ChemoCentryx CL140FSGS
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS)
IRAS ID
245893
Contact name
Ashraf Ishak Mikhail
Contact email
Sponsor organisation
ChemoCentryx, Inc.
Eudract number
2017-003021-15
Duration of Study in the UK
1 years, 9 months, 0 days
Research summary
CCX140-B is an investigational medication being studied to learn if it is safe and effective for the treatment of Focul segmental glomerulosclerosis (FSGS). Patients with FSGS lesions may present with nephrotic syndrome or with sub-clinical elevations of urinary protein or serum creatinine. CCX140-B is being developed by ChemoCentryx, Inc.
This trial is a double-blind, placebo-controlled, dose ranging study in adult patients with primary or genetic FSGS and elevated urinary protein excretion. Patients will be randomised 1:1:1:1 to receive Placebo or CCX140-B
administered as 5mg once daily, 10 mg twice daily, or 15 mg twice daily. The study consists of two 12 week treatment periods. The initial treatment period is double-blind and placebo-controlled while the 12-week continuation treatment period is open label. During the continuation treatment period eligible patients will continue
to receive up to 15 mg CCX140-B twice daily. Approximately 40 patients with FSGS that have been confirmed by kidney biopsy will be enrolled in this study at approximately 45 study centres globally. Approximately 4 participants will be enrolled in the United Kingdom.The primary safety objective of this study is to evaluate the safety and tolerability of CCX140-B in participants with FSGS with proteinuria.
The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary protein excretion in participants with FSGS, as assessed by change from baseline in the urine protein to creatinine ratio (UPCR).REC name
Wales REC 1
REC reference
18/WA/0262
Date of REC Opinion
23 Oct 2018
REC opinion
Further Information Favourable Opinion