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

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ClinicalTrials.gov Identifier: NCT03888066
Recruitment Status : Completed
First Posted : March 25, 2019
Last Update Posted : January 27, 2022
Sponsor:
Collaborator:
Syneos Health, LLC
Information provided by (Responsible Party):
Vifor Pharma ( Vifor Pharma, Inc. )

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

Condition or disease Intervention/treatment Phase
Hyperkalemia Drug: Patiromer Drug: Placebos Phase 3

Detailed Description:

Prospective Phase 3b multinational, multicenter, double-blind, placebo-controlled, randomized withdrawal, parallel group study that includes screening and up to 12 weeks Run-in Phase (all subjects will have patiromer initiated and RAASi medications, including mineralocorticoid receptor antagonist (MRA) optimized) and a randomized withdrawal Blinded Treatment Phase.

The study population includes subjects with heart failure (HF) with reduced ejection fraction (HFrEF) who are hyperkalemic (serum potassium [K+] > 5.0 mEq/L) while receiving treatment with renin angiotensin aldosterone system inhibitor (RAASi) medications or who are normokalemic (serum K+ 4.0 - 5.0 mEq/L) but have a history of hyperkalemia prior to screening with subsequent reduction or discontinuation of a RAASi medication.

Each subject's participation includes a Run-in Phase (maximum 12 weeks) followed by the Treatment Phase (variable per subject). Study duration for individual subjects will vary, depending on their individual enrollment date. Subjects who prematurely discontinue patiromer/placebo will remain in the study for the collection of clinical events data and will receive usual care.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 878 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Phase 3b multinational, multicenter, double-blind, placebo-controlled, randomized withdrawal, parallel group study that includes screening and 12 weeks Run-in Phase and a randomized withdrawal Blinded Treatment Phase.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)
Actual Study Start Date : April 25, 2019
Actual Primary Completion Date : September 2, 2021
Actual Study Completion Date : September 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Patiromer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: Patiromer
Subjects will be randomized to receive a daily dose of patiromer with possible dose adjustments based on subsequent local serum potassium levels.
 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).
Other Name: Veltassa
Placebo Comparator: Group 2: Placebo
Subjects will be randomized to receive a daily dose of placebo with possible dose adjustments based on subsequent local serum potassium levels.
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline in serum K+ levels. [ Time Frame: Day 1/baseline, through study completion (end of study visit) ]

Secondary Outcome Measures :
  1. Time to the first event of hyperkalemia with a serum K+ value >5.5 mEq/L. [ Time Frame: Day 1/baseline, through study completion (end of study visit) ]
  2. Durable enablement to stay on the MRA target dose (of 50 mg daily spironolactone or eplerenone, respectively) [ Time Frame: Day 1/baseline, through study completion (end of study visit) ]
    The time to the event of reduction of the MRA dose below target

  3. Investigator reported adverse events (AEs) of hyperkalemia. [ Time Frame: From screening, through study completion and up to 2 weeks after the end of study ]
  4. Hyperkalemia-related hard outcomes endpoints [ Time Frame: Day 1/baseline, through study completion (end of study visit) ]

    Analyzed using Win Ratio approach with the following hierarchical components:

    1. Time to cardiovascular (CV) death
    2. Total number of CV hospitalizations
    3. Total number of hyperkalemia toxicity events with serum K+>6.5 mEq/L
    4. Total number of hyperkalemia events with serum K+ >6.0 - 6.5 mEq/L
    5. Total number of hyperkalemia events with serum K+ >5.0 mEq/L

  5. RAASi Use Score [ Time Frame: Day 1/baseline, through study completion (end of study visit) ]

    Analyzed using the Win Ratio approach for each pair of subjects with the following additive components:

    1. All-cause death
    2. Occurrence of a CV hospitalization
    3. HF medication use and dose for i) an ACEi/ARB/ARNi, ii) an MRA, and iii) a beta-blocker

    Each subject in each comparison can have 0-8 points and all subjects are compared using this score at the respective appropriate follow-up time point.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at least 18 years or greater
  • Symptomatic low ejection fraction heart failure (weak heart muscle)
  • Receiving any dose of a beta blocker for the treatment of HF (unless not able to tolerate)
  • Kidney function not more than mild or moderately impaired
  • High blood potassium (>5.0 mEq/L) currently while receiving medications for heart failure OR normal blood potassium currently but previously had high potassium in the12 months prior to screening which caused a permanent reduction or discontinuation of heart failure medications
  • Hospitalization for heart failure or treatment in an out patient setting with intravenous medications within the last 12 months before screening.

Exclusion Criteria:

  • Current acute decompensated HF, within 4 weeks before screening. Subjects with a discharge from a hospitalization for acute decompensation of HF longer than 4 weeks before screening may be included
  • Significant primary aortic or mitral valvular heart disease (except secondary mitral regurgitation due to left ventricular dilatation)
  • Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant waiting list) during the study period
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888066


Locations
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Sponsors and Collaborators
Vifor Pharma, Inc.
Syneos Health, LLC
Investigators
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Study Director: Peter Szecsödy, MD Vifor Pharma
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vifor Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03888066    
Other Study ID Numbers: PAT-CR-302
2018-005030-38 ( EudraCT Number )
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame:

Data can be requested 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later.

Data will be indefinitely available for requesting
Access Criteria: A research proposal must be approved by an independent review panel and the study sponsor and researchers must sign a data sharing agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vifor Pharma ( Vifor Pharma, Inc. ):
treatment of hyperkalemia
chronic kidney disease
hypertension
hyperkalemia
potassium
spironolactone
 heart failure
Renin Angiotensin-Aldosterone System Inhibitor (RAASi)
RAASi
high potassium
eplerenone
reduced ejection fraction
Additional relevant MeSH terms:
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Heart Failure
Hyperkalemia
Heart Diseases
 Cardiovascular Diseases
Water-Electrolyte Imbalance
Metabolic Diseases