A Study of CCX140-B in Subjects With FSGS

Completed · Phase 2 · Has a placebo group

Conditions studied: FSGS, Focal Segmental Glomerulosclerosis, Glomerulosclerosis

In brief

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with FSGS to be conducted in the North America, Europe and Australia

Key facts

Study ID

NCT03536754

Run by

Amgen

People needed

46

Starts

2018-05-17

Expected to finish

2020-02-19

Last updated by the study team

2025-03-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged 18-75
• UPCR ≥ 1 g protein/g creatinine (or at 113 mg.mmol) at screening
• Diagnosis of FSGS based on renal biopsy or high risk genetic variant
• Diagnosis of one of primary FSGS based on characteristic histopathology, medical history and clinical course or FSGS secondary to genetic variants associated with increased risk or severity.
• Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2
• Clinical stable blood pressure not to exceed 145/95 mmHg
• RAAS blockers must be stable for at least 4 weeks prior to screening and projected to remain stable through week 12, unless adjustments are required for management of hypertension.
• Immunosuppressive or immunomodulatory therapy must be stable for at least 4 weeks prior to screening and projected to remain stable through study week 12
• Glucocorticoids must be stable for at least 4 weeks prior to screening and projected to remain stable through study week 12.
• Both genders of childbearing potential must agree to use adequate contraception during and for at least 3 months after the last dose of study drug.
• Subjects must be willing and able to give written Informed Consent and to comply with protocol requirements.
• Subjects must be judged to be otherwise fit for the study by the Investigator. -

You may not qualify if…

• Pregnant or nursing
• History of organ transplantation
• On an organ transplant waiting list or anticipated organ transplant within 6 months of screening
• Anti-CD20 monoclonal antibodies within 20 months of screening are exclusionary. Subjects that used anti CD20 monoclonal antibodies prior to week 20 are allowed with confirmed recovery of CD20+ B cell population to within normal range
• Plasmapheresis within 12 weeks of screening
• BMI ≥40
• Participation in any clinical study of an investigational product within 12 weeks or 5 half-lives of screening
• Currently on dialysis or likely to require dialysis during the blinded treatment phase of the study.
• History or presence of any form of cancer within 5 years of screening except excised basal cell or squamous cell carcinoma or carcinoma in situ such as cervical or breast carcinoma in situ that has been excised or completed resected without evidence or recurrence.
• Positive HBV, HCV, or HIV viral screening test. Subjects who have received highly effective therapy for HCV demonstrated to have negative viral titers for at least 6 months following discontinuation of treatment, will be considered to have a negative HCV screening test
• Renal disease associated with disorders other than FSGS that is active or has significant risk of progressing during the course of the study.
• Disorders that are associated with FSGS lesions.
• Evidence of tuberculosis.
• Evidence of hepatic disease with the exception that isolated INR elevation in the absence of other significant liver enzyme abnormalities is explained by anticoagulant therapy, (e.g. warfarin)
• Hematologic abnormalities as follows: Hb <8 g/dL, platelets <50,000, ANC <1000 cells/µL) at baseline.
• QTcF greater than 450 msec.
• History of alcohol or illicit drug abuse or of lithium, pamidronate and interferon. Recreational use of cannabis is not excluded where legal.
• History of gastrointestinal conditions that may interfere with study medication compliance.
• Known hypersensitivity to CCX140-B or inactive ingredients of the CCX140-B tablets (including microcrystalline cellulose, starch, crospovidone, magnesium stearate, or silicon dioxide).
• History or presence of systemic disorder other than FSGS that requires, or is expected to require, systemic glucocorticoids or immune modulators during the study; topical or inhaled glucocorticoids and immune modulators are not excluded.
• History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation.
• Subjects taking strong CYP3A4 inducers or strong CYP3A4 inhibitors within two weeks prior to screening.
• Subjects taking lithium or interferon; subjects taking non-steroidal anti-inflammatory agents (NSAIDS) chronically (intermittent, i.e. occasional NSAIDS for pain or fever is discouraged, but is not excluded).

Where it is running

• AKDHC — Phoenix, Arizona, United States
• Los Angeles Biomedical Research Institute — Torrance, California, United States
• Northwest Louisiana Nephrology — Shreveport, Louisiana, United States
• MGH — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• East Carolina University — Greenville, North Carolina, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• University of Texas Health Sciences Center — Houston, Texas, United States
• Utah Kidney Research Institute — Salt Lake City, Utah, United States
• Monash Medical Centre — Clayton, Victoria, Australia
• Austin Health — Heidelberg, Victoria, Australia
• Royal Melbourne Hospital — Parkville, Australia
• St. Josephs Healthcare - Hamilton — Hamilton, Ontario, Canada
• Sunnybrook Health Sciences Centre (Odette Cancer Center) — Toronto, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• CISSS de la Monteregie-Centre - Hopital Charles LeMoyne — Greenfield Park, Quebec, Canada
• CHU Bordeaux- Hospital Pellegrin — Bordeaux, France
• CHU Henri Mondor — Créteil, France
• CHU de Grenoble — Grenoble, France
• APHM - Hopital de la Conception — Marseille, France
• Hopitaux Prives de Metz — Metz, France
• Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII — Bergamo, Italy
• IRCCS Azienda Ospedaliera Universitaria San Martino IST — Genova, Italy
• Presidio Ospedaliero di Montichiari-A.O. Spedali Civili di Brescia — Montichiari, Italy
• Fondazione S. Maugeri IRCCS — Pavia, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.