Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 22179 for:    Placebo AND subjects

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03888066
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Vifor Pharma
Information provided by (Responsible Party):
Relypsa, Inc.

Brief Summary:
The purpose of this study is to determine if patiromer treatment of subjects who developed hyperkalemia while receiving RAASi medications will result in continued use of RAASi medications in accordance with heart failure (HF) treatment guidelines and thereby decrease the occurrence of the combined endpoint of cardiovascular (CV) death and CV hospitalization events compared with placebo treatment.

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

Detailed Description:

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

Subjects with heart failure 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 in the 12 months 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 (anticipated to be at least 6 months per subject). The study will continue until the required number of composite endpoint events have occurred. Study duration for individual subjects will vary, depending on the rate of occurrence of composite endpoint events. Given the assumptions underlying the study design, accumulation of the requisite number of composite endpoint events is expected to occur over approximately 2.5 years. Subjects who prematurely discontinue patiromer/placebo will remain in the study for the collection of composite endpoint event data and will receive usual care.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2388 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 (all subjects will have RAASi medications, including mineralocorticoid receptor antagonist (MRA), optimized) 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
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

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

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).




Primary Outcome Measures :
  1. Time to first occurrence of CV death or CV hospitalization (or equivalent in outpatient clinic) [ Time Frame: 6 months to 2.5 years ]
    To determine if patiromer treatment of subjects who developed hyperkalemia while receiving RAASi medications will result in continued use of RAASi medications in accordance with heart failure (HF) treatment guidelines and thereby decrease the occurrence of the combined endpoint of cardiovascular (CV) death and CV hospitalization events compared with placebo treatment.


Secondary Outcome Measures :
  1. Proportion of subjects on ≥ 50% of guideline-recommended target dose of RAASi medications [ Time Frame: Through End of Study Visit, approximately 2.5 years ]
    Proportion of subjects on ≥ 50% of guideline-recommended target dose of angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), or ARNi and ≥ 50% of guideline-recommended target dose of MRA at the End of Study Visit

  2. Total HF hospitalizations [ Time Frame: Through End of Study Visit, approximately 2.5 years ]
    Total HF hospitalizations (or equivalent in outpatient clinic)

  3. Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Through End of Study Visit, approximately 2.5 years ]
    Patient reported outcome: Kansas City Cardiomyopathy Questionnaire (KCCQ)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
  • History of 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 the past 12 months which caused reduction or discontinuation of heart failure medications
  • Hospitalization for heart failure or treatment in an out patient setting with intravenous medications within last 12 months

Exclusion Criteria:

  • Current acute decompensated HF. Subjects with a discharge from a hospitalization for acute decompensation of HF at least 4 weeks before Screening may be included
  • Significant primary aortic or mitral valvular heart disease (except mitral regurgitation due to left ventricular dilatation)
  • Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant list) during the study period

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


Contacts
Layout table for location contacts
Contact: Head of Clinical Operations 650-421-9500 Diamond_Study@viforpharma.com

Locations
Layout table for location information
United States, Florida
Investigator Site 11-003 Recruiting
Doral, Florida, United States, 33166
Investigator Site 11-014 Recruiting
Hialeah, Florida, United States, 33016
Research Site 11-001 Recruiting
Miami Lakes, Florida, United States, 33014
Research Site 11-002 Recruiting
Miami Lakes, Florida, United States, 33014
Investigator Site 11-005 Recruiting
Miami, Florida, United States, 33155
Sponsors and Collaborators
Relypsa, Inc.
Vifor Pharma
Investigators
Layout table for investigator information
Study Director: Martha Mayo, PharmD Relypsa, Inc.

Layout table for additonal information
Responsible Party: Relypsa, Inc.
ClinicalTrials.gov Identifier: NCT03888066     History of Changes
Other Study ID Numbers: Relypsa
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: May 2019
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Relypsa, 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:
Layout table for MeSH terms
Heart Failure
Hyperkalemia
Heart Diseases
Cardiovascular Diseases
Water-Electrolyte Imbalance
Metabolic Diseases