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

Hyperkalemia Clinical Trial

— DIAMOND  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03888066
• Other study ID #: PAT-CR-302
• Secondary ID: 2018-005030-38
• Status: Completed
• Phase: Phase 3
• Start date: April 24, 2019
• Est. completion date: September 2, 2021

Study information

• Verified date: February 2023
• Source: Vifor Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1195
• Est. completion date: September 2, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Hyperkalemia

Intervention

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).
• 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).

Locations

Country	Name	City	State
Argentina	Investigator Site 21-006	Ciudad Autonoma de Buenos Aire	Buenos Aires
Argentina	Investigator Site 21-003	Ciudad Autonoma de Buenos Aires
Argentina	Investigator Site 21-008	Ciudad Autonoma de Buenos Aires
Argentina	Investigator Site 21-012	Ciudad Autonoma de Buenos Aires
Argentina	Investigator Site 21-018	Ciudad Autonoma de Buenos Aires
Argentina	Investigator Site 21-007	Ciudadela	Buenos Aires
Argentina	Investigator Site 21-011	Córdoba	Cordoba
Argentina	Investigator Site 21-014	Córdoba	Cordoba
Argentina	Investigator Site 21-021	Córdoba	Cordoba
Argentina	Investigator Site 21-019	Mar Del Plata	Provincia De Buenos Aires
Argentina	Investigator Site 21-020	Ramos Mejía	Buenos Aires
Argentina	Investigator Site 21-017	Salta
Argentina	Investigator Site 21-005	San Luis
Argentina	Investigator Site 21-010	San Miguel De Tucumán	Tucuman
Argentina	Investigator Site 21-004	San Nicolás	Buenos Aires
Argentina	Investigator Site 21-009	Santa Fe
Argentina	Investigator Site 21-015	Villa María	Cordoba
Belgium	Investigator Site 44-005	Aalst
Belgium	Investigator Site 44-009	Brussels
Belgium	Investigator Site 44-003	Genk
Belgium	Investigator Site 44-001	Ghent	Oost Vlaanderen
Belgium	Investigator Site 44-008	Hasselt
Belgium	Investigator Site 44-007	Leuven
Belgium	Investigator Site 44-006	Liège
Belgium	Investigator Site 44-002	Mechelen	Antwerp
Belgium	Investigator Site 44-010	Roeselare
Belgium	Investigator Site 44-004	Yvoir
Brazil	Investigator Site 22-007	Aracaju	Sergipe
Brazil	Investigator Site 22-005	Belo Horizonte	Minas Gerais
Brazil	Investigator Site 22-011	Belo Horizonte	Minas Gerais
Brazil	Investigator Site 22-017	Blumenau	SC
Brazil	Investigator Site 22-023	Brasília	Distrito Federal
Brazil	Investigator Site 22-010	Campina Grande Do Sul	Paraná
Brazil	Investigator Site 22-016	Campinas	São Paulo
Brazil	Investigator Site 22-008	Canoas	Rio Grande Do Sul
Brazil	Investigator Site 22-013	Fortaleza	Ceará
Brazil	Investigator Site 22-019	Fortaleza	Ceará
Brazil	Investigator Site 22-002	Porto Alegre	RS
Brazil	Investigator Site 22-003	Porto Alegre	RS
Brazil	Investigator Site 22-009	Porto Alegre	Rio Grande Do Sul
Brazil	Investigator Site 22-015	Porto Alegre	RS
Brazil	Investigator Site 22-025	Porto Alegre	RS
Brazil	Investigator Site 22-018	Ribeirão Preto	São Paulo
Brazil	Investigator Site 22-024	Rio De Janeiro
Brazil	Investigator Site 22-021	Salvador	Bahia
Brazil	Investigator Site 22-020	São José Do Rio Preto	São Paulo
Brazil	Investigator Site 22-014	São Paulo
Brazil	Investigator Site 22-022	São Paulo
Brazil	Investigator Site 22-004	Uberlândia	Minas Gerais
Brazil	Investigator Site 22-012	Vitória	Espirito Santo
Bulgaria	Investigator Site 61-003	Burgas
Bulgaria	Investigator Site 61-002	Pleven
Bulgaria	Investigator Site 61-004	Plovdiv
Bulgaria	Investigator Site 61-010	Ruse
Bulgaria	Investigator Site 61-005	Sofia
Bulgaria	Investigator Site 61-006	Sofia
Bulgaria	Investigator Site 61-008	Sofia
Bulgaria	Investigator Site 61-009	Sofia
Canada	Investigator Site 12-008	Cambridge	Ontario
Canada	Investigator Site 12-009	Greenfield Park	Quebec
Canada	Investigator Site 12-012	London	Ontario
Canada	Investigator Site 12-010	Newmarket	Ontario
Canada	Investigator Site 12-013	Saint John's	Newfoundland and Labrador
Canada	Investigator Site 12-006	Sherbrooke	Quebec
Canada	Investigator Site 12-002	Toronto	Ontario
Canada	Investigator Site 12-004	Trois-Rivières	Quebec
Canada	Investigator Site 12-005	Winnipeg	Manitoba
Czechia	Investigator Site 62-004	Bílina
Czechia	Investigator Site 62-019	Brno
Czechia	Investigator Site 62-017	Havírov
Czechia	Investigator Site 62-005	Havlíckuv Brod
Czechia	Investigator Site 62-013	Liberec
Czechia	Investigator Site 62-015	Litovel
Czechia	Investigator Site 62-010	Mariánské Lázne
Czechia	Investigator Site 62-018	Náchod
Czechia	Investigator Site 62-001	Praha
Czechia	Investigator Site 62-009	Praha
Czechia	Investigator Site 62-012	Praha
Czechia	Investigator Site 62-011	Slaný
Czechia	Investigator Site 62-016	Uherské Hradište
France	Investigator Site 32-010	Bordeaux
France	Investigator Site 32-002	La Tronche
France	Investigator Site 32-014	Lille
France	Investigator Site 32-020	Lyon
France	Investigator Site 32-005	Montpellier
France	Investigator Site 32-001	Nancy
France	Investigator Site 32-004	Paris
France	Investigator Site 32-007	Paris
France	Investigator Site 32-008	Paris
France	Investigator Site 32-017	Paris
France	Investigator Site 32-003	Pau
France	Investigator Site 32-015	Poitiers
France	Investigator Site 32-013	Reims
France	Investigator Site 32-019	Rouen
France	Investigator Site 32-018	Saint-Brieuc
France	Investigator Site 32-006	Toulon
France	Investigator Site 32-012	Toulouse
France	Investigator Site 32-009	Tourcoing
France	Investigator Site 32-011	Valenciennes
France	Investigator Site 32-016	Valenciennes
Georgia	Investigator Site 63-012	Batumi
Georgia	Investigator Site 63-001	Tbilisi
Georgia	Investigator Site 63-002	Tbilisi
Georgia	Investigator Site 63-003	Tbilisi
Georgia	Investigator Site 63-004	Tbilisi
Georgia	Investigator Site 63-005	Tbilisi
Georgia	Investigator Site 63-006	Tbilisi
Georgia	Investigator Site 63-007	Tbilisi
Georgia	Investigator Site 63-008	Tbilisi
Georgia	Investigator Site 63-009	Tbilisi
Georgia	Investigator Site 63-010	Tbilisi
Georgia	Investigator Site 63-011	Tbilisi
Germany	Investigator Site 33-023	Bad Oeynhausen
Germany	Investigator Site 33-013	Berlin
Germany	Investigator Site 33-020	Berlin
Germany	Investigator Site 33-015	Bielefeld
Germany	Investigator Site 33-016	Bremen
Germany	Investigator Site 33-011	Coburg	Bavarian
Germany	Investigator Site 33-004	Erfurt
Germany	Investigator Site 33-001	Essen
Germany	Investigator Site 33-007	Frankfurt
Germany	Investigator Site 33-019	Frankfurt
Germany	Investigator Site 33-018	Gießen
Germany	Investigator Site 33-008	Greifswald	Mecklenburg-Vorpommern
Germany	Investigator Site 33-002	Halle
Germany	Investigator Site 33-005	Hamburg
Germany	Investigator Site 33-022	Hanover
Germany	Investigator Site 33-012	Heilbronn
Germany	Investigator Site 33-006	Homburg	Saar
Germany	Investigator Site 33-017	Kiel
Germany	Investigator Site 33-021	Leipzig
Germany	Investigator Site 33-010	Leverkusen
Germany	Investigator Site 33-024	Minden
Germany	Investigator Site 33-014	Nürnberg
Germany	Investigator Site 33-003	Würzburg
Hungary	Investigator Site 64-002	Budapest
Hungary	Investigator Site 64-006	Budapest
Hungary	Investigator Site 64-009	Budapest
Hungary	Investigator Site 64-010	Budapest
Hungary	Investigator Site 64-001	Kecskemét
Hungary	Investigator Site 64-007	Kistarcsa
Hungary	Investigator Site 64-005	Nyiregyhaza
Israel	Investigator Site 35-008	Ashqelon
Israel	Investigator Site 35-009	Be'er Ya'aqov
Israel	Investigator Site 35-002	H_olon
Israel	Investigator Site 35-003	Hadera
Israel	Investigator Site 35-006	Haifa
Israel	Investigator Site 35-007	Haifa
Israel	Investigator Site 35-001	Jerusalem
Israel	Investigator Site 35-005	Jerusalem
Israel	Investigator Site 35-014	Jerusalem
Israel	Investigator Site 35-010	Nahariya
Israel	Investigator Site 35-011	Petah tikva
Israel	Investigator Site 35-013	Ramat Gan
Israel	Investigator Site 35-012	Safed
Israel	Investigator Site 35-016	Tiberias
Italy	Investigator Site 34-005	Ancona
Italy	Investigator Site 34-002	Bergamo
Italy	Investigator Site 34-007	Brescia
Italy	Investigator Site 34-001	Caserta
Italy	Investigator Site 34-009	Cona
Italy	Investigator Site 34-014	Foggia
Italy	Investigator Site 34-010	Genova
Italy	Investigator Site 34-004	Milano
Italy	Investigator Site 34-012	Piacenza
Italy	Investigator Site 34-003	Roma
Italy	Investigator Site 34-013	San Bonifacio
Mexico	Investigator Site 23-007	Cuauhtémoc	Ciudad De Mexico
Mexico	Investigator Site 23-002	Culiacán	Sinaloa
Mexico	Investigator Site 23-005	Delegación Gustavo A. Madero	Ciudad De Mexico
Mexico	Investigator Site 23-004	Guadalajara	Jalisco
Mexico	Investigator Site 23-012	Guadalajara	Jalisco
Mexico	Investigator Site 23-011	Oaxaca de Juarez	Oaxaca
Mexico	Investigator Site 23-010	San Pedro Garza Garcia	Nuevo Léon
Mexico	Investigator Site 23-001	Santiago De Querétaro	Querétaro
Mexico	Investigator Site 23-006	Xalapa	Veracruz
Netherlands	Investigator Site 36-002	's-Hertogenbosch
Netherlands	Investigator Site 36-012	Amstelveen
Netherlands	Investigator Site 36-006	Blaricum
Netherlands	Investigator Site 36-009	Dirksland
Netherlands	Investigator Site 36-015	Dordrecht
Netherlands	Investigator Site 36-007	Ede
Netherlands	Investigator Site 36-001	Groningen
Netherlands	Investigator Site 36-013	Helmond
Netherlands	Investigator Site 36-014	Hoorn
Netherlands	Investigator Site 36-003	Rotterdam	South Holland
Netherlands	Investigator Site 36-010	Schiedam
Netherlands	Investigator Site 36-004	Tilburg
Netherlands	Investigator Site 36-011	Utrecht
Poland	Investigator Site 65-007	Bialystok
Poland	Investigator Site 65-014	Katowice
Poland	Investigator Site 65-012	Kedzierzyn-Kozle
Poland	Investigator Site 65-001	Lódz
Poland	Investigator Site 65-018	Lódz
Poland	Investigator Site 65-019	Olsztyn
Poland	Investigator Site 65-015	Ostrowiec Swietokrzyski
Poland	Investigator Site 65-021	Pomorskie
Poland	Investigator Site 65-003	Poznan
Poland	Investigator Site 65-020	Poznan
Poland	Investigator Site 65-008	Rzeszów
Poland	Investigator Site 65-005	Wroclaw
Poland	Investigator Site 65-010	Wroclaw
Poland	Investigator Site 65-011	Zgierz
Russian Federation	Investigator Site 66-008	Chelyabinsk
Russian Federation	Investigator Site 66-001	Ekaterinburg
Russian Federation	Investigator Site 66-014	Izhevsk	Udmurt Republic
Russian Federation	Investigator Site 66-016	Kazan
Russian Federation	Investigator Site 66-010	Kemerovo
Russian Federation	Investigator Site 66-004	Moscow
Russian Federation	Investigator Site 66-011	Moscow
Russian Federation	Investigator Site 66-015	Moscow
Russian Federation	Investigator Site 66-017	Moscow
Russian Federation	Investigator Site 66-002	Novosibirsk
Russian Federation	Investigator Site 66-005	Penza
Russian Federation	Investigator Site 66-007	Perm
Russian Federation	Investigator Site 66-012	Petrozavodsk
Russian Federation	Investigator Site 66-018	Ryazan'
Russian Federation	Investigator Site 66-003	Saint Petersburg
Russian Federation	Investigator Site 66-013	Saint Petersburg
Russian Federation	Investigator Site 66-009	Tver
Serbia	Investigator Site 67-003	Šabac
Serbia	Investigator Site 67-002	Belgrade
Serbia	Investigator Site 67-004	Belgrade
Serbia	Investigator Site 67-008	Belgrade
Serbia	Investigator Site 67-010	Belgrade
Serbia	Investigator Site 67-005	Niš
Serbia	Investigator Site 67-007	Niška Banja
Serbia	Investigator Site 67-001	Sremska Kamenica
Spain	Investigator Site 37-012	Alicante
Spain	Investigator Site 37-015	Badalona
Spain	Investigator Site 37-002	Barcelona
Spain	Investigator Site 37-003	Barcelona	Cataluña
Spain	Investigator Site 37-007	Barcelona
Spain	Investigator Site 37-010	Castellón De La Plana	Castellon
Spain	Investigator Site 37-018	Huelva
Spain	Investigator Site 37-025	La Coruña
Spain	Investigator Site 37-016	La Laguna	Tenerife
Spain	Investigator Site 37-023	Lleida
Spain	Investigator Site 37-004	Madrid
Spain	Investigator Site 37-006	Madrid
Spain	Investigator Site 37-020	Madrid
Spain	Investigator Site 37-021	Madrid
Spain	Investigator Site 37-026	Madrid
Spain	Investigator Site 37-011	Majadahonda	Madrid
Spain	Investigator Site 37-017	Málaga
Spain	Investigator Site 37-001	Manises	Valencia
Spain	Investigator Site 37-024	Marbella	Malaga
Spain	Investigator Site 37-022	Murcia
Spain	Investigator Site 37-014	Palma De Mallorca	Baleares
Spain	Investigator Site 37-005	Santiago De Compostela	La Coruña
Spain	Investigator Site 37-013	Sevilla
Spain	Investigator Site 37-008	Valencia
Spain	Investigator Site 37-009	Valencia
Ukraine	Investigator Site 68-017	Dnipro
Ukraine	Investigator Site 68-005	Ivano-Frankivs'k
Ukraine	Investigator Site 68-009	Ivano-Frankivs'k
Ukraine	Investigator Site 68-001	Kharkiv
Ukraine	Investigator Site 68-002	Kharkiv
Ukraine	Investigator Site 68-008	Kharkiv	Novobavarskiy
Ukraine	Investigator Site 68-010	Kharkiv
Ukraine	Investigator Site 68-011	Kharkiv
Ukraine	Investigator Site 68-003	Kyiv
Ukraine	Investigator Site 68-007	Kyiv
Ukraine	Investigator Site 68-012	Kyiv
Ukraine	Investigator Site 68-013	Kyiv
Ukraine	Investigator Site 68-015	Kyiv
Ukraine	Investigator Site 68-006	Lviv
Ukraine	Investigator Site 68-014	Vinnytsia
Ukraine	Investigator Site 68-016	Zaporizhzhya
Ukraine	Investigator Site 68-004	Zhytomyr
United Kingdom	Investigator Site 39-009	Barnsley
United Kingdom	Investigator Site 39-005	Dudley	West Midlands
United Kingdom	Investigator Site 39-012	Harlow	Essex
United Kingdom	Investigator Site 39-016	High Wycombe
United Kingdom	Investigator Site 39-008	Inverness
United Kingdom	Investigator Site 39-011	Leicester
United Kingdom	Investigator Site 39-013	Liverpool
United Kingdom	Investigator Site 39-015	London
United Kingdom	Investigator Site 39-010	North Shields
United Kingdom	Investigator Site 39-003	Scunthorpe	North Lincolshire
United Kingdom	Investigator Site 39-007	Swansea
United Kingdom	Investigator Site 39-004	York
United States	Investigator Site 11-116	Albuquerque	New Mexico
United States	Investigator Site 11-080	Alexander City	Alabama
United States	Investigator Site 11-104	Allen	Texas
United States	Investigator Site 11-185	Allen	Texas
United States	Investigator Site 11-168	Altamonte Springs	Florida
United States	Investigator Site 11-070	Amarillo	Texas
United States	Investigator Site 11-031	Arlington Heights	Illinois
United States	Investigator Site 11-109	Atlanta	Georgia
United States	Investigator Site 11-095	Aurora	Colorado
United States	Investigator Site 11-052	Bakersfield	California
United States	Investigator Site 11-027	Baltimore	Maryland
United States	Investigator Site 11-074	Bartlesville	Oklahoma
United States	Investigator Site 11-132	Boston	Massachusetts
United States	Investigator Site 11-106	Boynton Beach	Florida
United States	Investigator Site 11-028	Brandon	Florida
United States	Investigator Site 11-127	Bronx	New York
United States	Investigator Site 11-126	Brooklyn	New York
United States	Investigator Site 11-151	Brooklyn	New York
United States	Investigator Site 11-073	Buffalo	New York
United States	Investigator Site 11-075	Charlotte	North Carolina
United States	Investigator Site 11-120	Charlotte	North Carolina
United States	Investigator Site 11-152	Chattanooga	Tennessee
United States	Investigator Site 11-023	Columbia	Maryland
United States	Investigator Site 11-015	Columbus	Georgia
United States	Investigator Site 11-149	Columbus	Ohio
United States	Investigator Site 11-092	Dallas	Texas
United States	Investigator Site 11-176	Dallas	Texas
United States	Investigator Site 11-170	Denison	Texas
United States	Investigator Site 11-123	Detroit	Michigan
United States	Investigator Site 11-003	Doral	Florida
United States	Investigator Site 11-165	Erie	Pennsylvania
United States	Investigator Site 11-060	Fort Worth	Texas
United States	Investigator Site 11-174	Fremont	California
United States	Investigator Site 11-136	Fresno	California
United States	Investigator Site 11-138	Gainesville	Florida
United States	Investigator Site 11-072	Gonzales	Texas
United States	Investigator Site 11-164	Greenacres City	Florida
United States	Investigator Site 11-018	Greenville	North Carolina
United States	Investigator Site 11-110	Greenville	South Carolina
United States	Investigator Site 11-098	Greenwood	South Carolina
United States	Investigator Site 11-088	Haddon Heights	New Jersey
United States	Investigator Site 11-051	Hazel Crest	Illinois
United States	Investigator Site 11-082	Hershey	Pennsylvania
United States	Investigator Site 11-056	Hillsboro	Oregon
United States	Investigator Site 11-078	Homestead	Florida
United States	Investigator Site 11-089	Houston	Texas
United States	Investigator Site 11-140	Houston	Texas
United States	Investigator Site 11-146	Houston	Texas
United States	Investigator Site 11-156	Houston	Texas
United States	Investigator Site 11-102	Huntington Beach	California
United States	Investigator Site 11-041	Huntsville	Alabama
United States	Investigator Site 11-068	Jackson	Mississippi
United States	Investigator Site 11-091	Jackson	Tennessee
United States	Investigator Site 11-004	Jacksonville	Florida
United States	Investigator Site 11-179	Jacksonville	Florida
United States	Investigator Site 11-154	Kansas City	Missouri
United States	Investigator Site 11-034	Katy	Texas
United States	Investigator Site 11-162	La Jolla	California
United States	Investigator Site 11-048	La Mesa	California
United States	Investigator Site 11-111	Laguna Hills	California
United States	Investigator Site 11-029	Lampasas	Texas
United States	Investigator Site 11-119	Lancaster	South Carolina
United States	Investigator Site 11-049	Las Vegas	Nevada
United States	Investigator Site 11-071	Lincoln	Nebraska
United States	Investigator Site 11-054	Linden	New Jersey
United States	Investigator Site 11-121	Livonia	Michigan
United States	Investigator Site 11-017	Long Beach	California
United States	Investigator Site 11-064	Lorain	Ohio
United States	Investigator Site 11-157	Lumberton	North Carolina
United States	Investigator Site 11-141	Macon	Georgia
United States	Investigator Site 11-040	Manhasset	New York
United States	Investigator Site 11-042	Marion	Ohio
United States	Investigator Site 11-046	McKinney	Texas
United States	Investigator Site 11-122	Medley	Florida
United States	Investigator Site 11-083	Memphis	Tennessee
United States	Investigator Site 11-142	Memphis	Tennessee
United States	Investigator Site 11-117	Merrillville	Indiana
United States	Investigator Site 11-005	Miami	Florida
United States	Investigator Site 11-115	Miami	Florida
United States	Investigator Site 11-125	Miami	Florida
United States	Research Site 11-001	Miami Lakes	Florida
United States	Research Site 11-002	Miami Lakes	Florida
United States	Investigator Site 11-045	Milwaukee	Wisconsin
United States	Investigator Site 11-065	Morgantown	West Virginia
United States	Investigator Site 11-129	Munster	Indiana
United States	Investigator Site 11-148	New Brunswick	New Jersey
United States	Investigator Site 11-107	Newark	New Jersey
United States	Investigator Site 11-158	Norfolk	Virginia
United States	Investigator Site 11-188	Norfolk	Virginia
United States	Investigator Site 11-145	North Las Vegas	Nevada
United States	Investigator Site 11-032	North Miami Beach	Florida
United States	Investigator Site 11-128	Northridge	California
United States	Investigator Site 11-124	Oklahoma City	Oklahoma
United States	Investigator Site 11-183	Opelousas	Louisiana
United States	Investigator Site 11-025	Orlando	Florida
United States	Investigator Site 11-087	Orlando	Florida
United States	Investigator Site 11-171	Orlando	Florida
United States	Investigator Site 11-061	Owensboro	Kentucky
United States	Investigator Site 11-035	Pasadena	California
United States	Investigator Site 11-177	Pembroke Pines	Florida
United States	Investigator Site 11-063	Peoria	Illinois
United States	Investigator Site 11-137	Peoria	Illinois
United States	Investigator Site 11-153	Phoenix	Arizona
United States	Investigator Site 11-144	Pompano Beach	Florida
United States	Investigator Site 11-169	Portland	Oregon
United States	Investigator Site 11-069	Richmond	Indiana
United States	Investigator Site 11-053	Richmond Hill	New York
United States	Investigator Site 11-076	Rochester	Michigan
United States	Investigator Site 11-189	Rochester	Michigan
United States	Investigator Site 11-133	Rock Hill	South Carolina
United States	Investigator Site 11-044	Sacramento	California
United States	Investigator Site 11-094	Saint Louis	Missouri
United States	Investigator Site 11-178	Salt Lake City	Utah
United States	Investigator Site 11-085	San Antonio	Texas
United States	Investigator Site 11-147	San Antonio	Texas
United States	Investigator Site 11-086	San Diego	California
United States	Investigator Site 11-135	San Diego	California
United States	Investigator Site 11-112	Santa Ana	California
United States	Investigator Site 11-081	Staten Island	New York
United States	Investigator Site 11-101	Stockton	California
United States	Investigator Site 11-021	Stony Brook	New York
United States	Investigator Site 11-161	Sugar Land	Texas
United States	Investigator Site 11-099	Tamarac	Florida
United States	Investigator Site 11-090	Tampa	Florida
United States	Investigator Site 11-163	Tampa	Florida
United States	Investigator Site 11-047	Thousand Oaks	California
United States	Investigator Site 11-187	Toledo	Ohio
United States	Investigator Site 11-097	Tucson	Arizona
United States	Investigator Site 11-134	Tullahoma	Tennessee
United States	Investigator Site 11-057	Van Nuys	California
United States	Investigator Site 11-160	Webster	Texas
United States	Investigator Site 11-058	West Hills	California
United States	Investigator Site 11-022	West Monroe	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Vifor Pharma, Inc.	Syneos Health, LLC

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Serum K+ Levels From Baseline	Adjusted mean changes in serum K+ from Baseline.	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
Secondary	CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time	Cumulative incidence of the first event of hyperkalemia with a serum K+ value >5.5 mEq/l taking death as competing and calculated as CIF Estimates (95% CI) over time.; Aalen-Johansen estimators of the cumulative incidence function with death as a competing event.; CIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter	From Day 1/Baseline to week 90
Secondary	CIF Estimates of the Reduction of the MRA Dose Below Target Dose Over Time	Cumulative incidence of the reduction of the MRA dose below target dose calculated as CIF Estimates (95% CI) over time.; Note: The reduction below the MRA target dose must last for at least 14 days (orless if at the end of study) to confirm this endpoint.; CIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter	From Day 1/Baseline to week 102
Secondary	Investigator-reported Events of Hyperkalemia	Participant's follow-up is from the date of the first dose of randomized study medication up to the participant's end of study date or 24 Jun 2021, whichever comes first.; Annualized event rate per 100 subject-years= The total number of events for all subjects in the treatment group divided by the total subject-years of follow-up in that treatment group multiplied by 100.	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
Secondary	Hyperkalemia-related Hard Outcomes Endpoints	Analyzed using Win Ratio approach with the following hierarchical components: Time to 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; MHTE=More hyperkalemia toxicity events; MHE=More hyperkalemia events; CV=Cardiovascular	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo
Secondary	RAASi Use Score	RAASi use score (0 to 8 points) analyzed using the Win Ratio approach for each pair of participants 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) a MRA, and iii) a beta-blocker; Each participant in each comparison can have 0-8 points and all participants are compared using this score at the respective appropriate follow-up time point.; RAASi=renin-angiotensin-aldosterone system inhibitor; ACEi=angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARNi=angiotensin receptor/neprilysin inhibitor; MRA=mineralocorticoid receptor antagonist.	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo