A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome

February 25, 2025 updated by: Amgen

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90502
        • Los Angeles Biomedical Research Institute
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Northwest Louisiana Nephrology
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota
    • Utah
      • Salt Lake City, Utah, United States, 84115
        • Utah Kidney Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subjects aged 18 years and older
  2. 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
  3. Urinary total protein:creatinine ratio (UPCR) ≥ 3.5 g protein/g creatinine at screening

Exclusion Criteria:

  1. Pregnant or nursing
  2. History of organ transplantation, including renal transplantation
  3. Currently on an organ transplant waiting list or there's a reasonable possibility of getting an organ transplant within 6 months of screening
  4. Histological FSGS subtype of collapsing variant
  5. 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.
  6. 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.
  7. Body Mass Index (BMI) ≥ 40

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequential
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.
Drug: CCX140-B
Orally administered tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment
Time Frame: Baseline to week 12

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
Baseline to week 12
Proportion of Subjects With Achievement of Complete Remission During the Treatment Period
Time Frame: Baseline to week 52
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.
Baseline to week 52
Time Taken of Subjects to Achieve Complete Remission During the Treatment Period
Time Frame: Baseline to week 52
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.
Baseline to week 52
Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time
Time Frame: Baseline to week 12 and week 52
Mean change from baseline in urinary protein:creatinine ratio (UPCR) over time.
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
Partial remission is defined as reduction from baseline by ≥50% in UPCR, reduction in UPCR to a level that was <3.5 g/g.
Baseline to week 52
Time to Rescue Therapy
Time Frame: Baseline to week 52
Based on Investigator or physician initiation of glucocorticoids or new immunosuppressive agents or new major treatment modalities (e.g. plasmapheresis, dialysis)
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
eGFR-Estimated Glomerular Filtration Rate;CKD-EPI=Chronic Kidney Disease Epidemiology Collaboration
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
CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate
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
CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular filtration rate;
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
MDRD = Modification of Diet in Renal Disease. The mean eGFR (using the MDRD Creatinine equation) change from baseline to Week 12 and Week 52
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

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).
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

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.
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
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
Baseline to Day 57

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes from baseline in EKG values
Time Frame: Baseline to each subsequent clinic visit through week 52
Triplicate EKGs assessed for any clinically significant abnormalities as determined by the relevant PIs evaluation
Baseline to each subsequent clinic visit through week 52
Changes from baseline in blood pressure
Time Frame: Baseline to each subsequent clinic visit through week 52
Assessment of systolic and diastolic BP changes from baseline
Baseline to each subsequent clinic visit through week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL012_140
  • LUMINA-2 (Other Identifier: Chemocentryx)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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