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Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)

NCT03888066 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1195

Last updated 2023-02-24

Study results available
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Summary

The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.

Conditions

  • Hyperkalemia

Interventions

DRUG

Patiromer

The starting dose of patiromer will be 1 packet/day and may be taken either with food or without food. Based upon the patiromer treatment algorithm patiromer may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, patiromer may be decreased to a minimum of 0 packets/day. Doses of patiromer will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

DRUG

Placebos

The starting dose of placebo will be 1 packet/day and may be taken either with food or without food. Based upon the placebo treatment algorithm placebo may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, placebo may be decreased to a minimum of 0 packets/day. Doses of placebo will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Vifor Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Szecsödy, MD · Vifor Pharma

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2021-09-02
Completion
2021-09-02
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • Serbia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Companies

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 NCT03888066 on ClinicalTrials.gov