AzTrials
AzTrials

HyperkalemiaPhase 3DIAMONDNCT03888066

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

A Phase 3 study testing Patiromer in people with Hyperkalemia, run by Vifor Pharma, Inc. at 415 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperkalemia
What is being tested?
Patiromer
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,195 participants
Where
415 sitesin 21 countries
Study dates
24 Apr 2019to 2 Sep 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

415 sites in 21 countries.

415 sites in 21 countries

United States133 sites

  • Investigator Site 11-116

    Albuquerque, New Mexico, 87109

  • Investigator Site 11-080

    Alexander City, Alabama, 35010

  • Investigator Site 11-104

    Allen, Texas, 75013

  • Investigator Site 11-185

    Allen, Texas, 75013

  • Investigator Site 11-168

    Altamonte Springs, Florida, 32701

  • Investigator Site 11-070

    Amarillo, Texas, 79106

  • Investigator Site 11-031

    Arlington Heights, Illinois, 60005

  • Investigator Site 11-109

    Atlanta, Georgia, 30303

  • Investigator Site 11-095

    Aurora, Colorado, 80045

  • Investigator Site 11-052

    Bakersfield, California, 93308

  • Investigator Site 11-027

    Baltimore, Maryland, 21229

  • Investigator Site 11-074

    Bartlesville, Oklahoma, 74006

  • Investigator Site 11-132

    Boston, Massachusetts, 02215

  • Investigator Site 11-106

    Boynton Beach, Florida, 33437

  • Investigator Site 11-028

    Brandon, Florida, 33511

  • Investigator Site 11-151

    Brooklyn, New York, 11203-2012

  • Investigator Site 11-126

    Brooklyn, New York, 11234

  • Investigator Site 11-073

    Buffalo, New York, 14215-1145

  • Investigator Site 11-120

    Charlotte, North Carolina, 28204

  • Investigator Site 11-075

    Charlotte, North Carolina, 28207

  • Investigator Site 11-152

    Chattanooga, Tennessee, 37403

  • Investigator Site 11-023

    Columbia, Maryland, 21044

  • Investigator Site 11-015

    Columbus, Georgia, 31904

  • Investigator Site 11-149

    Columbus, Ohio, 43214

  • Investigator Site 11-176

    Dallas, Texas, 75231

  • Investigator Site 11-092

    Dallas, Texas, 75246

  • Investigator Site 11-170

    Denison, Texas, 75020

  • Investigator Site 11-123

    Detroit, Michigan, 48201

  • Investigator Site 11-003

    Doral, Florida, 33166

  • Investigator Site 11-165

    Erie, Pennsylvania, 16507

  • Investigator Site 11-060

    Fort Worth, Texas, 76104

  • Investigator Site 11-174

    Fremont, California, 94538

  • Investigator Site 11-136

    Fresno, California, 93720

  • Investigator Site 11-138

    Gainesville, Florida, 32608

  • Investigator Site 11-072

    Gonzales, Texas, 78629

  • Investigator Site 11-164

    Greenacres City, Florida, 33467

  • Investigator Site 11-018

    Greenville, North Carolina, 27834

  • Investigator Site 11-110

    Greenville, South Carolina, 29607

  • Investigator Site 11-098

    Greenwood, South Carolina, 29646

  • Investigator Site 11-088

    Haddon Heights, New Jersey, 08035

  • Investigator Site 11-051

    Hazel Crest, Illinois, 60429

  • Investigator Site 11-082

    Hershey, Pennsylvania, 17033

  • Investigator Site 11-056

    Hillsboro, Oregon, 97123

  • Investigator Site 11-078

    Homestead, Florida, 33033

  • Investigator Site 11-140

    Houston, Texas, 77002

  • Investigator Site 11-089

    Houston, Texas, 77070

  • Investigator Site 11-146

    Houston, Texas, 77077

  • Investigator Site 11-156

    Houston, Texas, 77094

  • Investigator Site 11-102

    Huntington Beach, California, 92648

  • Investigator Site 11-041

    Huntsville, Alabama, 35801

  • Investigator Site 11-068

    Jackson, Mississippi, 39216

  • Investigator Site 11-091

    Jackson, Tennessee, 38301

  • Investigator Site 11-004

    Jacksonville, Florida, 32224-1865

  • Investigator Site 11-179

    Jacksonville, Florida, 32277

  • Investigator Site 11-154

    Kansas City, Missouri, 64111

  • Investigator Site 11-034

    Katy, Texas, 77450

  • Investigator Site 11-162

    La Jolla, California, 92037

  • Investigator Site 11-048

    La Mesa, California, 91942

  • Investigator Site 11-111

    Laguna Hills, California, 92653

  • Investigator Site 11-029

    Lampasas, Texas, 76550

  • Investigator Site 11-119

    Lancaster, South Carolina, 29720

  • Investigator Site 11-049

    Las Vegas, Nevada, 89102

  • Investigator Site 11-071

    Lincoln, Nebraska, 68256-9797

  • Investigator Site 11-054

    Linden, New Jersey, 07036

  • Investigator Site 11-121

    Livonia, Michigan, 48154

  • Investigator Site 11-017

    Long Beach, California, 90813

  • Investigator Site 11-064

    Lorain, Ohio, 44053

  • Investigator Site 11-157

    Lumberton, North Carolina, 28358

  • Investigator Site 11-141

    Macon, Georgia, 31201

  • Investigator Site 11-040

    Manhasset, New York, 11030

  • Investigator Site 11-042

    Marion, Ohio, 43302-6416

  • Investigator Site 11-046

    McKinney, Texas, 75071

  • Investigator Site 11-122

    Medley, Florida, 33166

  • Investigator Site 11-142

    Memphis, Tennessee, 38117

  • Investigator Site 11-083

    Memphis, Tennessee, 38138

  • Investigator Site 11-117

    Merrillville, Indiana, 46410

  • Investigator Site 11-115

    Miami, Florida, 33125

  • Investigator Site 11-125

    Miami, Florida, 33144

  • Investigator Site 11-005

    Miami, Florida, 33155

  • Research Site 11-001

    Miami Lakes, Florida, 33014

  • Research Site 11-002

    Miami Lakes, Florida, 33014

  • Investigator Site 11-045

    Milwaukee, Wisconsin, 53226

  • Investigator Site 11-065

    Morgantown, West Virginia, 26506

  • Investigator Site 11-129

    Munster, Indiana, 46321

  • Investigator Site 11-148

    New Brunswick, New Jersey, 08901

  • Investigator Site 11-107

    Newark, New Jersey, 07102

  • Investigator Site 11-158

    Norfolk, Virginia, 23507

  • Investigator Site 11-188

    Norfolk, Virginia, 23510

  • Investigator Site 11-145

    North Las Vegas, Nevada, 89086

  • Investigator Site 11-032

    North Miami Beach, Florida, 33169

  • Investigator Site 11-128

    Northridge, California, 91324

  • Investigator Site 11-124

    Oklahoma City, Oklahoma, 73112

  • Investigator Site 11-183

    Opelousas, Louisiana, 70570

  • Investigator Site 11-171

    Orlando, Florida, 32807

  • Investigator Site 11-025

    Orlando, Florida, 32810

  • Investigator Site 11-087

    Orlando, Florida, 32819

  • Investigator Site 11-061

    Owensboro, Kentucky, 42303

  • Investigator Site 11-035

    Pasadena, California, 91105

  • Investigator Site 11-177

    Pembroke Pines, Florida, 33026

  • Investigator Site 11-063

    Peoria, Illinois, 61602

  • Investigator Site 11-137

    Peoria, Illinois, 61614

  • Investigator Site 11-153

    Phoenix, Arizona, 85108

  • Investigator Site 11-144

    Pompano Beach, Florida, 33064

  • Investigator Site 11-169

    Portland, Oregon, 97239

  • Investigator Site 11-069

    Richmond, Indiana, 47347

  • Investigator Site 11-053

    Richmond Hill, New York, 11419

  • Investigator Site 11-076

    Rochester, Michigan, 48307

  • Investigator Site 11-189

    Rochester, Michigan, 48307

  • Investigator Site 11-133

    Rock Hill, South Carolina, 29732

  • Investigator Site 11-044

    Sacramento, California, 95816

  • Investigator Site 11-178

    Salt Lake City, Utah, 84132

  • Investigator Site 11-147

    San Antonio, Texas, 78215

  • Investigator Site 11-085

    San Antonio, Texas, 78229

  • Investigator Site 11-135

    San Diego, California, 92119

  • Investigator Site 11-086

    San Diego, California, 92161

  • Investigator Site 11-112

    Santa Ana, California, 92705

  • Investigator Site 11-094

    St Louis, Missouri, 63110

  • Investigator Site 11-081

    Staten Island, New York, 10310

  • Investigator Site 11-101

    Stockton, California, 95204

  • Investigator Site 11-021

    Stony Brook, New York, 11794

  • Investigator Site 11-161

    Sugar Land, Texas, 77479

  • Investigator Site 11-099

    Tamarac, Florida, 33321

  • Investigator Site 11-090

    Tampa, Florida, 33606

  • Investigator Site 11-163

    Tampa, Florida, 33614

  • Investigator Site 11-127

    The Bronx, New York, 10461

  • Investigator Site 11-047

    Thousand Oaks, California, 91360

  • Investigator Site 11-187

    Toledo, Ohio, 43623

  • Investigator Site 11-097

    Tucson, Arizona, 85724

  • Investigator Site 11-134

    Tullahoma, Tennessee, 37388

  • Investigator Site 11-057

    Van Nuys, California, 91401

  • Investigator Site 11-160

    Webster, Texas, 77598

  • Investigator Site 11-058

    West Hills, California, 91307

  • Investigator Site 11-022

    West Monroe, Louisiana, 71291

Other trials in United States

Spain25 sites

  • Investigator Site 37-025

    A Coruña

  • Investigator Site 37-012

    Alicante, 03010

  • Investigator Site 37-015

    Badalona, 08916

  • Investigator Site 37-003

    Barcelona, Catalonia, 08003

  • Investigator Site 37-007

    Barcelona, 08041

  • Investigator Site 37-002

    Barcelona, 08907

  • Investigator Site 37-010

    Castellon, Castellon, 12004

  • Investigator Site 37-018

    Huelva, 021005

  • Investigator Site 37-023

    Lleida, 25198

  • Investigator Site 37-004

    Madrid, 028007

  • Investigator Site 37-006

    Madrid, 028041

  • Investigator Site 37-021

    Madrid, 28006

  • Investigator Site 37-020

    Madrid, 28034

  • Investigator Site 37-026

    Madrid, 28040

  • Investigator Site 37-011

    Majadahonda, Madrid, 28222

  • Investigator Site 37-017

    Málaga, 29010

  • Investigator Site 37-001

    Manises, Valencia, 46940

  • Investigator Site 37-024

    Marbella, Malaga, 029603

  • Investigator Site 37-022

    Murcia, 300008

  • Investigator Site 37-014

    Palma de Mallorca, Balearic Islands, 07120

  • Investigator Site 37-016

    San Cristóbal de La Laguna, Tenerife, 038320

  • Investigator Site 37-005

    Santiago de Compostela, La Coruña, 015706

  • Investigator Site 37-013

    Seville, 041007

  • Investigator Site 37-009

    Valencia, 046020

  • Investigator Site 37-008

    Valencia, 4610

Other trials in Spain

Brazil23 sites

  • Investigator Site 22-007

    Aracaju, Sergipe, 49055-530

  • Investigator Site 22-011

    Belo Horizonte, Minas Gerais, 30110-934

  • Investigator Site 22-005

    Belo Horizonte, Minas Gerais, 30150-240

  • Investigator Site 22-017

    Blumenau, Santa Catarina, 89020-430

  • Investigator Site 22-023

    Brasília, Federal District, 70710-100

  • Investigator Site 22-010

    Campina Grande do Sul, Paraná, 83430-000

  • Investigator Site 22-016

    Campinas, São Paulo, 13083-970

  • Investigator Site 22-008

    Canoas, Rio Grande do Sul, 92425-900

  • Investigator Site 22-019

    Fortaleza, Ceará, 60430-370

  • Investigator Site 22-013

    Fortaleza, Ceará, 60840-285

  • Investigator Site 22-003

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Investigator Site 22-015

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Investigator Site 22-002

    Porto Alegre, Rio Grande do Sul, 90620-001

  • Investigator Site 22-009

    Porto Alegre, Rio Grande do Sul, 90840-440

  • Investigator Site 22-025

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Investigator Site 22-018

    Ribeirão Preto, São Paulo, 14051-140

  • Investigator Site 22-024

    Rio de Janeiro, 20241-180

  • Investigator Site 22-021

    Salvador, Estado de Bahia, 40170-130

  • Investigator Site 22-020

    São José do Rio Preto, São Paulo, 15015-210

  • Investigator Site 22-014

    São Paulo, 05403-000

  • Investigator Site 22-022

    São Paulo, 09080-110

  • Investigator Site 22-004

    Uberlândia, Minas Gerais, 38411-186

  • Investigator Site 22-012

    Vitória, Espírito Santo, 29043-260

Other trials in Brazil

Germany23 sites

  • Investigator Site 33-023

    Bad Oeynhausen, 32545

  • Investigator Site 33-020

    Berlin, 10789

  • Investigator Site 33-013

    Berlin, 12559

  • Investigator Site 33-015

    Bielefeld, 33604

  • Investigator Site 33-016

    Bremen, 28277

  • Investigator Site 33-011

    Coburg, Bavarian, 96450

  • Investigator Site 33-004

    Erfurt, 99097

  • Investigator Site 33-001

    Essen, 45138

  • Investigator Site 33-019

    Frankfurt, 60590

  • Investigator Site 33-007

    Frankfurt, 65929

  • Investigator Site 33-018

    Giessen, 35392

  • Investigator Site 33-008

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Investigator Site 33-002

    Halle, 06120

  • Investigator Site 33-005

    Hamburg, 20246

  • Investigator Site 33-022

    Hanover, 30625

  • Investigator Site 33-012

    Heilbronn, 74177

  • Investigator Site 33-006

    Homburg, Saarland, D-66421

  • Investigator Site 33-017

    Kiel, 24105

  • Investigator Site 33-021

    Leipzig, 04103

  • Investigator Site 33-010

    Leverkusen, 51375

  • Investigator Site 33-024

    Minden, 32429

  • Investigator Site 33-014

    Nuremberg, 90402

  • Investigator Site 33-003

    Würzburg, 97078

Other trials in Germany

France20 sites

  • Investigator Site 32-010

    Bordeaux, 33075

  • Investigator Site 32-002

    La Tronche, 38700

  • Investigator Site 32-014

    Lille, 59000

  • Investigator Site 32-020

    Lyon, 76000

  • Investigator Site 32-005

    Montpellier, 34295

  • Investigator Site 32-001

    Nancy, 54500

  • Investigator Site 32-004

    Paris, 75010

  • Investigator Site 32-008

    Paris, 75013

  • Investigator Site 32-017

    Paris, 75013

  • Investigator Site 32-007

    Paris, 75018

  • Investigator Site 32-003

    Pau, 64000

  • Investigator Site 32-015

    Poitiers, 86021

  • Investigator Site 32-013

    Reims, 51092

  • Investigator Site 32-019

    Rouen, 76031

  • Investigator Site 32-018

    Saint-Brieuc, 22000

  • Investigator Site 32-006

    Toulon, 83100

  • Investigator Site 32-012

    Toulouse, 31400

  • Investigator Site 32-009

    Tourcoing, 59200

  • Investigator Site 32-011

    Valenciennes, 59300

  • Investigator Site 32-016

    Valenciennes, 59300

Other trials in France

Argentina17 sites

  • Investigator Site 21-012

    Buenos Aires, 1425

  • Investigator Site 21-003

    Buenos Aires, C1023AAB

  • Investigator Site 21-018

    Buenos Aires, C1407GTN

  • Investigator Site 21-008

    Buenos Aires, C1430CKE

  • Investigator Site 21-006

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1093AAS

  • Investigator Site 21-007

    Ciudadela, Buenos Aires, B1702BML

  • Investigator Site 21-011

    Córdoba, Córdoba Province, 5000

  • Investigator Site 21-021

    Córdoba, Córdoba Province, X5000EVQ

  • Investigator Site 21-014

    Córdoba, Córdoba Province, X5002AOQ

  • Investigator Site 21-019

    Mar del Plata, Buenos Aires, B7602CBM

  • Investigator Site 21-020

    Ramos Mejía, Buenos Aires, B1704ETD

  • Investigator Site 21-017

    Salta, A4406BPF

  • Investigator Site 21-005

    San Luis, 5700

  • Investigator Site 21-010

    San Miguel de Tucumán, Tucumán Province, 4000

  • Investigator Site 21-004

    San Nicolás de los Arroyos, Buenos Aires, B2900DPA

  • Investigator Site 21-009

    Santa Fe, 3000

  • Investigator Site 21-015

    Villa María, Córdoba Province, 5900

Other trials in Argentina

Russia17 sites

  • Investigator Site 66-008

    Chelyabinsk, 454136

  • Investigator Site 66-014

    Izhevsk, Udmurt Republic, 426063

  • Investigator Site 66-016

    Kazan', 420033

  • Investigator Site 66-010

    Kemerovo, 650002

  • Investigator Site 66-015

    Moscow, 111539

  • Investigator Site 66-004

    Moscow, 119192

  • Investigator Site 66-011

    Moscow, 119192

  • Investigator Site 66-017

    Moscow, 124489

  • Investigator Site 66-002

    Novosibirsk, 63008

  • Investigator Site 66-005

    Penza, 440026

  • Investigator Site 66-007

    Perm, 614097

  • Investigator Site 66-012

    Petrozavodsk, 185019

  • Investigator Site 66-018

    Ryazan, 390039

  • Investigator Site 66-013

    Saint Petersburg, 198205

  • Investigator Site 66-003

    Saint Petersburg, 199106

  • Investigator Site 66-009

    Tver', 170036

  • Investigator Site 66-001

    Yekaterinburg, 620109

Other trials in Russia

Ukraine17 sites

  • Investigator Site 68-017

    Dnipro, 49027

  • Investigator Site 68-009

    Ivano-Frankivsk, 76008

  • Investigator Site 68-005

    Ivano-Frankivsk, 76018

  • Investigator Site 68-008

    Kharkiv, Novobavarskiy, 61157

  • Investigator Site 68-001

    Kharkiv, 61039

  • Investigator Site 68-011

    Kharkiv, 61058

  • Investigator Site 68-010

    Kharkiv, 61103

  • Investigator Site 68-002

    Kharkiv, 61176

  • Investigator Site 68-012

    Kyiv, 01601

  • Investigator Site 68-003

    Kyiv, 0200

  • Investigator Site 68-015

    Kyiv, 02166

  • Investigator Site 68-013

    Kyiv, 03110

  • Investigator Site 68-007

    Kyiv, 04050

  • Investigator Site 68-006

    Lviv, 79013

  • Investigator Site 68-014

    Vinnytsia, 21000

  • Investigator Site 68-016

    Zaporizhzhya, 69106

  • Investigator Site 68-004

    Zhytomyr, 10002

Other trials in Ukraine

Israel14 sites

  • Investigator Site 35-008

    Ashkelon, 78278

  • Investigator Site 35-009

    Be’er Ya‘aqov, 6093000

  • Investigator Site 35-003

    Hadera, 3810101

  • Investigator Site 35-006

    Haifa, 3109601

  • Investigator Site 35-007

    Haifa, 3109601

  • Investigator Site 35-002

    Holon, 98100

  • Investigator Site 35-005

    Jerusalem, 9103102

  • Investigator Site 35-014

    Jerusalem, 91120

  • Investigator Site 35-001

    Jerusalem, 91240

  • Investigator Site 35-010

    Nahariya, 2210001

  • Investigator Site 35-011

    Petah Tikva, 4941492

  • Investigator Site 35-013

    Ramat Gan, 5265601

  • Investigator Site 35-012

    Safed, 13100

  • Investigator Site 35-016

    Tiberias, 1520800

Other trials in Israel

Poland14 sites

  • Investigator Site 65-007

    Bialystok, 15-276

  • Investigator Site 65-014

    Katowice, 40-156

  • Investigator Site 65-012

    Kędzierzyn-Koźle, 47-200

  • Investigator Site 65-001

    Lodz, 90-549

  • Investigator Site 65-018

    Lodz, 93-513

  • Investigator Site 65-019

    Olsztyn, 10-010

  • Investigator Site 65-015

    Ostrowiec Świętokrzyski, 27-400

  • Investigator Site 65-021

    Pomorskie, 81-717

  • Investigator Site 65-003

    Poznan, 61-485

  • Investigator Site 65-020

    Poznan, 61-848

  • Investigator Site 65-008

    Rzeszów, 35-055

  • Investigator Site 65-010

    Wroclaw, 50-556

  • Investigator Site 65-005

    Wroclaw, 51-162

  • Investigator Site 65-011

    Zgierz, 95-100

Other trials in Poland

Czechia13 sites

  • Investigator Site 62-004

    Bílina, 41801

  • Investigator Site 62-019

    Brno, 65691

  • Investigator Site 62-017

    Havířov, 73601

  • Investigator Site 62-005

    Havlíčkův Brod, 58022

  • Investigator Site 62-013

    Liberec, 46001

  • Investigator Site 62-015

    Litovel, 78401

  • Investigator Site 62-010

    Mariánské Lázně, 35301

  • Investigator Site 62-018

    Náchod, 54701

  • Investigator Site 62-001

    Prague, 12808

  • Investigator Site 62-012

    Prague, 14059

  • Investigator Site 62-009

    Prague, 16902

  • Investigator Site 62-011

    Slaný, 27401

  • Investigator Site 62-016

    Uherské Hradiště, 68601

Other trials in Czechia

Netherlands13 sites

  • Investigator Site 36-002

    's-Hertogenbosch, 5223GZ

  • Investigator Site 36-012

    Amstelveen, 1186AM

  • Investigator Site 36-006

    Blaricum, 1261 AN

  • Investigator Site 36-009

    Dirksland, 3247BW

  • Investigator Site 36-015

    Dordrecht, 3318 AT

  • Investigator Site 36-007

    Ede, 6716 RP

  • Investigator Site 36-001

    Groningen, 9713 GZ

  • Investigator Site 36-013

    Helmond, 5707HA

  • Investigator Site 36-014

    Hoorn, 1624 NP

  • Investigator Site 36-003

    Rotterdam, South Holland, 3000

  • Investigator Site 36-010

    Schiedam, 3118 JH

  • Investigator Site 36-004

    Tilburg, 5042 AD

  • Investigator Site 36-011

    Utrecht, 3582 KE

Other trials in Netherlands

Georgia12 sites

  • Investigator Site 63-012

    Batumi, 6004

  • Investigator Site 63-007

    Tbilisi, 0102

  • Investigator Site 63-011

    Tbilisi, 0112

  • Investigator Site 63-004

    Tbilisi, 0131

  • Investigator Site 63-002

    Tbilisi, 0159

  • Investigator Site 63-006

    Tbilisi, 0159

  • Investigator Site 63-008

    Tbilisi, 0159

  • Investigator Site 63-010

    Tbilisi, 0159

  • Investigator Site 63-003

    Tbilisi, 0167

  • Investigator Site 63-009

    Tbilisi, 0172

  • Investigator Site 63-001

    Tbilisi, 0180

  • Investigator Site 63-005

    Tbilisi, 0186

Other trials in Georgia

United Kingdom12 sites

  • Investigator Site 39-009

    Barnsley, S75 2EP

  • Investigator Site 39-005

    Dudley, West Midlands, DY1 2HQ

  • Investigator Site 39-012

    Harlow, Essex, CM2 01QX

  • Investigator Site 39-016

    High Wycombe, HP11 2TT

  • Investigator Site 39-008

    Inverness, IV2 3JH

  • Investigator Site 39-011

    Leicester, LE3 9QP

  • Investigator Site 39-013

    Liverpool, L9 7AL

  • Investigator Site 39-015

    London, SE5 9RS

  • Investigator Site 39-010

    North Shields, NE29 8NH

  • Investigator Site 39-003

    Scunthorpe, North Lincolshire, DN15 7BH

  • Investigator Site 39-007

    Swansea, SA6 6NL

  • Investigator Site 39-004

    York, YO31 8HE

Other trials in United Kingdom

Italy11 sites

  • Investigator Site 34-005

    Ancona

  • Investigator Site 34-002

    Bergamo, 24127

  • Investigator Site 34-007

    Brescia, 25123

  • Investigator Site 34-001

    Caserta, 81100

  • Investigator Site 34-009

    Cona, 44120

  • Investigator Site 34-014

    Foggia, 71100

  • Investigator Site 34-010

    Genova, 16132

  • Investigator Site 34-004

    Milan, 20138

  • Investigator Site 34-012

    Piacenza, 29121

  • Investigator Site 34-003

    Roma, 00163

  • Investigator Site 34-013

    San Bonifacio, 37047

Other trials in Italy

Belgium10 sites

  • Investigator Site 44-005

    Aalst, B-9300

  • Investigator Site 44-009

    Brussels, 1200

  • Investigator Site 44-003

    Genk, 3600

  • Investigator Site 44-001

    Ghent, Oost Vlaanderen, 9000

  • Investigator Site 44-008

    Hasselt, 3500

  • Investigator Site 44-007

    Leuven, 3000

  • Investigator Site 44-006

    Liège, 4000

  • Investigator Site 44-002

    Mechelen, Antwerp, 2800

  • Investigator Site 44-010

    Roeselare, 8800

  • Investigator Site 44-004

    Yvoir, 5530

Other trials in Belgium

Canada9 sites

  • Investigator Site 12-008

    Cambridge, Ontario, N1R7R1

  • Investigator Site 12-009

    Greenfield Park, Quebec, J4V 2G8

  • Investigator Site 12-012

    London, Ontario, N6A 5A5

  • Investigator Site 12-010

    Newmarket, Ontario, L3Y 2P6

  • Investigator Site 12-006

    Sherbrooke, Quebec, J1G 2E8

  • Investigator Site 12-013

    St. John's, Newfoundland and Labrador, A1B3V6

  • Investigator Site 12-002

    Toronto, Ontario, M5B 1W8

  • Investigator Site 12-004

    Trois-Rivières, Quebec, G8Z 3R9

  • Investigator Site 12-005

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Mexico9 sites

  • Investigator Site 23-007

    Cuauhtémoc, Mexico City, 06090

  • Investigator Site 23-002

    Culiacán, Sinaloa, 80230

  • Investigator Site 23-012

    Guadalajara, Jalisco, 44100

  • Investigator Site 23-004

    Guadalajara, Jalisco, 44657

  • Investigator Site 23-005

    Gustavo Adolfo Madero, Mexico City, 07020

  • Investigator Site 23-011

    Oaxaca City, Oaxaca, 6800

  • Investigator Site 23-001

    Querétaro City, Querétaro, 76000

  • Investigator Site 23-010

    San Pedro Garza García, Nuevo Léon, 66278

  • Investigator Site 23-006

    Xalapa, Veracruz, 91193

Other trials in Mexico

Bulgaria8 sites

  • Investigator Site 61-003

    Burgas, 8000

  • Investigator Site 61-002

    Pleven, 5800

  • Investigator Site 61-004

    Plovdiv, 4002

  • Investigator Site 61-010

    Rousse, 7002

  • Investigator Site 61-009

    Sofia, 1233

  • Investigator Site 61-008

    Sofia, 1379

  • Investigator Site 61-005

    Sofia, 1431

  • Investigator Site 61-006

    Sofia, 1527

Other trials in Bulgaria

Serbia8 sites

  • Investigator Site 67-010

    Belgrade, 11000

  • Investigator Site 67-002

    Belgrade, 11040

  • Investigator Site 67-004

    Belgrade, 11050

  • Investigator Site 67-008

    Belgrade, 11080

  • Investigator Site 67-001

    Kamenitz, 21204

  • Investigator Site 67-005

    Niš, 18000

  • Investigator Site 67-007

    Niška Banja, 18205

  • Investigator Site 67-003

    Šabac, 15000

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Hungary7 sites

  • Investigator Site 64-010

    Budapest, 1096

  • Investigator Site 64-002

    Budapest, 1097

  • Investigator Site 64-006

    Budapest, 1122

  • Investigator Site 64-009

    Budapest, 1134

  • Investigator Site 64-001

    Kecskemét, 6000

  • Investigator Site 64-007

    Kistarcsa, 2143

  • Investigator Site 64-005

    Nyíregyháza, 4400

Other trials in Hungary

About this study

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)

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

Read the 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.

Conditions
Hyperkalemia
Being tested
Patiromer, Placebos
Keywords
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
Medical subject headings
Hyperkalemia, Renal Insufficiency, Chronic, Hypertension, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PatiromerDrug

    Also called Veltassa

    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).

  • PlacebosDrug

    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).

Study groups in NCT03888066
Study groupRoleWhat they receive
Group 1: PatiromerExperimentalSubjects will be randomized to receive a daily dose of patiromer with possible dose adjustments based on subsequent local serum potassium levels.
Receives: Drug: Patiromer
Group 2: PlaceboPlacebo comparatorSubjects will be randomized to receive a daily dose of placebo with possible dose adjustments based on subsequent local serum potassium levels.
Receives: Drug: Placebos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Serum K+ Levels From Baseline

    Adjusted mean changes in serum K+ from Baseline.

    Measured: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

Secondary outcomes (5)

  1. 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

    Measured: From Day 1/Baseline to week 90

  2. 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

    Measured: From Day 1/Baseline to week 102

  3. 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.

    Measured: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

  4. Hyperkalemia-related Hard Outcomes Endpoints

    Analyzed using Win Ratio approach with the following hierarchical components:

    1. Time to 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

    MHTE=More hyperkalemia toxicity events; MHE=More hyperkalemia events; CV=Cardiovascular

    Measured: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

  5. 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:

    1. All-cause death
    2. Occurrence of a CV hospitalization
    3. 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.

    Measured: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start24 Apr 2019
  3. Primary completion2 Sep 2021
  4. Study completion2 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03888066
Sponsor's protocol ID
PAT-CR-302
Other IDs
2018-005030-38, 2018
Acronym
DIAMOND
Status last verified
Feb 2023
First submitted
12 Mar 2019
Last updated
24 Feb 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Bayes-Genis A, Butler J, Stawowczyk E, Turner M, Lewis RD, Lloyd IT, Ramirez de Arellano A. Hyperkalemia management in heart failure and chronic kidney disease: a Spanish cost-effectiveness analysis of patiromer informed by the integrated DIAMOND trial and real-world evidence. BMC Health Serv Res. 2026 Apr 10;26(1):715. doi: 10.1186/s12913-026-14468-4.

    PubMed 41957746

  • Coats AJS, Anker SD, Lund LH, Filippatos G, Rossignol P, Pitt B, Weir MR, Kosiborod MN, Metra M, Bohm M, Ezekowitz JA, Bayes-Genis A, Mentz RJ, Ponikowski P, Senni M, Cleland JGF, Goudev A, Khintibidze I, Lindenfeld J, Merkely B, Waechter S, Budden J, Perrin A, Butler J. Patiromer for Heart Failure Medication Optimization in Patients With Current or Past Hyperkalemia: DIAMOND Subanalysis. JACC Heart Fail. 2024 Dec;12(12):2026-2037. doi: 10.1016/j.jchf.2024.08.003. Epub 2024 Sep 25.

    PubMed 39340493

  • Weir MR, Rossignol P, Pitt B, Lund LH, Coats AJS, Filippatos G, Perrin A, Waechter S, Budden J, Kosiborod M, Metra M, Boehm M, Ezekowitz JA, Bayes-Genis A, Mentz RJ, Ponikowski P, Senni M, Castro-Montes E, Nicolau JC, Parkhomenko A, Seferovic P, Cohen-Solal A, Anker SD, Butler J. Patiromer-Facilitated Renin-Angiotensin-Aldosterone System Inhibitor Utilization in Patients with Heart Failure with or without Comorbid Chronic Kidney Disease: Subgroup Analysis of DIAMOND Randomized Trial. Am J Nephrol. 2024;55(6):672-689. doi: 10.1159/000540453. Epub 2024 Aug 19.

    PubMed 39159624

  • Butler J, Anker SD, Lund LH, Coats AJS, Filippatos G, Siddiqi TJ, Friede T, Fabien V, Kosiborod M, Metra M, Pina IL, Pinto F, Rossignol P, van der Meer P, Bahit C, Belohlavek J, Bohm M, Brugts JJ, Cleland JGF, Ezekowitz J, Bayes-Genis A, Gotsman I, Goudev A, Khintibidze I, Lindenfeld J, Mentz RJ, Merkely B, Montes EC, Mullens W, Nicolau JC, Parkhomenko A, Ponikowski P, Seferovic PM, Senni M, Shlyakhto E, Cohen-Solal A, Szecsody P, Jensen K, Dorigotti F, Weir MR, Pitt B. Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial. Eur Heart J. 2022 Nov 1;43(41):4362-4373. doi: 10.1093/eurheartj/ehac401.

    PubMed 35900838

  • Bolanos JA, Seliger SL. Recurrent Hyperkalemia in Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Treatment: Stuck between a Rock and a Hard Place. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):345-347. doi: 10.2215/CJN.00950121. Epub 2021 Feb 19. No abstract available.

    PubMed 33608263

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Patiromer in people with Hyperkalemia, run by Vifor Pharma, Inc. at 415 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 415 sites in United States, Spain, Brazil, Germany, France and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Serum K+ Levels From Baseline (time frame: Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03888066, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.

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