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Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease — AMBER  

Hyperkalemia Clinical Trial

Official 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

Clinical Trial Summary

The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).

Clinical Trial Description

Approximately 290 eligible participants with [chronic kidney disease (CKD) on stable doses of medication] will be randomly assigned to receive a patiromer or placebo starting dose of two packets a day, once a day. All eligible participants will undergo a screening/run-in period (up to 4 weeks) to determine eligibility for study entry. Eligible participants will be randomized and treated for 12 weeks (Treatment Period) and followed for 2 weeks after completing the patiromer or placebo treatment. There are 8 planned clinic visits during the Treatment Period and one planned visit two weeks after the last dose of patiromer or placebo (Follow-up Period). The dose of patiromer or placebo may be increased or decreased (titrated) based on participants' individual potassium response. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03071263
Study type Interventional
Source Vifor Pharma
Contact
Status Completed
Phase Phase 2
Start date January 23, 2017
Completion date November 27, 2018
View Details
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