Spironolactone with Patiromer in the Treatment of Resistant HTN in CKD
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood Pressure Control in Patients with Resistant Hypertension and Chronic Kidney Disease: Evaluation of Safety and Efficacy (AMBER)
IRAS ID
222279
Contact name
Elaine Lee
Contact email
Sponsor organisation
Relypsa Inc.
Eudract number
2016-002657-38
Duration of Study in the UK
0 years, 10 months, 5 days
Research summary
The study aims to evaluate patiromer treatment with spironolactone in subjects with resistant hypertension and CKD. The study will evaluate whether using patiromer with spironolactone will allow more persistent use of spironolactone by preventing high blood potassium. It is anticipated that more persistent use of spironolactone will result in better blood pressure control. Spironolactone is a medication that has been effective in addition to other medications for the treatment of resistant hypertension (high BP that is difficult to treat with 3 medicatons) but it not used in patients with CKD because of the risk of causing high blood potassium (hyperkalemia).
The study will consist of a Screening/Run-in Period (up to 4 weeks), a 12-week Double-Blind Treatment Phase and a Follow-up Visit 2 weeks after Week 12 or ET Visit.
All subjects in this study will receive spironolactone. Approximately half of the subjects will be receiving patiromer and the other half will be receiving placebo (a substance that does not contain any medicine). Subjects will not be told when are receiving patiromer or when are receiving placebo. Subjects may be told about treatment assignment (patiromer or placebo) after all study participants have completed the study and all unblinded study findings have been determined by Relypsa, Inc.REC name
East Midlands - Derby Research Ethics Committee
REC reference
17/EM/0055
Date of REC Opinion
24 Apr 2017
REC opinion
Further Information Favourable Opinion