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

NCT03071263 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2021-05-12

Study results available
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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).

Conditions

  • Hyperkalemia
  • Resistant Hypertension

Interventions

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

Sponsors & Collaborators

  • Relypsa, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director or VP Clinical Development · Relypsa, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-23
Primary Completion
2018-11-27
Completion
2018-11-27
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Croatia
  • Georgia
  • Germany
  • Hungary
  • South Africa
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03071263 on ClinicalTrials.gov