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

Sponsor
Vifor Pharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03888066
Collaborator
Syneos Health, LLC (Other)
878
Enrollment
415
Locations
2
Arms
28.3
Actual Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
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.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 :
Apr 25, 2019
Actual Primary Completion Date :
Sep 2, 2021
Actual Study Completion Date :
Sep 2, 2021

Arms and Interventions

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 Names:
  • 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

    Primary Outcome Measures

    1. Mean change from baseline in serum K+ levels. [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. [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) [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. [From screening, through study completion and up to 2 weeks after the end of study]

    4. Hyperkalemia-related hard outcomes endpoints [Day 1/baseline, through study completion (end of study visit)]

      Analyzed using Win Ratio approach with the following hierarchical components: Time to cardiovascular (CV) death Total number of CV hospitalizations Total number of hyperkalemia toxicity events with serum K+>6.5 mEq/L Total number of hyperkalemia events with serum K+ >6.0 - 6.5 mEq/L Total number of hyperkalemia events with serum K+ >5.0 mEq/L

    5. RAASi Use Score [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: All-cause death Occurrence of a CV hospitalization 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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Investigator Site 11-080 Alexander City Alabama United States 35010
    2 Investigator Site 11-041 Huntsville Alabama United States 35801
    3 Investigator Site 11-153 Phoenix Arizona United States 85108
    4 Investigator Site 11-097 Tucson Arizona United States 85724
    5 Investigator Site 11-052 Bakersfield California United States 93308
    6 Investigator Site 11-174 Fremont California United States 94538
    7 Investigator Site 11-136 Fresno California United States 93720
    8 Investigator Site 11-102 Huntington Beach California United States 92648
    9 Investigator Site 11-162 La Jolla California United States 92037
    10 Investigator Site 11-048 La Mesa California United States 91942
    11 Investigator Site 11-111 Laguna Hills California United States 92653
    12 Investigator Site 11-017 Long Beach California United States 90813
    13 Investigator Site 11-128 Northridge California United States 91324
    14 Investigator Site 11-035 Pasadena California United States 91105
    15 Investigator Site 11-044 Sacramento California United States 95816
    16 Investigator Site 11-135 San Diego California United States 92119
    17 Investigator Site 11-086 San Diego California United States 92161
    18 Investigator Site 11-112 Santa Ana California United States 92705
    19 Investigator Site 11-101 Stockton California United States 95204
    20 Investigator Site 11-047 Thousand Oaks California United States 91360
    21 Investigator Site 11-057 Van Nuys California United States 91401
    22 Investigator Site 11-058 West Hills California United States 91307
    23 Investigator Site 11-095 Aurora Colorado United States 80045
    24 Investigator Site 11-168 Altamonte Springs Florida United States 32701
    25 Investigator Site 11-106 Boynton Beach Florida United States 33437
    26 Investigator Site 11-028 Brandon Florida United States 33511
    27 Investigator Site 11-003 Doral Florida United States 33166
    28 Investigator Site 11-138 Gainesville Florida United States 32608
    29 Investigator Site 11-164 Greenacres City Florida United States 33467
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    31 Investigator Site 11-004 Jacksonville Florida United States 32224-1865
    32 Investigator Site 11-179 Jacksonville Florida United States 32277
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    216 Investigator Site 32-014 Lille France 59000
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    354 Investigator Site 67-010 Belgrade Serbia 11000
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    356 Investigator Site 67-004 Belgrade Serbia 11050
    357 Investigator Site 67-008 Belgrade Serbia 11080
    358 Investigator Site 67-007 Niška Banja Serbia 18205
    359 Investigator Site 67-005 Niš Serbia 18000
    360 Investigator Site 67-001 Sremska Kamenica Serbia 21204
    361 Investigator Site 67-003 Šabac Serbia 15000
    362 Investigator Site 37-014 Palma De Mallorca Baleares Spain 07120
    363 Investigator Site 37-010 Castellón De La Plana Castellon Spain 12004
    364 Investigator Site 37-003 Barcelona Cataluña Spain 08003
    365 Investigator Site 37-005 Santiago De Compostela La Coruña Spain 015706
    366 Investigator Site 37-011 Majadahonda Madrid Spain 28222
    367 Investigator Site 37-024 Marbella Malaga Spain 029603
    368 Investigator Site 37-016 La Laguna Tenerife Spain 038320
    369 Investigator Site 37-001 Manises Valencia Spain 46940
    370 Investigator Site 37-012 Alicante Spain 03010
    371 Investigator Site 37-015 Badalona Spain 08916
    372 Investigator Site 37-007 Barcelona Spain 08041
    373 Investigator Site 37-002 Barcelona Spain 08907
    374 Investigator Site 37-018 Huelva Spain 021005
    375 Investigator Site 37-025 La Coruña Spain
    376 Investigator Site 37-023 Lleida Spain 25198
    377 Investigator Site 37-004 Madrid Spain 028007
    378 Investigator Site 37-006 Madrid Spain 028041
    379 Investigator Site 37-021 Madrid Spain 28006
    380 Investigator Site 37-020 Madrid Spain 28034
    381 Investigator Site 37-026 Madrid Spain 28040
    382 Investigator Site 37-022 Murcia Spain 300008
    383 Investigator Site 37-017 Málaga Spain 29010
    384 Investigator Site 37-013 Sevilla Spain 041007
    385 Investigator Site 37-009 Valencia Spain 046020
    386 Investigator Site 37-008 Valencia Spain 4610
    387 Investigator Site 68-008 Kharkiv Novobavarskiy Ukraine 61157
    388 Investigator Site 68-017 Dnipro Ukraine 49027
    389 Investigator Site 68-009 Ivano-Frankivs'k Ukraine 76008
    390 Investigator Site 68-005 Ivano-Frankivs'k Ukraine 76018
    391 Investigator Site 68-001 Kharkiv Ukraine 61039
    392 Investigator Site 68-011 Kharkiv Ukraine 61058
    393 Investigator Site 68-010 Kharkiv Ukraine 61103
    394 Investigator Site 68-002 Kharkiv Ukraine 61176
    395 Investigator Site 68-012 Kyiv Ukraine 01601
    396 Investigator Site 68-003 Kyiv Ukraine 0200
    397 Investigator Site 68-015 Kyiv Ukraine 02166
    398 Investigator Site 68-013 Kyiv Ukraine 03110
    399 Investigator Site 68-007 Kyiv Ukraine 04050
    400 Investigator Site 68-006 Lviv Ukraine 79013
    401 Investigator Site 68-014 Vinnytsia Ukraine 21000
    402 Investigator Site 68-016 Zaporizhzhya Ukraine 69106
    403 Investigator Site 68-004 Zhytomyr Ukraine 10002
    404 Investigator Site 39-012 Harlow Essex United Kingdom CM2 01QX
    405 Investigator Site 39-003 Scunthorpe North Lincolshire United Kingdom DN15 7BH
    406 Investigator Site 39-005 Dudley West Midlands United Kingdom DY1 2HQ
    407 Investigator Site 39-009 Barnsley United Kingdom S75 2EP
    408 Investigator Site 39-016 High Wycombe United Kingdom HP11 2TT
    409 Investigator Site 39-008 Inverness United Kingdom IV2 3JH
    410 Investigator Site 39-011 Leicester United Kingdom LE3 9QP
    411 Investigator Site 39-013 Liverpool United Kingdom L9 7AL
    412 Investigator Site 39-015 London United Kingdom SE5 9RS
    413 Investigator Site 39-010 North Shields United Kingdom NE29 8NH
    414 Investigator Site 39-007 Swansea United Kingdom SA6 6NL
    415 Investigator Site 39-004 York United Kingdom YO31 8HE

    Sponsors and Collaborators

    • Vifor Pharma, Inc.
    • Syneos Health, LLC

    Investigators

    • Study Director: Peter Szecsödy, MD, Vifor Pharma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vifor Pharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT03888066
    Other Study ID Numbers:
    • PAT-CR-302
    • 2018-005030-38
    First Posted:
    Mar 25, 2019
    Last Update Posted:
    Jan 27, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by 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:
    Heart Failure
    Hyperkalemia

    Study Results

    No Results Posted as of Jan 27, 2022