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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,195

Participants

Timeline

Start Date

April 24, 2019

Primary Completion Date

September 2, 2021

Study Completion Date

September 2, 2021

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).

Trial Locations (415)

1096

Investigator Site 64-010, Budapest

1097

Investigator Site 64-002, Budapest

1122

Investigator Site 64-006, Budapest

1134

Investigator Site 64-009, Budapest

1200

Investigator Site 44-009, Brussels

1233

Investigator Site 61-009, Sofia

1379

Investigator Site 61-008, Sofia

1425

Investigator Site 21-012, Buenos Aires

1431

Investigator Site 61-005, Sofia

1527

Investigator Site 61-006, Sofia

2143

Investigator Site 64-007, Kistarcsa

2800

Investigator Site 44-002, Mechelen

3000

Investigator Site 21-009, Santa Fe

Investigator Site 44-007, Leuven

Investigator Site 36-003, Rotterdam

3500

Investigator Site 44-008, Hasselt

3600

Investigator Site 44-003, Genk

4000

Investigator Site 21-010, San Miguel de Tucumán

Investigator Site 44-006, Liège

4002

Investigator Site 61-004, Plovdiv

4400

Investigator Site 64-005, Nyíregyháza

4610

Investigator Site 37-008, Valencia

5000

Investigator Site 21-011, Córdoba

5530

Investigator Site 44-004, Yvoir

5700

Investigator Site 21-005, San Luis

5800

Investigator Site 61-002, Pleven

5900

Investigator Site 21-015, Villa María

6000

Investigator Site 64-001, Kecskemét

6004

Investigator Site 63-012, Batumi

6800

Investigator Site 23-011, Oaxaca City

7002

Investigator Site 61-010, Rousse

8000

Investigator Site 61-003, Burgas

8800

Investigator Site 44-010, Roeselare

9000

Investigator Site 44-001, Ghent

10002

Investigator Site 68-004, Zhytomyr

10310

Investigator Site 11-081, Staten Island

10461

Investigator Site 11-127, The Bronx

10789

Investigator Site 33-020, Berlin

11000

Investigator Site 67-010, Belgrade

11030

Investigator Site 11-040, Manhasset

11040

Investigator Site 67-002, Belgrade

11050

Investigator Site 67-004, Belgrade

11080

Investigator Site 67-008, Belgrade

11234

Investigator Site 11-126, Brooklyn

11419

Investigator Site 11-053, Richmond Hill

11794

Investigator Site 11-021, Stony Brook

12004

Investigator Site 37-010, Castellon

12559

Investigator Site 33-013, Berlin

12808

Investigator Site 62-001, Prague

13100

Investigator Site 35-012, Safed

14059

Investigator Site 62-012, Prague

15000

Investigator Site 67-003, Šabac

16132

Investigator Site 34-010, Genova

16507

Investigator Site 11-165, Erie

16902

Investigator Site 62-009, Prague

17033

Investigator Site 11-082, Hershey

17475

Investigator Site 33-008, Greifswald

18000

Investigator Site 67-005, Niš

18205

Investigator Site 67-007, Niška Banja

20138

Investigator Site 34-004, Milan

20246

Investigator Site 33-005, Hamburg

21000

Investigator Site 68-014, Vinnytsia

21044

Investigator Site 11-023, Columbia

21204

Investigator Site 67-001, Kamenitz

21229

Investigator Site 11-027, Baltimore

22000

Investigator Site 32-018, Saint-Brieuc

23507

Investigator Site 11-158, Norfolk

23510

Investigator Site 11-188, Norfolk

24105

Investigator Site 33-017, Kiel

24127

Investigator Site 34-002, Bergamo

25123

Investigator Site 34-007, Brescia

25198

Investigator Site 37-023, Lleida

26506

Investigator Site 11-065, Morgantown

27401

Investigator Site 62-011, Slaný

27834

Investigator Site 11-018, Greenville

28006

Investigator Site 37-021, Madrid

28034

Investigator Site 37-020, Madrid

28040

Investigator Site 37-026, Madrid

28204

Investigator Site 11-120, Charlotte

28207

Investigator Site 11-075, Charlotte

28222

Investigator Site 37-011, Majadahonda

28277

Investigator Site 33-016, Bremen

28358

Investigator Site 11-157, Lumberton

29010

Investigator Site 37-017, Málaga

29121

Investigator Site 34-012, Piacenza

29607

Investigator Site 11-110, Greenville

29646

Investigator Site 11-098, Greenwood

29720

Investigator Site 11-119, Lancaster

29732

Investigator Site 11-133, Rock Hill

30303

Investigator Site 11-109, Atlanta

30625

Investigator Site 33-022, Hanover

31201

Investigator Site 11-141, Macon

31400

Investigator Site 32-012, Toulouse

31904

Investigator Site 11-015, Columbus

32277

Investigator Site 11-179, Jacksonville

32429

Investigator Site 33-024, Minden

32545

Investigator Site 33-023, Bad Oeynhausen

32608

Investigator Site 11-138, Gainesville

32701

Investigator Site 11-168, Altamonte Springs

32807

Investigator Site 11-171, Orlando

32810

Investigator Site 11-025, Orlando

32819

Investigator Site 11-087, Orlando

33014

Research Site 11-001, Miami Lakes

Research Site 11-002, Miami Lakes

33026

Investigator Site 11-177, Pembroke Pines

33033

Investigator Site 11-078, Homestead

33064

Investigator Site 11-144, Pompano Beach

33075

Investigator Site 32-010, Bordeaux

33125

Investigator Site 11-115, Miami

33144

Investigator Site 11-125, Miami

33155

Investigator Site 11-005, Miami

33166

Investigator Site 11-003, Doral

Investigator Site 11-122, Medley

33169

Investigator Site 11-032, North Miami Beach

33321

Investigator Site 11-099, Tamarac

33437

Investigator Site 11-106, Boynton Beach

33467

Investigator Site 11-164, Greenacres City

33511

Investigator Site 11-028, Brandon

33604

Investigator Site 33-015, Bielefeld

33606

Investigator Site 11-090, Tampa

33614

Investigator Site 11-163, Tampa

34295

Investigator Site 32-005, Montpellier

35010

Investigator Site 11-080, Alexander City

35301

Investigator Site 62-010, Mariánské Lázně

35392

Investigator Site 33-018, Giessen

35801

Investigator Site 11-041, Huntsville

37047

Investigator Site 34-013, San Bonifacio

37388

Investigator Site 11-134, Tullahoma

37403

Investigator Site 11-152, Chattanooga

38117

Investigator Site 11-142, Memphis

38138

Investigator Site 11-083, Memphis

38301

Investigator Site 11-091, Jackson

38700

Investigator Site 32-002, La Tronche

39216

Investigator Site 11-068, Jackson

41801

Investigator Site 62-004, Bílina

42303

Investigator Site 11-061, Owensboro

43214

Investigator Site 11-149, Columbus

43623

Investigator Site 11-187, Toledo

44053

Investigator Site 11-064, Lorain

44100

Investigator Site 23-012, Guadalajara

44120

Investigator Site 34-009, Cona

44657

Investigator Site 23-004, Guadalajara

45138

Investigator Site 33-001, Essen

46001

Investigator Site 62-013, Liberec

46321

Investigator Site 11-129, Munster

46410

Investigator Site 11-117, Merrillville

46940

Investigator Site 37-001, Manises

47347

Investigator Site 11-069, Richmond

48154

Investigator Site 11-121, Livonia

48201

Investigator Site 11-123, Detroit

48307

Investigator Site 11-076, Rochester

Investigator Site 11-189, Rochester

49027

Investigator Site 68-017, Dnipro

51092

Investigator Site 32-013, Reims

51375

Investigator Site 33-010, Leverkusen

53226

Investigator Site 11-045, Milwaukee

54500

Investigator Site 32-001, Nancy

54701

Investigator Site 62-018, Náchod

58022

Investigator Site 62-005, Havlíčkův Brod

59000

Investigator Site 32-014, Lille

59200

Investigator Site 32-009, Tourcoing

59300

Investigator Site 32-011, Valenciennes

Investigator Site 32-016, Valenciennes

60005

Investigator Site 11-031, Arlington Heights

60429

Investigator Site 11-051, Hazel Crest

60590

Investigator Site 33-019, Frankfurt

61039

Investigator Site 68-001, Kharkiv

61058

Investigator Site 68-011, Kharkiv

61103

Investigator Site 68-010, Kharkiv

61157

Investigator Site 68-008, Kharkiv

61176

Investigator Site 68-002, Kharkiv

61602

Investigator Site 11-063, Peoria

61614

Investigator Site 11-137, Peoria

63008

Investigator Site 66-002, Novosibirsk

63110

Investigator Site 11-094, St Louis

64000

Investigator Site 32-003, Pau

64111

Investigator Site 11-154, Kansas City

65691

Investigator Site 62-019, Brno

65929

Investigator Site 33-007, Frankfurt

66278

Investigator Site 23-010, San Pedro Garza García

68601

Investigator Site 62-016, Uherské Hradiště

69106

Investigator Site 68-016, Zaporizhzhya

70570

Investigator Site 11-183, Opelousas

71100

Investigator Site 34-014, Foggia

71291

Investigator Site 11-022, West Monroe

73112

Investigator Site 11-124, Oklahoma City

73601

Investigator Site 62-017, Havířov

74006

Investigator Site 11-074, Bartlesville

74177

Investigator Site 33-012, Heilbronn

75010

Investigator Site 32-004, Paris

75013

Investigator Site 11-104, Allen

Investigator Site 11-185, Allen

Investigator Site 32-008, Paris

Investigator Site 32-017, Paris

75018

Investigator Site 32-007, Paris

75020

Investigator Site 11-170, Denison

75071

Investigator Site 11-046, McKinney

75231

Investigator Site 11-176, Dallas

75246

Investigator Site 11-092, Dallas

76000

Investigator Site 32-020, Lyon

Investigator Site 23-001, Querétaro City

76008

Investigator Site 68-009, Ivano-Frankivsk

76018

Investigator Site 68-005, Ivano-Frankivsk

76031

Investigator Site 32-019, Rouen

76104

Investigator Site 11-060, Fort Worth

76550

Investigator Site 11-029, Lampasas

77002

Investigator Site 11-140, Houston

77070

Investigator Site 11-089, Houston

77077

Investigator Site 11-146, Houston

77094

Investigator Site 11-156, Houston

77450

Investigator Site 11-034, Katy

77479

Investigator Site 11-161, Sugar Land

77598

Investigator Site 11-160, Webster

78215

Investigator Site 11-147, San Antonio

78229

Investigator Site 11-085, San Antonio

78278

Investigator Site 35-008, Ashkelon

78401

Investigator Site 62-015, Litovel

78629

Investigator Site 11-072, Gonzales

79013

Investigator Site 68-006, Lviv

79106

Investigator Site 11-070, Amarillo

80045

Investigator Site 11-095, Aurora

80230

Investigator Site 23-002, Culiacán

81100

Investigator Site 34-001, Caserta

83100

Investigator Site 32-006, Toulon

84132

Investigator Site 11-178, Salt Lake City

85108

Investigator Site 11-153, Phoenix

85724

Investigator Site 11-097, Tucson

86021

Investigator Site 32-015, Poitiers

87109

Investigator Site 11-116, Albuquerque

89086

Investigator Site 11-145, North Las Vegas

89102

Investigator Site 11-049, Las Vegas

90402

Investigator Site 33-014, Nuremberg

90813

Investigator Site 11-017, Long Beach

91105

Investigator Site 11-035, Pasadena

91120

Investigator Site 35-014, Jerusalem

91193

Investigator Site 23-006, Xalapa

91240

Investigator Site 35-001, Jerusalem

91307

Investigator Site 11-058, West Hills

91324

Investigator Site 11-128, Northridge

91360

Investigator Site 11-047, Thousand Oaks

91401

Investigator Site 11-057, Van Nuys

91942

Investigator Site 11-048, La Mesa

92037

Investigator Site 11-162, La Jolla

92119

Investigator Site 11-135, San Diego

92161

Investigator Site 11-086, San Diego

92648

Investigator Site 11-102, Huntington Beach

92653

Investigator Site 11-111, Laguna Hills

92705

Investigator Site 11-112, Santa Ana

93308

Investigator Site 11-052, Bakersfield

93720

Investigator Site 11-136, Fresno

94538

Investigator Site 11-174, Fremont

95204

Investigator Site 11-101, Stockton

95816

Investigator Site 11-044, Sacramento

96450

Investigator Site 33-011, Coburg

97078

Investigator Site 33-003, Würzburg

97123

Investigator Site 11-056, Hillsboro

97239

Investigator Site 11-169, Portland

98100

Investigator Site 35-002, Holon

99097

Investigator Site 33-004, Erfurt

111539

Investigator Site 66-015, Moscow

119192

Investigator Site 66-004, Moscow

Investigator Site 66-011, Moscow

124489

Investigator Site 66-017, Moscow

170036

Investigator Site 66-009, Tver'

185019

Investigator Site 66-012, Petrozavodsk

198205

Investigator Site 66-013, Saint Petersburg

199106

Investigator Site 66-003, Saint Petersburg

300008

Investigator Site 37-022, Murcia

390039

Investigator Site 66-018, Ryazan

420033

Investigator Site 66-016, Kazan'

426063

Investigator Site 66-014, Izhevsk

440026

Investigator Site 66-005, Penza

454136

Investigator Site 66-008, Chelyabinsk

614097

Investigator Site 66-007, Perm

620109

Investigator Site 66-001, Yekaterinburg

650002

Investigator Site 66-010, Kemerovo

1520800

Investigator Site 35-016, Tiberias

2210001

Investigator Site 35-010, Nahariya

3109601

Investigator Site 35-006, Haifa

Investigator Site 35-007, Haifa

3810101

Investigator Site 35-003, Hadera

4941492

Investigator Site 35-011, Petah Tikva

5265601

Investigator Site 35-013, Ramat Gan

6093000

Investigator Site 35-009, Be’er Ya‘aqov

9103102

Investigator Site 35-005, Jerusalem

32224-1865

Investigator Site 11-004, Jacksonville

02215

Investigator Site 11-132, Boston

68256-9797

Investigator Site 11-071, Lincoln

08035

Investigator Site 11-088, Haddon Heights

07036

Investigator Site 11-054, Linden

08901

Investigator Site 11-148, New Brunswick

07102

Investigator Site 11-107, Newark

11203-2012

Investigator Site 11-151, Brooklyn

14215-1145

Investigator Site 11-073, Buffalo

43302-6416

Investigator Site 11-042, Marion

C1093AAS

Investigator Site 21-006, Ciudad Autonoma de Buenos Aire

B1702BML

Investigator Site 21-007, Ciudadela

B7602CBM

Investigator Site 21-019, Mar del Plata

B1704ETD

Investigator Site 21-020, Ramos Mejía

B2900DPA

Investigator Site 21-004, San Nicolás de los Arroyos

X5000EVQ

Investigator Site 21-021, Córdoba

X5002AOQ

Investigator Site 21-014, Córdoba

C1023AAB

Investigator Site 21-003, Buenos Aires

C1407GTN

Investigator Site 21-018, Buenos Aires

C1430CKE

Investigator Site 21-008, Buenos Aires

A4406BPF

Investigator Site 21-017, Salta

B-9300

Investigator Site 44-005, Aalst

60430-370

Investigator Site 22-019, Fortaleza

60840-285

Investigator Site 22-013, Fortaleza

29043-260

Investigator Site 22-012, Vitória

40170-130

Investigator Site 22-021, Salvador

70710-100

Investigator Site 22-023, Brasília

30110-934

Investigator Site 22-011, Belo Horizonte

30150-240

Investigator Site 22-005, Belo Horizonte

38411-186

Investigator Site 22-004, Uberlândia

83430-000

Investigator Site 22-010, Campina Grande do Sul

92425-900

Investigator Site 22-008, Canoas

90020-090

Investigator Site 22-003, Porto Alegre

90035-903

Investigator Site 22-015, Porto Alegre

90620-001

Investigator Site 22-002, Porto Alegre

90840-440

Investigator Site 22-009, Porto Alegre

91350-200

Investigator Site 22-025, Porto Alegre

89020-430

Investigator Site 22-017, Blumenau

49055-530

Investigator Site 22-007, Aracaju

13083-970

Investigator Site 22-016, Campinas

14051-140

Investigator Site 22-018, Ribeirão Preto

15015-210

Investigator Site 22-020, São José do Rio Preto

20241-180

Investigator Site 22-024, Rio de Janeiro

05403-000

Investigator Site 22-014, São Paulo

09080-110

Investigator Site 22-022, São Paulo

R2H 2A6

Investigator Site 12-005, Winnipeg

A1B3V6

Investigator Site 12-013, St. John's

N1R7R1

Investigator Site 12-008, Cambridge

N6A 5A5

Investigator Site 12-012, London

L3Y 2P6

Investigator Site 12-010, Newmarket

M5B 1W8

Investigator Site 12-002, Toronto

J4V 2G8

Investigator Site 12-009, Greenfield Park

J1G 2E8

Investigator Site 12-006, Sherbrooke

G8Z 3R9

Investigator Site 12-004, Trois-Rivières

0102

Investigator Site 63-007, Tbilisi

0112

Investigator Site 63-011, Tbilisi

0131

Investigator Site 63-004, Tbilisi

0159

Investigator Site 63-002, Tbilisi

Investigator Site 63-006, Tbilisi

Investigator Site 63-008, Tbilisi

Investigator Site 63-010, Tbilisi

0167

Investigator Site 63-003, Tbilisi

0172

Investigator Site 63-009, Tbilisi

0180

Investigator Site 63-001, Tbilisi

0186

Investigator Site 63-005, Tbilisi

D-66421

Investigator Site 33-006, Homburg

06120

Investigator Site 33-002, Halle

04103

Investigator Site 33-021, Leipzig

Unknown

Investigator Site 34-005, Ancona

Investigator Site 37-025, A Coruña

00163

Investigator Site 34-003, Roma

06090

Investigator Site 23-007, Cuauhtémoc

07020

Investigator Site 23-005, Gustavo Adolfo Madero

5223GZ

Investigator Site 36-002, 's-Hertogenbosch

1186AM

Investigator Site 36-012, Amstelveen

1261 AN

Investigator Site 36-006, Blaricum

3247BW

Investigator Site 36-009, Dirksland

3318 AT

Investigator Site 36-015, Dordrecht

6716 RP

Investigator Site 36-007, Ede

9713 GZ

Investigator Site 36-001, Groningen

5707HA

Investigator Site 36-013, Helmond

1624 NP

Investigator Site 36-014, Hoorn

3118 JH

Investigator Site 36-010, Schiedam

5042 AD

Investigator Site 36-004, Tilburg

3582 KE

Investigator Site 36-011, Utrecht

15-276

Investigator Site 65-007, Bialystok

40-156

Investigator Site 65-014, Katowice

47-200

Investigator Site 65-012, Kędzierzyn-Koźle

90-549

Investigator Site 65-001, Lodz

93-513

Investigator Site 65-018, Lodz

10-010

Investigator Site 65-019, Olsztyn

27-400

Investigator Site 65-015, Ostrowiec Świętokrzyski

81-717

Investigator Site 65-021, Pomorskie

61-485

Investigator Site 65-003, Poznan

61-848

Investigator Site 65-020, Poznan

35-055

Investigator Site 65-008, Rzeszów

50-556

Investigator Site 65-010, Wroclaw

51-162

Investigator Site 65-005, Wroclaw

95-100

Investigator Site 65-011, Zgierz

07120

Investigator Site 37-014, Palma de Mallorca

08003

Investigator Site 37-003, Barcelona

015706

Investigator Site 37-005, Santiago de Compostela

029603

Investigator Site 37-024, Marbella

038320

Investigator Site 37-016, San Cristóbal de La Laguna

03010

Investigator Site 37-012, Alicante

08916

Investigator Site 37-015, Badalona

08041

Investigator Site 37-007, Barcelona

08907

Investigator Site 37-002, Barcelona

021005

Investigator Site 37-018, Huelva

028007

Investigator Site 37-004, Madrid

028041

Investigator Site 37-006, Madrid

041007

Investigator Site 37-013, Seville

046020

Investigator Site 37-009, Valencia

01601

Investigator Site 68-012, Kyiv

0200

Investigator Site 68-003, Kyiv

02166

Investigator Site 68-015, Kyiv

03110

Investigator Site 68-013, Kyiv

04050

Investigator Site 68-007, Kyiv

CM2 01QX

Investigator Site 39-012, Harlow

DN15 7BH

Investigator Site 39-003, Scunthorpe

DY1 2HQ

Investigator Site 39-005, Dudley

S75 2EP

Investigator Site 39-009, Barnsley

HP11 2TT

Investigator Site 39-016, High Wycombe

IV2 3JH

Investigator Site 39-008, Inverness

LE3 9QP

Investigator Site 39-011, Leicester

L9 7AL

Investigator Site 39-013, Liverpool

SE5 9RS

Investigator Site 39-015, London

NE29 8NH

Investigator Site 39-010, North Shields

SA6 6NL

Investigator Site 39-007, Swansea

YO31 8HE

Investigator Site 39-004, York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Vifor Pharma, Inc.

INDUSTRY