NCT03071263

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 295 (actual)
• Sponsor: Relypsa, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Hyperkalemia
• Resistant Hypertension

Interventions

Type	Name	Description
DRUG	Patiromer	2 packets/day starting dose, administered orally
DRUG	Placebo	2 packets/day starting dose, administered orally
DRUG	Spironolactone	25 mg tablet/day starting dose, administered orally

Timeline

• Start date: 2017-01-23
• Primary completion: 2018-11-27
• Completion: 2018-11-27
• First posted: 2017-03-06
• Last updated: 2021-05-12
• Results posted: 2020-01-27

Locations

40 sites across 9 countries: United States, Bulgaria, Croatia, Georgia, Germany, Hungary, South Africa, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study