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

Part of paid clinical trials in Hollywood, Florida.

Sponsor
Relypsa, Inc.
Study ID
NCT03071263
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Patiromer — DRUG
    2 packets/day starting dose, administered orally
  • Placebo — DRUG
    2 packets/day starting dose, administered orally
  • Spironolactone — DRUG
    25 mg tablet/day starting dose, administered orally

Study Details

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).

Key Dates

Start date
Jan 23, 2017
Status verified
May 2021
Primary completion
Nov 27, 2018
Completion
Nov 27, 2018

Study Design

Enrollment
295 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1 - Patiromer
    spironolactone + blinded patiromer
  • Experimental: Group 2 - Placebo
    spironolactone + blinded placebo

Primary Outcome Measure

Number of Participants Remaining on Spironolactone at Week 12 [ Time Frame: At week 12 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Investigator Site 1012HollywoodFlorida33021-
Investigator Site 1023Miami LakesFlorida33014-
Investigator Site 1022ChicagoIllinois60611-

Find similar trials in Hollywood, FL

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Investigator· Hollywood, FLInvestigator· Miami Lakes, FLInvestigator· Chicago, IL

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