Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND) (DIAMOND)
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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 : January 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hyperkalemia | Drug: Patiromer Drug: Placebos | Phase 3 |
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.
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 |

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). |
- 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.
- 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
- Total HF hospitalizations [ Time Frame: Through End of Study Visit, approximately 2.5 years ]Total HF hospitalizations (or equivalent in outpatient clinic)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Through End of Study Visit, approximately 2.5 years ]Patient reported outcome: Kansas City Cardiomyopathy Questionnaire (KCCQ)

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.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Head of Clinical Operations | 650-421-9500 | Diamond_Study@viforpharma.com |


United States, Alabama | |
Investigator Site 11-080 | Recruiting |
Alexander City, Alabama, United States, 35010 | |
Investigator Site 11-041 | Recruiting |
Huntsville, Alabama, United States, 35801 | |
United States, Arizona | |
Investigator Site 11-153 | Not yet recruiting |
Phoenix, Arizona, United States, 85108 | |
Investigator Site 11-097 | Not yet recruiting |
Tucson, Arizona, United States, 85724 | |
United States, California | |
Investigator Site 11-052 | Not yet recruiting |
Bakersfield, California, United States, 93308 | |
Investigator Site 11-174 | Recruiting |
Fremont, California, United States, 94538 | |
Investigator Site 11-136 | Not yet recruiting |
Fresno, California, United States, 93720 | |
Investigator Site 11-102 | Recruiting |
Huntington Beach, California, United States, 92648 | |
Investigator Site 11-162 | Not yet recruiting |
La Jolla, California, United States, 92037 | |
Investigator Site 11-048 | Recruiting |
La Mesa, California, United States, 91942 | |
Investigator Site 11-111 | Not yet recruiting |
Laguna Hills, California, United States, 92653 | |
Investigator Site 11-017 | Recruiting |
Long Beach, California, United States, 90813 | |
Investigator Site 11-128 | Recruiting |
Northridge, California, United States, 91324 | |
Investigator Site 11-035 | Recruiting |
Pasadena, California, United States, 91105 | |
Investigator Site 11-044 | Not yet recruiting |
Sacramento, California, United States, 95816 | |
Investigator Site 11-135 | Not yet recruiting |
San Diego, California, United States, 92119 | |
Investigator Site 11-086 | Not yet recruiting |
San Diego, California, United States, 92161 | |
Investigator Site 11-112 | Not yet recruiting |
Santa Ana, California, United States, 92705 | |
Investigator Site 11-101 | Not yet recruiting |
Stockton, California, United States, 95204 | |
Investigator Site 11-047 | Recruiting |
Thousand Oaks, California, United States, 91360 | |
Investigator Site 11-057 | Not yet recruiting |
Van Nuys, California, United States, 91401 | |
Investigator Site 11-058 | Recruiting |
West Hills, California, United States, 91307 | |
United States, Colorado | |
Investigator Site 11-095 | Recruiting |
Aurora, Colorado, United States, 80045 | |
Investigator Site 11-007 | Recruiting |
Littleton, Colorado, United States, 80120 | |
United States, Florida | |
Investigator Site 11-168 | Recruiting |
Altamonte Springs, Florida, United States, 32701 | |
Investigator Site 11-106 | Recruiting |
Boynton Beach, Florida, United States, 33437 | |
Investigator Site 11-020 | Recruiting |
Bradenton, Florida, United States, 34208 | |
Investigator Site 11-077 | Recruiting |
Bradenton, Florida, United States, 34209 | |
Investigator Site 11-028 | Recruiting |
Brandon, Florida, United States, 33511 | |
Investigator Site 11-011 | Recruiting |
Daytona Beach, Florida, United States, 32117 | |
Investigator Site 11-003 | Recruiting |
Doral, Florida, United States, 33166 | |
Investigator Site 11-138 | Recruiting |
Gainesville, Florida, United States, 32608 | |
Investigator Site 11-164 | Recruiting |
Green Acres, Florida, United States, 33467 | |
Investigator Site 11-139 | Recruiting |
Hialeah, Florida, United States, 33012 | |
Investigator Site 11-014 | Withdrawn |
Hialeah, Florida, United States, 33016 | |
Investigator Site 11-078 | Recruiting |
Homestead, Florida, United States, 33033 | |
Investigator Site 11-004 | Recruiting |
Jacksonville, Florida, United States, 32224-1865 | |
Investigator Site 11-114 | Recruiting |
Jacksonville, Florida, United States, 32256 | |
Investigator Site 11-179 | Recruiting |
Jacksonville, Florida, United States, 32277 | |
Investigator Site 11-122 | Recruiting |
Medley, Florida, United States, 33166 | |
Research Site 11-001 | Recruiting |
Miami Lakes, Florida, United States, 33014 | |
Research Site 11-002 | Recruiting |
Miami Lakes, Florida, United States, 33014 | |
Investigator Site 11-006 | Recruiting |
Miami, Florida, United States, 33125 | |
Investigator Site 11-115 | Recruiting |
Miami, Florida, United States, 33125 | |
Investigator Site 11-125 | Recruiting |
Miami, Florida, United States, 33144 | |
Investigator Site 11-005 | Recruiting |
Miami, Florida, United States, 33155 | |
Investigator Site 11-143 | Recruiting |
Miami, Florida, United States, 33176 | |
Investigator Site 11-032 | Recruiting |
North Miami Beach, Florida, United States, 33169 | |
Investigator Site 11-039 | Recruiting |
Ocala, Florida, United States, 34474 | |
Investigator Site 11-171 | Recruiting |
Orlando, Florida, United States, 32807 | |
Investigator Site 11-025 | Recruiting |
Orlando, Florida, United States, 32810 | |
Investigator Site 11-087 | Not yet recruiting |
Orlando, Florida, United States, 32819 | |
Investigator Site 11-177 | Recruiting |
Pembroke Pines, Florida, United States, 33026 | |
Investigator Site 11-144 | Not yet recruiting |
Pompano Beach, Florida, United States, 33064 | |
Investigator Site 11-099 | Recruiting |
Tamarac, Florida, United States, 33321 | |
Investigator Site 11-090 | Recruiting |
Tampa, Florida, United States, 33606 | |
Investigator Site 11-163 | Not yet recruiting |
Tampa, Florida, United States, 33614 | |
United States, Georgia | |
Investigator Site 11-109 | Recruiting |
Atlanta, Georgia, United States, 30303 | |
Investigator Site 11-015 | Recruiting |
Columbus, Georgia, United States, 31904 | |
Investigator Site 11-141 | Not yet recruiting |
Macon, Georgia, United States, 31201 | |
United States, Illinois | |
Investigator Site 11-031 | Recruiting |
Arlington Heights, Illinois, United States, 60005 | |
Investigator Site 11-051 | Recruiting |
Hazel Crest, Illinois, United States, 60429 | |
Investigator Site 11-063 | Recruiting |
Peoria, Illinois, United States, 61602 | |
Investigator Site 11-137 | Recruiting |
Peoria, Illinois, United States, 61614 | |
United States, Indiana | |
Investigator Site 11-117 | Not yet recruiting |
Merrillville, Indiana, United States, 46410 | |
Investigator Site 11-129 | Recruiting |
Munster, Indiana, United States, 46321 | |
Investigator Site 11-069 | Recruiting |
Richmond, Indiana, United States, 47347 | |
United States, Kentucky | |
Investigator Site 11-061 | Recruiting |
Owensboro, Kentucky, United States, 42303 | |
United States, Louisiana | |
Investigator Site 11-026 | Recruiting |
Baton Rouge, Louisiana, United States, 70808 | |
Investigator Site 11-183 | Not yet recruiting |
Opelousas, Louisiana, United States, 70570 | |
Investigator Site 11-022 | Recruiting |
West Monroe, Louisiana, United States, 71291 | |
United States, Maryland | |
Investigator Site 11-027 | Recruiting |
Baltimore, Maryland, United States, 21229 | |
Investigator Site 11-023 | Not yet recruiting |
Columbia, Maryland, United States, 21044 | |
United States, Massachusetts | |
Investigator Site 11-132 | Not yet recruiting |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Investigator Site 11-123 | Not yet recruiting |
Detroit, Michigan, United States, 48201 | |
Investigator Site 11-121 | Recruiting |
Livonia, Michigan, United States, 48154 | |
Investigator Site 11-076 | Recruiting |
Rochester, Michigan, United States, 48307 | |
United States, Mississippi | |
Investigator Site 11-068 | Not yet recruiting |
Jackson, Mississippi, United States, 39216 | |
United States, Missouri | |
Investigator Site 11-154 | Recruiting |
Kansas City, Missouri, United States, 64111 | |
Investigator Site 11-094 | Not yet recruiting |
Saint Louis, Missouri, United States, 63110 | |
Investigator Site 11-008 | Withdrawn |
Saint Louis, Missouri, United States, 63136 | |
United States, Nebraska | |
Investigator Site 11-071 | Recruiting |
Lincoln, Nebraska, United States, 68256-9797 | |
United States, Nevada | |
Investigator Site 11-049 | Not yet recruiting |
Las Vegas, Nevada, United States, 89102 | |
Investigator Site 11-145 | Not yet recruiting |
North Las Vegas, Nevada, United States, 89086 | |
United States, New Jersey | |
Investigator Site 11-088 | Recruiting |
Haddon Heights, New Jersey, United States, 08035 | |
Investigator Site 11-054 | Recruiting |
Linden, New Jersey, United States, 07036 | |
Investigator Site 11-148 | Recruiting |
New Brunswick, New Jersey, United States, 08901 | |
Investigator Site 11-107 | Not yet recruiting |
Newark, New Jersey, United States, 07102 | |
United States, New Mexico | |
Investigator Site 11-116 | Not yet recruiting |
Albuquerque, New Mexico, United States, 87109 | |
United States, New York | |
Investigator Site 11-127 | Recruiting |
Bronx, New York, United States, 10461 | |
Investigator Site 11-151 | Not yet recruiting |
Brooklyn, New York, United States, 11203-2012 | |
Investigator Site 11-126 | Not yet recruiting |
Brooklyn, New York, United States, 11234 | |
Investigator Site 11-073 | Not yet recruiting |
Buffalo, New York, United States, 14215-1145 | |
Investigator Site 11-040 | Recruiting |
Manhasset, New York, United States, 11030 | |
Investigator Site 11-053 | Recruiting |
Richmond Hill, New York, United States, 11419 | |
Investigator Site 11-093 | Not yet recruiting |
Rochester, New York, United States, 14618 | |
Investigator Site 11-081 | Not yet recruiting |
Staten Island, New York, United States, 10310 | |
Investigator Site 11-021 | Recruiting |
Stony Brook, New York, United States, 11794 | |
United States, North Carolina | |
Investigator Site 11-120 | Not yet recruiting |
Charlotte, North Carolina, United States, 28204 | |
Investigator Site 11-075 | Recruiting |
Charlotte, North Carolina, United States, 28207 | |
Investigator Site 11-019 | Recruiting |
Fayetteville, North Carolina, United States, 28304 | |
Investigator Site 11-018 | Recruiting |
Greenville, North Carolina, United States, 27834 | |
Investigator Site 11-157 | Not yet recruiting |
Lumberton, North Carolina, United States, 28358 | |
United States, Ohio | |
Investigator Site 11-149 | Recruiting |
Columbus, Ohio, United States, 43214 | |
Investigator Site 11-064 | Recruiting |
Lorain, Ohio, United States, 44053 | |
Investigator Site 11-042 | Recruiting |
Marion, Ohio, United States, 43302-6416 | |
United States, Oklahoma | |
Investigator Site 11-074 | Not yet recruiting |
Bartlesville, Oklahoma, United States, 74006 | |
Investigator Site 11-124 | Recruiting |
Oklahoma City, Oklahoma, United States, 73112 | |
United States, Oregon | |
Investigator Site 11-056 | Recruiting |
Hillsboro, Oregon, United States, 97123 | |
United States, Pennsylvania | |
Investigator Site 11-165 | Not yet recruiting |
Erie, Pennsylvania, United States, 16507 | |
Investigator Site 11-082 | Not yet recruiting |
Hershey, Pennsylvania, United States, 17033 | |
Investigator Site 11-103 | Withdrawn |
Sayre, Pennsylvania, United States, 18840 | |
United States, South Carolina | |
Investigator Site 11-110 | Recruiting |
Greenville, South Carolina, United States, 29607 | |
Investigator Site 11-098 | Not yet recruiting |
Greenwood, South Carolina, United States, 29646 | |
Investigator Site 11-119 | Recruiting |
Lancaster, South Carolina, United States, 29720 | |
Investigator Site 11-133 | Recruiting |
Rock Hill, South Carolina, United States, 29732 | |
United States, Tennessee | |
Investigator Site 11-152 | Not yet recruiting |
Chattanooga, Tennessee, United States, 37403 | |
Investigator Site 11-091 | Recruiting |
Jackson, Tennessee, United States, 38301 | |
Investigator Site 11-142 | Recruiting |
Memphis, Tennessee, United States, 38117 | |
Investigator Site 11-083 | Not yet recruiting |
Memphis, Tennessee, United States, 38138 | |
Investigator Site 11-134 | Not yet recruiting |
Tullahoma, Tennessee, United States, 37388 | |
United States, Texas | |
Investigator Site 11-104 | Recruiting |
Allen, Texas, United States, 75013 | |
Investigator Site 11-185 | Recruiting |
Allen, Texas, United States, 75013 | |
Investigator Site 11-070 | Recruiting |
Amarillo, Texas, United States, 79106 | |
Investigator Site 11-092 | Recruiting |
Dallas, Texas, United States, 75246 | |
Investigator Site 11-170 | Recruiting |
Denison, Texas, United States, 75020 | |
Investigator Site 11-060 | Recruiting |
Fort Worth, Texas, United States, 76104 | |
Investigator Site 11-072 | Recruiting |
Gonzales, Texas, United States, 78629 | |
Investigator Site 11-140 | Recruiting |
Houston, Texas, United States, 77002 | |
Investigator Site 11-009 | Recruiting |
Houston, Texas, United States, 77025 | |
Investigator Site 11-016 | Withdrawn |
Houston, Texas, United States, 77058 | |
Investigator Site 11-033 | Recruiting |
Houston, Texas, United States, 77061 | |
Investigator Site 11-089 | Recruiting |
Houston, Texas, United States, 77070 | |
Investigator Site 11-146 | Recruiting |
Houston, Texas, United States, 77077 | |
Investigator Site 11-079 | Recruiting |
Houston, Texas, United States, 77084 | |
Investigator Site 11-156 | Recruiting |
Houston, Texas, United States, 77094 | |
Investigator Site 11-034 | Recruiting |
Katy, Texas, United States, 77450 | |
Investigator Site 11-029 | Recruiting |
Lampasas, Texas, United States, 76550 | |
Investigator Site 11-010 | Recruiting |
McKinney, Texas, United States, 75069 | |
Investigator Site 11-046 | Recruiting |
McKinney, Texas, United States, 75071 | |
Investigator Site 11-055 | Recruiting |
Plano, Texas, United States, 75039 | |
Investigator Site 11-147 | Recruiting |
San Antonio, Texas, United States, 78215 | |
Investigator Site 11-085 | Not yet recruiting |
San Antonio, Texas, United States, 78229 | |
Investigator Site 11-161 | Recruiting |
Sugar Land, Texas, United States, 77479 | |
Investigator Site 11-100 | Withdrawn |
Webster, Texas, United States, 77598 | |
Investigator Site 11-160 | Recruiting |
Webster, Texas, United States, 77598 | |
United States, Virginia | |
Investigator Site 11-158 | Recruiting |
Norfolk, Virginia, United States, 23507 | |
United States, West Virginia | |
Investigator Site 11-065 | Not yet recruiting |
Morgantown, West Virginia, United States, 26506 | |
United States, Wisconsin | |
Investigator Site 11-045 | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Argentina | |
Investigator Site 21-006 | Recruiting |
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina, C1093AAS | |
Investigator Site 21-007 | Recruiting |
Ciudadela, Buenos Aires, Argentina, B1702BML | |
Investigator Site 21-020 | Recruiting |
Ramos Mejía, Buenos Aires, Argentina, B1704ETD | |
Investigator Site 21-004 | Recruiting |
San Nicolás, Buenos Aires, Argentina, B2900DPA | |
Investigator Site 21-011 | Not yet recruiting |
Córdoba, Cordoba, Argentina, 5000 | |
Investigator Site 21-014 | Recruiting |
Córdoba, Cordoba, Argentina, X5002AOQ | |
Investigator Site 21-015 | Recruiting |
Villa María, Cordoba, Argentina, 5900 | |
Investigator Site 21-010 | Not yet recruiting |
San Miguel De Tucumán, Tucuman, Argentina, 4000 | |
Investigator Site 21-003 | Recruiting |
Ciudad Autonoma de Buenos Aires, Argentina, C1023AAB | |
Investigator Site 21-018 | Recruiting |
Ciudad Autonoma de Buenos Aires, Argentina, C1407GTN | |
Investigator Site 21-008 | Recruiting |
Ciudad Autonoma de Buenos Aires, Argentina, C1430CKE | |
Belgium | |
Investigator Site 44-002 | Recruiting |
Mechelen, Antwerp, Belgium, 2800 | |
Investigator Site 44-001 | Recruiting |
Ghent, Oost Vlaanderen, Belgium, 9000 | |
Investigator Site 44-005 | Recruiting |
Aalst, Belgium, B-9300 | |
Investigator Site 44-009 | Recruiting |
Brussels, Belgium, 1200 | |
Investigator Site 44-003 | Recruiting |
Genk, Belgium, 3600 | |
Investigator Site 44-008 | Recruiting |
Hasselt, Belgium, 3500 | |
Investigator Site 44-007 | Not yet recruiting |
Leuven, Belgium, 3000 | |
Investigator Site 44-006 | Recruiting |
Liège, Belgium, 4000 | |
Investigator Site 44-004 | Recruiting |
Yvoir, Belgium, 5530 | |
Brazil | |
Investigator Site 22-021 | Recruiting |
Salvador, Bahia, Brazil, 40170-130 | |
Investigator Site 22-019 | Recruiting |
Fortaleza, Ceará, Brazil, 60430-370 | |
Investigator Site 22-013 | Not yet recruiting |
Fortaleza, Ceará, Brazil, 60840-285 | |
Investigator Site 22-023 | Not yet recruiting |
Brasília, Distrito Federal, Brazil, 70710-100 | |
Investigator Site 22-012 | Recruiting |
Vitória, Espirito Santo, Brazil, 29043-260 | |
Investigator Site 22-011 | Recruiting |
Belo Horizonte, Minas Gerais, Brazil, 30110-934 | |
Investigator Site 22-005 | Recruiting |
Belo Horizonte, Minas Gerais, Brazil, 30150-240 | |
Investigator Site 22-004 | Recruiting |
Uberlândia, Minas Gerais, Brazil, 38411-186 | |
Investigator Site 22-010 | Recruiting |
Campina Grande Do Sul, Paraná, Brazil, 83430-000 | |
Investigator Site 22-008 | Not yet recruiting |
Canoas, Rio Grande Do Sul, Brazil, 92425-900 | |
Investigator Site 22-009 | Recruiting |
Porto Alegre, Rio Grande Do Sul, Brazil, 90840-440 | |
Investigator Site 22-003 | Recruiting |
Porto Alegre, RS, Brazil, 90020-090 | |
Investigator Site 22-015 | Not yet recruiting |
Porto Alegre, RS, Brazil, 90035-903 | |
Investigator Site 22-002 | Recruiting |
Porto Alegre, RS, Brazil, 90620-001 | |
Investigator Site 22-017 | Recruiting |
Blumenau, SC, Brazil, 89020-430 | |
Investigator Site 22-007 | Recruiting |
Aracaju, Sergipe, Brazil, 49055-530 | |
Investigator Site 22-001 | Not yet recruiting |
Campinas, São Paulo, Brazil, 13060-080 | |
Investigator Site 22-016 | Not yet recruiting |
Campinas, São Paulo, Brazil, 13083-970 | |
Investigator Site 22-018 | Recruiting |
Ribeirão Preto, São Paulo, Brazil, 14051-140 | |
Investigator Site 22-020 | Recruiting |
São José Do Rio Preto, São Paulo, Brazil, 15015-210 | |
Investigator Site 22-024 | Recruiting |
Rio De Janeiro, Brazil, 20241-180 | |
Investigator Site 22-014 | Recruiting |
São Paulo, Brazil, 05403-000 | |
Investigator Site 22-022 | Recruiting |
São Paulo, Brazil, 09080-110 | |
Bulgaria | |
Investigator Site 61-003 | Recruiting |
Burgas, Bulgaria, 8000 | |
Investigator Site 61-002 | Recruiting |
Pleven, Bulgaria, 5800 | |
Investigator Site 61-004 | Not yet recruiting |
Plovdiv, Bulgaria, 4002 | |
Investigator Site 61-010 | Recruiting |
Ruse, Bulgaria, 7002 | |
Investigator Site 61-009 | Recruiting |
Sofia, Bulgaria, 1233 | |
Investigator Site 61-008 | Recruiting |
Sofia, Bulgaria, 1379 | |
Investigator Site 61-005 | Recruiting |
Sofia, Bulgaria, 1431 | |
Investigator Site 61-006 | Recruiting |
Sofia, Bulgaria, 1527 | |
Canada, Manitoba | |
Investigator Site 12-005 | Not yet recruiting |
Winnipeg, Manitoba, Canada, R2H 2A6 | |
Canada, Ontario | |
Investigator Site 12-008 | Recruiting |
Cambridge, Ontario, Canada, N1R7R1 | |
Investigator Site 12-012 | Not yet recruiting |
London, Ontario, Canada, N6A 5A5 | |
Investigator Site 12-010 | Not yet recruiting |
Newmarket, Ontario, Canada, L3Y 2P6 | |
Canada, Quebec | |
Investigator Site 12-009 | Recruiting |
Greenfield Park, Quebec, Canada, J4V 2G8 | |
Czechia | |
Investigator Site 62-019 | Not yet recruiting |
Brno, Czechia, 65691 | |
Investigator Site 62-004 | Recruiting |
Bílina, Czechia, 41801 | |
Investigator Site 62-005 | Not yet recruiting |
Havlíčkův Brod, Czechia, 58022 | |
Investigator Site 62-017 | Recruiting |
Havířov, Czechia, 73601 | |
Investigator Site 62-006 | Not yet recruiting |
Kolín, Czechia, 28002 | |
Investigator Site 62-013 | Recruiting |
Liberec, Czechia, 46001 | |
Investigator Site 62-015 | Not yet recruiting |
Litovel, Czechia, 78401 | |
Investigator Site 62-010 | Recruiting |
Mariánské Lázně, Czechia, 35301 | |
Investigator Site 62-018 | Recruiting |
Náchod, Czechia, 54701 | |
Investigator Site 62-001 | Recruiting |
Praha, Czechia, 12808 | |
Investigator Site 62-011 | Recruiting |
Slaný, Czechia, 27401 | |
Investigator Site 62-016 | Recruiting |
Uherské Hradiště, Czechia, 68601 | |
France | |
Investigator Site 32-010 | Recruiting |
Bordeaux, France, 33075 | |
Investigator Site 32-002 | Recruiting |
La Tronche, France, 38700 | |
Investigator Site 32-014 | Recruiting |
Lille, France, 59000 | |
Investigator Site 32-005 | Recruiting |
Montpellier, France, 34295 | |
Investigator Site 32-001 | Recruiting |
Nancy, France, 54500 | |
Investigator Site 32-004 | Recruiting |
Paris, France, 75010 | |
Investigator Site 32-008 | Recruiting |
Paris, France, 75013 | |
Investigator Site 32-017 | Recruiting |
Paris, France, 75013 | |
Investigator Site 32-007 | Recruiting |
Paris, France, 75018 | |
Investigator Site 32-003 | Recruiting |
Pau, France, 64000 | |
Investigator Site 32-015 | Recruiting |
Poitiers, France, 86021 | |
Investigator Site 32-013 | Recruiting |
Reims, France, 51092 | |
Investigator Site 32-019 | Not yet recruiting |
Rouen, France, 76031 | |
Investigator Site 32-018 | Not yet recruiting |
Saint-Brieuc, France, 22000 | |
Investigator Site 32-006 | Recruiting |
Toulon, France, 83100 | |
Investigator Site 32-012 | Recruiting |
Toulouse, France, 31400 | |
Investigator Site 32-009 | Recruiting |
Tourcoing, France, 59200 | |
Investigator Site 32-011 | Recruiting |
Valenciennes, France, 59300 | |
Investigator Site 32-016 | Recruiting |
Valenciennes, France, 59300 | |
Georgia | |
Investigator Site 63-012 | Recruiting |
Batumi, Georgia, 6004 | |
Investigator Site 63-007 | Recruiting |
Tbilisi, Georgia, 0102 | |
Investigator Site 63-011 | Recruiting |
Tbilisi, Georgia, 0112 | |
Investigator Site 63-004 | Recruiting |
Tbilisi, Georgia, 0131 | |
Investigator Site 63-002 | Recruiting |
Tbilisi, Georgia, 0159 | |
Investigator Site 63-006 | Recruiting |
Tbilisi, Georgia, 0159 | |
Investigator Site 63-008 | Recruiting |
Tbilisi, Georgia, 0159 | |
Investigator Site 63-010 | Recruiting |
Tbilisi, Georgia, 0159 | |
Investigator Site 63-003 | Recruiting |
Tbilisi, Georgia, 0167 | |
Investigator Site 63-009 | Recruiting |
Tbilisi, Georgia, 0172 | |
Investigator Site 63-001 | Recruiting |
Tbilisi, Georgia, 0180 | |
Investigator Site 63-005 | Recruiting |
Tbilisi, Georgia, 0186 | |
Germany | |
Investigator Site 33-011 | Recruiting |
Coburg, Bavarian, Germany, 96450 | |
Investigator Site 33-008 | Recruiting |
Greifswald, Mecklenburg-Vorpommern, Germany, 17475 | |
Investigator Site 33-006 | Recruiting |
Homburg, Saar, Germany, D-66421 | |
Investigator Site 33-023 | Not yet recruiting |
Bad Oeynhausen, Germany, 32545 | |
Investigator Site 33-020 | Recruiting |
Berlin, Germany, 10789 | |
Investigator Site 33-013 | Recruiting |
Berlin, Germany, 12559 | |
Investigator Site 33-015 | Recruiting |
Bielefeld, Germany, 33604 | |
Investigator Site 33-016 | Not yet recruiting |
Bremen, Germany, 28277 | |
Investigator Site 33-004 | Recruiting |
Erfurt, Germany, 99097 | |
Investigator Site 33-001 | Not yet recruiting |
Essen, Germany, 45138 | |
Investigator Site 33-019 | Recruiting |
Frankfurt, Germany, 60590 | |
Investigator Site 33-007 | Recruiting |
Frankfurt, Germany, 65929 | |
Investigator Site 33-018 | Not yet recruiting |
Gießen, Germany, 35392 | |
Investigator Site 33-002 | Recruiting |
Halle, Germany, 06120 | |
Investigator Site 33-005 | Not yet recruiting |
Hamburg, Germany, 20246 | |
Investigator Site 33-022 | Not yet recruiting |
Hanover, Germany, 30625 | |
Investigator Site 33-012 | Recruiting |
Heilbronn, Germany, 74177 | |
Investigator Site 33-017 | Not yet recruiting |
Kiel, Germany, 24105 | |
Investigator Site 33-021 | Recruiting |
Leipzig, Germany, 04103 | |
Investigator Site 33-010 | Recruiting |
Leverkusen, Germany, 51375 | |
Investigator Site 33-024 | Not yet recruiting |
Minden, Germany, 32429 | |
Investigator Site 33-014 | Recruiting |
Nürnberg, Germany, 90402 | |
Investigator Site 33-003 | Recruiting |
Würzburg, Germany, 97078 | |
Hungary | |
Investigator Site 64-004 | Withdrawn |
Baja, Hungary, 65000 | |
Investigator Site 64-010 | Not yet recruiting |
Budapest, Hungary, 1096 | |
Investigator Site 64-002 | Recruiting |
Budapest, Hungary, 1097 | |
Investigator Site 64-006 | Recruiting |
Budapest, Hungary, 1122 | |
Investigator Site 64-009 | Recruiting |
Budapest, Hungary, 1134 | |
Investigator Site 64-011 | Recruiting |
Budapest, Hungary, 1135 | |
Investigator Site 64-001 | Recruiting |
Kecskemét, Hungary, 6000 | |
Investigator Site 64-007 | Recruiting |
Kistarcsa, Hungary, 2143 | |
Investigator Site 64-008 | Recruiting |
Miskolc, Hungary, 3526 | |
Investigator Site 64-005 | Recruiting |
Nyiregyhaza, Hungary, 4400 | |
Israel | |
Investigator Site 35-008 | Recruiting |
Ashqelon, Israel, 78278 | |
Investigator Site 35-009 | Recruiting |
Be'er Ya'aqov, Israel, 6093000 | |
Investigator Site 35-003 | Recruiting |
Hadera, Israel, 3810101 | |
Investigator Site 35-006 | Recruiting |
Haifa, Israel, 3109601 | |
Investigator Site 35-007 | Recruiting |
Haifa, Israel, 3109601 | |
Investigator Site 35-002 | Recruiting |
H̱olon, Israel, 98100 | |
Investigator Site 35-005 | Recruiting |
Jerusalem, Israel, 9103102 | |
Investigator Site 35-014 | Recruiting |
Jerusalem, Israel, 91120 | |
Investigator Site 35-001 | Recruiting |
Jerusalem, Israel, 91240 | |
Investigator Site 35-010 | Recruiting |
Nahariya, Israel, 2210001 | |
Investigator Site 35-015 | Recruiting |
Nazareth, Israel, 16100 | |
Investigator Site 35-011 | Recruiting |
Petah tikva, Israel, 4941492 | |
Investigator Site 35-013 | Recruiting |
Ramat Gan, Israel, 5265601 | |
Investigator Site 35-012 | Recruiting |
Safed, Israel, 13100 | |
Investigator Site 35-016 | Recruiting |
Tiberias, Israel, 1520800 | |
Italy | |
Investigator Site 34-005 | Not yet recruiting |
Ancona, Italy | |
Investigator Site 34-002 | Recruiting |
Bergamo, Italy, 24127 | |
Investigator Site 34-007 | Not yet recruiting |
Brescia, Italy, 25123 | |
Investigator Site 34-001 | Not yet recruiting |
Caserta, Italy, 81100 | |
Investigator Site 34-009 | Not yet recruiting |
Cona, Italy, 44120 | |
Investigator Site 34-004 | Recruiting |
Milano, Italy, 20138 | |
Investigator Site 34-012 | Not yet recruiting |
Piacenza, Italy, 29121 | |
Investigator Site 34-003 | Recruiting |
Roma, Italy, 00163 | |
Mexico | |
Investigator Site 23-007 | Not yet recruiting |
Cuauhtémoc, Ciudad De Mexico, Mexico, 06090 | |
Investigator Site 23-005 | Recruiting |
Delegación Gustavo A. Madero, Ciudad De Mexico, Mexico, 07020 | |
Investigator Site 23-004 | Recruiting |
Guadalajara, Jalisco, Mexico, 44657 | |
Investigator Site 23-010 | Recruiting |
San Pedro Garza Garcia, Nuevo Léon, Mexico, 66278 | |
Investigator Site 23-011 | Not yet recruiting |
Oaxaca de Juarez, Oaxaca, Mexico, 6800 | |
Investigator Site 23-001 | Recruiting |
Santiago De Querétaro, Querétaro, Mexico, 76000 | |
Investigator Site 23-002 | Recruiting |
Culiacán, Sinaloa, Mexico, 80230 | |
Investigator Site 23-006 | Recruiting |
Xalapa, Veracruz, Mexico, 91193 | |
Netherlands | |
Investigator Site 36-003 | Recruiting |
Rotterdam, South Holland, Netherlands, 3000 | |
Investigator Site 36-002 | Recruiting |
's-Hertogenbosch, Netherlands, 5223GZ | |
Investigator Site 36-012 | Recruiting |
Amstelveen, Netherlands, 1186AM | |
Investigator Site 36-006 | Recruiting |
Blaricum, Netherlands, 1261 AN | |
Investigator Site 36-009 | Not yet recruiting |
Dirksland, Netherlands, 3247BW | |
Investigator Site 36-015 | Recruiting |
Dordrecht, Netherlands, 3318 AT | |
Investigator Site 36-007 | Recruiting |
Ede, Netherlands, 6716 RP | |
Investigator Site 36-001 | Recruiting |
Groningen, Netherlands, 9713 GZ | |
Investigator Site 36-013 | Recruiting |
Helmond, Netherlands, 5707HA | |
Investigator Site 36-014 | Recruiting |
Hoorn, Netherlands, 1624 NP | |
Investigator Site 36-010 | Recruiting |
Schiedam, Netherlands, 3118 JH | |
Investigator Site 36-004 | Recruiting |
Tilburg, Netherlands, 5042 AD | |
Investigator Site 36-011 | Not yet recruiting |
Utrecht, Netherlands, 3582 KE | |
Poland | |
Investigator Site 65-007 | Recruiting |
Białystok, Poland, 15-276 | |
Investigator Site 65-014 | Recruiting |
Katowice, Poland, 40-156 | |
Investigator Site 65-016 | Withdrawn |
Kraków, Poland, 30-149 | |
Investigator Site 65-002 | Recruiting |
Kraków, Poland, 31-637 | |
Investigator Site 65-012 | Recruiting |
Kędzierzyn-Koźle, Poland, 47-200 | |
Investigator Site 65-019 | Recruiting |
Olsztyn, Poland, 10-010 | |
Investigator Site 65-015 | Recruiting |
Ostrowiec Świętokrzyski, Poland, 27-400 | |
Investigator Site 65-013 | Recruiting |
Oława, Poland, 55-200 | |
Investigator Site 65-021 | Recruiting |
Pomorskie, Poland, 81-717 | |
Investigator Site 65-003 | Recruiting |
Poznań, Poland, 61-485 | |
Investigator Site 65-020 | Recruiting |
Poznań, Poland, 61-848 | |
Investigator Site 65-008 | Recruiting |
Rzeszów, Poland, 35-055 | |
Investigator Site 65-009 | Recruiting |
Tychy, Poland, 43-100 | |
Investigator Site 65-010 | Recruiting |
Wrocław, Poland, 50-556 | |
Investigator Site 65-005 | Recruiting |
Wrocław, Poland, 51-162 | |
Investigator Site 65-011 | Recruiting |
Zgierz, Poland, 95-100 | |
Investigator Site 65-001 | Recruiting |
Łódź, Poland, 90-549 | |
Investigator Site 65-018 | Recruiting |
Łódź, Poland, 93-513 | |
Russian Federation | |
Investigator Site 66-014 | Recruiting |
Izhevsk, Udmurt Republic, Russian Federation, 426063 | |
Investigator Site 66-008 | Recruiting |
Chelyabinsk, Russian Federation, 454136 | |
Investigator Site 66-001 | Recruiting |
Ekaterinburg, Russian Federation, 620109 | |
Investigator Site 66-016 | Not yet recruiting |
Kazan, Russian Federation, 420033 | |
Investigator Site 66-010 | Recruiting |
Kemerovo, Russian Federation, 650002 | |
Investigator Site 66-015 | Not yet recruiting |
Moscow, Russian Federation, 111539 | |
Investigator Site 66-004 | Recruiting |
Moscow, Russian Federation, 119192 | |
Investigator Site 66-011 | Not yet recruiting |
Moscow, Russian Federation, 119192 | |
Investigator Site 66-017 | Not yet recruiting |
Moscow, Russian Federation, 124489 | |
Investigator Site 66-002 | Recruiting |
Novosibirsk, Russian Federation, 63008 | |
Investigator Site 66-005 | Recruiting |
Penza, Russian Federation, 440026 | |
Investigator Site 66-007 | Withdrawn |
Perm, Russian Federation, 614097 | |
Investigator Site 66-012 | Not yet recruiting |
Petrozavodsk, Russian Federation, 185019 | |
Investigator Site 66-018 | Not yet recruiting |
Ryazan', Russian Federation, 390039 | |
Investigator Site 66-013 | Not yet recruiting |
Saint Petersburg, Russian Federation, 198205 | |
Investigator Site 66-003 | Not yet recruiting |
Saint Petersburg, Russian Federation, 199106 | |
Investigator Site 66-009 | Recruiting |
Tver, Russian Federation, 170036 | |
Serbia | |
Investigator Site 67-010 | Not yet recruiting |
Belgrade, Serbia, 11000 | |
Investigator Site 67-002 | Recruiting |
Belgrade, Serbia, 11040 | |
Investigator Site 67-004 | Recruiting |
Belgrade, Serbia, 11050 | |
Investigator Site 67-007 | Recruiting |
Niška Banja, Serbia, 18205 | |
Investigator Site 67-005 | Not yet recruiting |
Niš, Serbia, 18000 | |
Investigator Site 67-001 | Recruiting |
Sremska Kamenica, Serbia, 21204 | |
Investigator Site 67-006 | Not yet recruiting |
Zaječar, Serbia, 19000 | |
Investigator Site 67-003 | Not yet recruiting |
Šabac, Serbia, 15000 | |
Spain | |
Investigator Site 37-014 | Recruiting |
Palma De Mallorca, Baleares, Spain, 07120 | |
Investigator Site 37-010 | Not yet recruiting |
Castellón De La Plana, Castellon, Spain, 12004 | |
Investigator Site 37-003 | Recruiting |
Barcelona, Cataluña, Spain, 08003 | |
Investigator Site 37-005 | Recruiting |
Santiago De Compostela, La Coruña, Spain, 015706 | |
Investigator Site 37-011 | Recruiting |
Majadahonda, Madrid, Spain, 28222 | |
Investigator Site 37-024 | Recruiting |
Marbella, Malaga, Spain, 029603 | |
Investigator Site 37-016 | Not yet recruiting |
La Laguna, Tenerife, Spain, 038320 | |
Investigator Site 37-001 | Recruiting |
Manises, Valencia, Spain, 46940 | |
Investigator Site 37-012 | Recruiting |
Alicante, Spain, 03010 | |
Investigator Site 37-015 | Recruiting |
Badalona, Spain, 08916 | |
Investigator Site 37-007 | Recruiting |
Barcelona, Spain, 08041 | |
Investigator Site 37-002 | Recruiting |
Barcelona, Spain, 08907 | |
Investigator Site 37-018 | Recruiting |
Huelva, Spain, 021005 | |
Investigator Site 37-025 | Recruiting |
La Coruña, Spain | |
Investigator Site 37-023 | Not yet recruiting |
Lleida, Spain, 25198 | |
Investigator Site 37-004 | Recruiting |
Madrid, Spain, 028007 | |
Investigator Site 37-006 | Recruiting |
Madrid, Spain, 028041 | |
Investigator Site 37-021 | Not yet recruiting |
Madrid, Spain, 28006 | |
Investigator Site 37-020 | Recruiting |
Madrid, Spain, 28034 | |
Investigator Site 37-026 | Recruiting |
Madrid, Spain, 28040 | |
Investigator Site 37-022 | Not yet recruiting |
Murcia, Spain, 300008 | |
Investigator Site 37-017 | Not yet recruiting |
Málaga, Spain, 29010 | |
Investigator Site 37-013 | Recruiting |
Sevilla, Spain, 041007 | |
Investigator Site 37-009 | Recruiting |
Valencia, Spain, 046020 | |
Investigator Site 37-008 | Recruiting |
Valencia, Spain, 4610 | |
Ukraine | |
Investigator Site 68-008 | Recruiting |
Kharkiv, Novobavarskiy, Ukraine, 61157 | |
Investigator Site 68-017 | Recruiting |
Dnipro, Ukraine, 49027 | |
Investigator Site 68-009 | Recruiting |
Ivano-Frankivs'k, Ukraine, 76008 | |
Investigator Site 68-005 | Recruiting |
Ivano-Frankivs'k, Ukraine, 76018 | |
Investigator Site 68-001 | Recruiting |
Kharkiv, Ukraine, 61039 | |
Investigator Site 68-011 | Recruiting |
Kharkiv, Ukraine, 61058 | |
Investigator Site 68-010 | Recruiting |
Kharkiv, Ukraine, 61103 | |
Investigator Site 68-002 | Recruiting |
Kharkiv, Ukraine, 61176 | |
Investigator Site 68-012 | Recruiting |
Kyiv, Ukraine, 01601 | |
Investigator Site 68-003 | Recruiting |
Kyiv, Ukraine, 0200 | |
Investigator Site 68-015 | Recruiting |
Kyiv, Ukraine, 02166 | |
Investigator Site 68-013 | Recruiting |
Kyiv, Ukraine, 03110 | |
Investigator Site 68-007 | Recruiting |
Kyiv, Ukraine, 04050 | |
Investigator Site 68-006 | Recruiting |
Lviv, Ukraine, 79013 | |
Investigator Site 68-014 | Recruiting |
Vinnytsia, Ukraine, 21000 | |
Investigator Site 68-016 | Recruiting |
Zaporizhzhya, Ukraine, 69106 | |
Investigator Site 68-004 | Recruiting |
Zhytomyr, Ukraine, 10002 | |
United Kingdom | |
Investigator Site 39-012 | Not yet recruiting |
Harlow, Essex, United Kingdom, CM2 01QX | |
Investigator Site 39-003 | Recruiting |
Scunthorpe, North Lincolshire, United Kingdom, DN15 7BH | |
Investigator Site 39-005 | Not yet recruiting |
Dudley, West Midlands, United Kingdom, DY1 2HQ | |
Investigator Site 39-009 | Not yet recruiting |
Barnsley, United Kingdom, S75 2EP | |
Investigator Site 39-006 | Withdrawn |
Chesterfield, United Kingdom, S44 5DX | |
Investigator Site 39-016 | Recruiting |
High Wycombe, United Kingdom, HP11 2TT | |
Investigator Site 39-008 | Not yet recruiting |
Inverness, United Kingdom, IV2 3JH | |
Investigator Site 39-011 | Not yet recruiting |
Leicester, United Kingdom, LE3 9QP | |
Investigator Site 39-013 | Not yet recruiting |
Liverpool, United Kingdom, L9 7AL | |
Investigator Site 39-015 | Not yet recruiting |
London, United Kingdom, SE5 9RS | |
Investigator Site 39-014 | Not yet recruiting |
London, United Kingdom, SW17 0QT | |
Investigator Site 39-010 | Not yet recruiting |
North Shields, United Kingdom, NE29 8NH | |
Investigator Site 39-007 | Not yet recruiting |
Swansea, United Kingdom, SA6 6NL | |
Investigator Site 39-004 | Not yet recruiting |
York, United Kingdom, YO31 8HE |
Study Director: | Udo-Michael Goehring, MD | Vifor Pharma |
Responsible Party: | Relypsa, Inc. |
ClinicalTrials.gov Identifier: | NCT03888066 |
Other Study ID Numbers: |
Relypsa |
First Posted: | March 25, 2019 Key Record Dates |
Last Update Posted: | January 5, 2021 |
Last Verified: | January 2021 |
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. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Heart Failure Hyperkalemia Heart Diseases |
Cardiovascular Diseases Water-Electrolyte Imbalance Metabolic Diseases |