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

NCT03703908 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: CL012_140LUMINA-2
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 5

Brief Summary

An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary FSGS and Nephrotic Syndrome

Conditions

Focal Segmental Glomerulosclerosis

Keywords

FSGS; Glomerulosclerosis; Proteinuria

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to week 12

Secondary Outcomes (13)

• Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment

  Baseline to week 12

• Proportion of Subjects With Achievement of Complete Remission During the Treatment Period

  Baseline to week 52

• Time Taken of Subjects to Achieve Complete Remission During the Treatment Period

  Baseline to week 52

• Change From Baseline in Urine 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

  Baseline to week 52

Study Arms (1)

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.

Drug: CCX140-B

Interventions

CCX140-B DRUG

Orally administered tablet

Sequential

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (5)

Los Angeles Biomedical Research Institute

Torrance, California, 90502, United States

Location

Northwest Louisiana Nephrology

Shreveport, Louisiana, 71101, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Utah Kidney Research Institute

Salt Lake City, Utah, 84115, United States

Location

MeSH Terms

Conditions

Glomerulosclerosis, Focal Segmental; Proteinuria

Interventions

CCX140-B

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The CL012\_140 study was terminated early due to lack of efficacy in another study, CL011\_140, investigating the use of CCX140-B.

Results Point of Contact

• Title: Study Director
• Organization: ChemoCentryx

clinicaltrials@chemocentryx.com

650-210-2900

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-Label, Intra-Subject, Dose Escalation

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: October 12, 2018
• Study Start: October 1, 2018
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: March 17, 2025
• Results First Posted: February 6, 2024

Record last verified: 2025-02

Locations

US (5)