The purpose of this study is to assess the effects of RLY5016 on serum potassium in heart
failure patients. This study will also assess the safety and tolerability of RLY5016 in
heart failure patients.
Inclusion Criteria:
- Heart failure patients clinically indicated to receive spironolactone therapy, with
serum potassium levels of 4. 3 - 5. 1 mEq/L AND chronic kidney disease (GFR <60 mL/min)
OR documented history of hyperkalemia within the last 6 months
- Females of child-bearing potential must be non-lactating, must have a negative serum
pregnancy test at screening, and must have used a highly effective form of
contraception for at least 3 months before study drug administration, during the
study, and for one month after study completion
- Male patients and/or their female partners of child-bearing potential must use a
highly effective form of contraception during the study and for 3 months after study
completion
- Must sign informed consent document
Exclusion Criteria:
- History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders
or major gastrointestinal surgery
- Uncorrected hemodynamically significant primary valvular disease, known obstructive
or restrictive cardiomyopathy, uncontrolled or hemodynamically unstable arrhythmia
- Coronary-artery bypass graft, percutaneous intervention (e. g. cardiac,
cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 3
months prior to baseline or anticipated need during study participation
- Heart transplant recipient, or anticipated need for transplant during study
participation
- Any of the following events having occurred within 3 months prior to baseline:
unstable angina as judged by the Investigator, unresolved acute coronary syndrome,
transient ischemic attack or stroke
- Current dialysis patient, or anticipated need for dialysis during study participation
- Prior kidney transplant, or anticipated need for transplant during study
participation
- Metastatic, late-stage or end-stage cancer with < 12 months life expectancy
- History of alcoholism or drug/chemical abuse within 1 year
- QTcB interval > 500 msec (Bazett's correction formula)
- Sustained systolic blood pressure > 170 or < 90 mmHg
- Liver enzymes (ALT, AST) > 3 times upper limit of normal
- Use of oral cardiac medications (including loop and thiazide diuretics) that have not
been stable for at least 21 days prior to baseline and are not anticipated to remain
stable during study participation
- Use of any IV cardiac medications within 21 days prior to baseline, or their
anticipated need during study participation.
- Current use of polymer-based drugs (e. g. Renagel, Kayexalate, Welchol, Colestid),
other phosphate binders or potassium binders, calcium supplements, antacids (eg TUMS,
Maalox), or their anticipated need during study participation
- Use of aldosterone antagonist in the last 30 days prior to baseline, unless was
discontinued due to hyperkalemia
- Use of potassium sparing medication and/or potassium supplements in the last 30 days
prior to baseline
- Use of any investigational medication, 30 days or 5 half-lives whichever is longer,
prior to baseline
- Patients who have taken investigational product in this study, or a previous RLY5016
study
- Inability to consume the study medication, or, in the opinion of the Investigator,
inability to comply with the protocol
- In the opinion of the Investigator, any medical condition, uncontrolled systemic
disease, serious intercurrent illness, or extenuating circumstance occurring or
persisting, within 30 days prior to baseline, that would significantly decrease study
compliance or jeopardize the safety of the patient or affect the validity of the
trial results
Laura Craft, RN, PhD, Phone: 800-730-5779, Ext: 2180, Email: l.craft@medpace.com
Faculty Hospital Hradec Králové, Hradec Králové 500 05, Czech Republic; Recruiting
Radek Pudil, MD Phd, Phone: 420 777 210367
Faculty Hospital, Internal Cardiology Clinic,, Brno 62500, Czech Republic; Recruiting
Jindrich Spinar, MD, Phone: 420 532 232601
Klinika Kardiologie IKEM, Prague 14059, Czech Republic; Recruiting
Ivan Malek, MD, Phone: 420 261 365010
Interni Klinika Kardiologie a Angiologie, Prague 12800, Czech Republic; Recruiting
Jan Belohlavek, MD, Phone: 420724371594
Diagnostic Services Clinic LTD, Tblisi 0179, Georgia; Recruiting
Tamaz Shaburishvili, MD PhD, Phone: 995 32 251000
Multiprofile Clinical Hospital of Tblisi #2, LTD, Tblisi 0164, Georgia; Recruiting
Kakhi Paposhvili, MD, Phone: 995 32 95 42 66
Cardio-Reaninmation Centre LTD, Tblisi 0141, Georgia; Recruiting
Bondo Kobulia, MD PhD, Phone: 995 32 60 53 73
JSC National Center of Therapy, Tblisi 0159, Georgia; Recruiting
Vakhtang Chumburidze, MD PhD, Phone: 995 32 251000
EOPL Tbilisi State Medical University Alexandre Aladashvili University Clinic, Tblisi 0102, Georgia; Recruiting
Irakli Khintibidze, MD PhD, Phone: 995 32 95 05 18
Charite - Universitatsmedizen Berlin, Berlin D-13353, Germany; Recruiting
Wilhelm Haverkamp, MD, PhD, Phone: 49 (0)30450553722
Kardiologische Schwerpunktprxis, Heidelberg 69120, Germany; Recruiting
Mohammed Natour, MD, Phone: 4962211409605
Kardiologie Klinik J.W Goethe Universitat, Frankfurt 60590, Germany; Recruiting
Birgit Assmus, MD, Phone: 49 6963 014975
University of Goettingen Georg-August-Universitaet Kardiologie und Pneumologie, Goettingen 37075, Germany; Recruiting
Rolf Wachter, MD, Phone: 49551398920
Katedra i Klinika Kardiologii, Lublin 20-954, Poland; Recruiting
Andrzej Wysokinski, MD, Phone: 48 81 72 44 151
Instytut Kardiologii II, Klinika Choroby Wiencowej, Warsaw 02637, Poland; Recruiting
Hanna Szwed, MD, Phone: 4822 343 40 50
Department of Cardiology, Medical Univeristy of Lodz, Lodz 91-425, Poland; Recruiting
Jaroslaw Drozdz, MD, Phone: 48 426364471
Municipal Healthcare Institute Kemerovo Cardiology Dispensary, Kemerovo 650002, Russian Federation; Recruiting
Olga Barbarash, MD, PhD, Phone: 7-3842643279
Federal State Institution Outpatient Clinic #3, Moscow 129090, Russian Federation; Recruiting
Alexey Blokhin, MD, PhD, Phone: 007 (495) 680-75-55
State Healthcare Institution of Moscow - City Hospital #15, Moscow 111539, Russian Federation; Recruiting
Ivan Gordeev, MD, PhD, Phone: 74959187284
State Institution Scientific Research Institute of Cardiology Tomsk, Tomsk 634012, Russian Federation; Recruiting
Valentin Markov, MD, PhD, Phone: 7(382)2-553689
Municipal Healthcare Institution - City Hospital #1, Barnaul 656099, Russian Federation; Recruiting
Alexander Tomofeev, MD, PhD, Phone: 7 (3852) 36 46 55
Federal Centre of heart, blood, endocrinology n.a. Almazov, St Petersburg 197341, Russian Federation; Recruiting
Alexey Panov, MD PhD, Phone: 7812 940 9908
St Petersburg State Healthcare Institution, Pokrovskaya City Hospital, St Petersburg 199106, Russian Federation; Recruiting
Alexander Vishnevsky, MD, Phone: 7 812 3220420
St Petersburg State Healthcare Institution, City Hospital #15, St Petersburg 198205, Russian Federation; Recruiting
Boris Goloshchekin, MD Phd, Phone: 7 921 9535875
Federal State Institution Research Institute of Physical & Chemical Medicine of Roszdraz, Moscow 111020, Russian Federation; Recruiting
Nikolay Gratsiansky, Phone: 7 499 261 4644
State Healthcare Institution of Moscow City Hospital #40, Moscow 129301, Russian Federation; Recruiting
Evgenia Akatova, MD PhD, Phone: 7 495 646 6492
Institute of Gerontology, AMS of Ukraine, Kiev 04114, Ukraine; Recruiting
Viktoriia Lishnevska, MD PhD, Phone: 48 81 72 44 151
City Clinical Emergency Hospital, Therapy Department, Kharkiv 61018, Ukraine; Recruiting
Olga Godlevska, MD PhD, Phone: 380 57 343 1298
Malaya Institute of Therapy, AMS of Ukraine, Kharkiv 61039, Ukraine; Recruiting
Yuriy Rudyk, MD DSc, Phone: 380 57 370 6105
Dnipropetrovsk City Clinical Hospital No. 9 Cardiology Department, Dnipropetrovsk 49023, Ukraine; Recruiting
Tetyana Pertseva, MD PhD, Phone: 380 562 231394
Kharkiv City Clinical Hospital No. 8, Department of Cardiology and Functional Diagnostics, Kharkiv 61176, Ukraine; Recruiting
Vira Tseluyko, MD PhD, Phone: 380 5710 9881
National Medical University O.O. Bogomolets, Kiev 01601, Ukraine; Recruiting
Kateryna Amosova, MD PhD, Phone: 380 44 5457128
National Scientific Center - Strazhesko Institute of Cardiology, Kiev 03680, Ukraine; Recruiting
Yeugeniya Svyshchenko, MD PhD, Phone: 38 04 42497044
National Scientific Center - Strazhesko Institute of Cardiology, Kiev 03680, Ukraine; Recruiting
Leonid Voronkov, md PhD, Phone: 38 044 275 5387
Southwest Heart, Tucson, Arizona 85710, United States; Withdrawn
Sutter Transplant Heart Specialty Clinic, Sacramento, California 95819, United States; Recruiting
John Chin, MD, Phone: 916-733-8133
Brevard Cardiovascular Research Associates, Rockledge, Florida 32955, United States; Recruiting
Khalid Sheikh, MD, Phone: 321-434-6650
University of Florida Health Science Center at Jacksonville, Jacksonville, Florida 32209, United States; Recruiting
Douglas Chapman, MD, Phone: 902-244-2092
Charlotte Cardiovascular Institute, Port Charlotte, Florida 33952, United States; Recruiting
David Hotchkiss, MD, Phone: 941-629-5356
South Florida Research Group LLC, Miami, Florida 33176, United States; Recruiting
Jonathan Roberts, MD, Phone: 305-279-4500
Florida Cardiovascular Institute, Tampa, Florida 33609, United States; Recruiting
Joel Fernandez, MD, Phone: 813-353-0865
WellStar Cardiovascular Medicine, Marietta, Georgia 30060, United States; Recruiting
Amar Patel, MD, Phone: 770-424-6893
Methodist Medical Group Cardiology, Peoria, Illinois 61606, United States; Recruiting
Alexander Adler, MD, Phone: 309-672-4670
Maine Research Associates, Auburn, Maine 04210, United States; Withdrawn
Southern Maine Medical Center PrimeCare Physician Services, Biddeford, Maine 04005, United States; Recruiting
Edward Quinlan, MD, Phone: 207-282-3666
Minneapolis VA Medical Center, Minneapolis, Minnesota 55417, United States; Recruiting
Inder Anand, MD, Phone: 612-467-2171, Email: anand001@umn.edu
The Valley Hospital, Ridgewood, New Jersey 07450, United States; Recruiting
Michael Kesselbrenner, MD, Phone: 201-689-9400
Buffalo Heart Group, Buffalo, New York 14215, United States; Recruiting
Marie Iacona, MD, Phone: 716-635-2966
Northport VAMC Medical Services, Northport, New York 11768, United States; Recruiting
Joanne Holland, MD, Phone: 631-261-4400, Ext: 2169
University of Rochester Medical Center, Rochester, New York 14642, United States; Recruiting
John Bisognano, MD, PhD, Phone: 585-273-0073
Lindner Center for Research and Education at the Christ Hospital, Cincinnati, Ohio 45219, United States; Recruiting
Santosh Menon, MD, Phone: 513-721-8881
Greater Cincinatti Cardiovascular Consultants, Inc, Fairfield, Ohio 45014, United States; Recruiting
Lynne Wagoner, MD, Phone: 513-751-4222
Davis Heart & Lung Research Institute, Columbus, Ohio 43210, United States; Recruiting
Ragavendra Baliga, MD, Phone: 614-247-7730
University of Cincinatti, Cincinatti, Ohio 45267, United States; Recruiting
Stephanie Dunlap, DO, Phone: 513-558-3712
Hahnemann University Hospital / Tenet, Philadelphia, Pennsylvania 19102, United States; Recruiting
Howard Eisen, MD, Phone: 215-762-3829
Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States; Recruiting
Srinivas Murali, MD, Phone: 412-359-3527
Memorial Hospital of Rhode Island, Pawtucket, Rhode Island 02860, United States; Recruiting
Charles Eaton, MD, Phone: 401-729-2625
The Stern Cardiovascular Center, PA, Germantown, Tennessee 38136, United States; Recruiting
Frank McGrew, MD, Phone: 901-271-1000
VA North Texas Health Care Clinic, Dallas, Texas 75216, United States; Recruiting
Subhash Banerjee, MD, Phone: 214-857-1608
Heart Center, Salt Lake City, Utah 84124, United States; Recruiting
James Zebrack, MD, Phone: 801-266-3418
University of Wisconsin Hospital and Clinics, Madison, Wisconsin 53792, United States; Recruiting
Nancy Sweitzer, MD, PhD, Phone: 608-263-0080
