FALCON
Research type
Research Study
Full title
A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease
IRAS ID
264501
Contact name
Matthew Hall
Contact email
Sponsor organisation
Reata Pharmaceuticals, Inc.
Eudract number
2018-004651-20
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
140817, US IND Number
Duration of Study in the UK
3 years, 1 months, 12 days
Research summary
Summary of Research
Researchers want to find out if the drug bardoxolone methyl can improve the disease ADPKD (autosomal dominant polycystic kidney disease).
Bardoxolone methyl is an investigational (experimental) drug that is being tested and is currently not approved by any regulatory agency for sale. It is a semi-synthetic (man-made) substance based on the scaffold of the natural product oleanolic acid. Bardoxolone methyl was shown to inhibit inflammation-mediated processes and to improve parameters of kidney function in multiple clinical studies.
In this study, bardoxolone methyl will be given to participants as a capsule (pill).
The study has two main purposes:
- To see if bardoxolone methyl pills are safe and well tolerated in patients with ADPKD
- To see if bardoxolone methyl pills improve the estimated glomerular filtration rate (eGFR), a measure of kidney function
The study plans to enroll approximately 300 patients with ADPKD who are between the age of 18 and 70 years at up to 100 global study centers.Summary of Results
The lay language summary is located here: https://www.biogentriallink.com/en-us/home/find-a-clinical-trial/clinical-trials-study-details.html?nctId=NCT03918447
REC name
HSC REC A
REC reference
19/NI/0183
Date of REC Opinion
11 Nov 2019
REC opinion
Further Information Favourable Opinion