Other IDs
- LUMINA-2
- Status last verified
- Feb 2025
- First submitted
- 24 Jul 2018
- Last updated
- 17 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT03703908
- Acronym / sponsor ID
- CL012_140
- Conditions
- Focal Segmental Glomerulosclerosis
- Keywords
- FSGS, Glomerulosclerosis, Proteinuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Program not advancing
- Enrolment
- 5 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Posted 6 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary FSGS and Nephrotic Syndrome
Detailed description
An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome. The aim of this study is to explore the effect of CCX140-B, a selective antagonist of C-C chemokine receptor type 2, on proteinuria in subjects with FSGS.
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label, Intra-Subject, Dose Escalation
| Arm | Type | Receives |
|---|---|---|
| Sequential | Experimental | Drug: CCX140-BAll enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects aged 18 years and older
- Primary FSGS based on renal biopsy findings consistent with FSGS and based on presentation of histopathology, medical history and clinical course OR subjects with genetic risk factors with presentations that are otherwise consistent with primary FSGS
- Urinary total protein:creatinine ratio (UPCR) ≥ 3.5 g protein/g creatinine at screening
Key exclusion criteria (7 listed)
- Pregnant or nursing
- History of organ transplantation, including renal transplantation
- Currently on an organ transplant waiting list or there's a reasonable possibility of getting an organ transplant within 6 months of screening
- Histological FSGS subtype of collapsing variant
- Subjects who initiated, discontinued or changed dose of anti-CD20 monoclonal antibodies within 16 weeks (4 months) prior to screening are excluded. Subjects who initiated treatment with anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening are permitted if deemed safe by the investigator and only if they intend to remain on continued, unchanged therapy at a dosing interval that has been documented to achieve continuous B cell depletion for the given patient.
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 |
|---|---|---|
| CCX140-BOrally administered tablet | Drug | Sequential |
Primary outcome
The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20%
Time frame: Baseline to week 12
Number of subjects with a reduction in Urine Protein to Creatinine Ratio (UPCR) of at least 20% , i.e., ≥20%, by Week 12.
13 secondary outcomes
Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment
Time frame: Baseline to week 12
Proportion of Subjects With Achievement of Complete Remission During the Treatment Period
Time frame: Baseline to week 52
Time Taken of Subjects to Achieve Complete Remission During the Treatment Period
Time frame: Baseline to week 52
Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time
Time frame: Baseline to week 12 and week 52
Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period
Time frame: Baseline to week 52
Time to Rescue Therapy
Time frame: Baseline to week 52
Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time
Time frame: Baseline to Week 12 and Week 52
Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time
Time frame: Baseline to Week 12 and Week 52
Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time
Time frame: Baseline to Week 12 and Week 52
Mean Change From Baseline for the MDRD Creatinine Equation Over Time
Time frame: Baseline to Week 12 and Week 52
Effect of CCX140-B Treatment on Quality of Life Endpoint SF-36V2
Time frame: Baseline to Week 52
Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the Overall Trial
Time frame: Baseline to Week 12 and Week 52
Changes to Laboratory Parameters Related to Renal Function Including Serum Albumin, Creatinine, Cystatin C, Urinary Albumin:Creatinine Ratio, Total 24-hour Protein Excretion During the Trial
Time frame: Baseline to Day 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CCX140-B in people with Focal Segmental Glomerulosclerosis, run by Amgen at 5 sites in United States.
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 7 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: stopped early, as of the sponsor's last update on 17 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 5 sites in United States. 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 6 Feb 2024). 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?
The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20% (time frame: Baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2025.