Evaluation of RLY5016 in Heart Failure Patients
Overview[ - collapse ][ - ]
| Purpose | 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. |
|---|---|
| Condition | Hyperkalemia Heart Failure |
| Intervention | Drug: Spironolactone + RLY5016 Drug: Spironolactone + Placebo |
| Phase | Phase 2 |
| Sponsor | Relypsa, Inc. |
| Responsible Party | Relypsa, Inc. |
| ClinicalTrials.gov Identifier | NCT00868439 |
| First Received | March 23, 2009 |
| Last Updated | May 20, 2013 |
| Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 23, 2009 |
|---|---|
| Last Updated Date | May 20, 2013 |
| Start Date | April 2009 |
| Estimated Primary Completion Date | December 2009 |
| Current Primary Outcome Measures | Change from baseline in serum potassium [Time Frame: 28 days] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Safety and tolerability [Time Frame: 28 days] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Evaluation of RLY5016 in Heart Failure Patients |
|---|---|
| Official Title | A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Study to Evaluate the Effects of RLY5016 in Heart Failure Patients |
| Brief Summary | 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. |
| Detailed Description | Double-blind, randomized, placebo-controlled, parallel-group, multiple-dose study in up to 270 congestive heart failure patients. Depending on the outcome from the initial cohort of 100 patients (Part 1), a second cohort of 170 patients may be enrolled (Part 2). Part 1: One hundred eligible patients will be randomly assigned to receive RLY5016 (30 g/day) or placebo for 28 days. All patients will also receive spironolactone; the initial spironolactone dose is 25 mg daily and will be increased to 50 mg daily for patients who have a serum potassium ≤ 5.1 mEq/L on treatment Day 14. Study visits will be scheduled for treatment Days 3, 7, 14, 17, 21 and 28. A safety follow-up contact will be made 7 days after administration of last dose of study drug. An interim analysis will be conducted after data from Part 1 are available. Part 2: One hundred seventy eligible patients will be randomly assigned to one of two RLY5016 treatment groups (15 or 60 g/day) or placebo for 28 days. All patients will also receive spironolactone for 28 days; the initial spironolactone dose is 25 mg daily and will be increased to 50 mg daily for patients who have a serum potassium ≤ 5.1 mEq/L on treatment Day 14. Study visits will be scheduled for treatment Days 3, 7, 14, 17, 21 and 28. A safety follow-up contact will be made 7 days after administration of last dose of study drug. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention |
| Condition |
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| Intervention | Drug: Spironolactone + RLY5016 Active investigational drug Drug: Spironolactone + Placebo Placebo |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 105 |
| Estimated Completion Date | December 2009 |
| Estimated Primary Completion Date | November 2009 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Czech Republic, Georgia, Germany, Poland, Russian Federation, Ukraine |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00868439 |
|---|---|
| Other Study ID Numbers | RLY5016-202 |
| Has Data Monitoring Committee | No |
| Information Provided By | Relypsa, Inc. |
| Study Sponsor | Relypsa, Inc. |
| Collaborators | Medpace, Inc. |
| Investigators | Study Director: Yuri Stasiv, Phd Relypsa, Inc. |
| Verification Date | May 2013 |
Locations[ + expand ][ + ]
| Sutter Transplant Heart Specialty Clinic | Sacramento, California, United States, 95819 |
|---|---|
| University of Florida Health Science Center at Jacksonville | Jacksonville, Florida, United States, 32209 |
| South Florida Research Group LLC | Miami, Florida, United States, 33176 |
| Charlotte Cardiovascular Institute | Port Charlotte, Florida, United States, 33952 |
| Brevard Cardiovascular Research Associates | Rockledge, Florida, United States, 32955 |
| Florida Cardiovascular Institute | Tampa, Florida, United States, 33609 |
| WellStar Cardiovascular Medicine | Marietta, Georgia, United States, 30060 |
| Methodist Medical Group Cardiology | Peoria, Illinois, United States, 61606 |
| Southern Maine Medical Center PrimeCare Physician Services | Biddeford, Maine, United States, 04005 |
| Minneapolis VA Medical Center | Minneapolis, Minnesota, United States, 55417 |
| The Valley Hospital | Ridgewood, New Jersey, United States, 07450 |
| Buffalo Heart Group | Buffalo, New York, United States, 14215 |
| Northport VAMC Medical Services | Northport, New York, United States, 11768 |
| University of Rochester Medical Center | Rochester, New York, United States, 14642 |
| University of Cincinatti | Cincinatti, Ohio, United States, 45267 |
| Lindner Center for Research and Education at the Christ Hospital | Cincinnati, Ohio, United States, 45219 |
| Davis Heart & Lung Research Institute | Columbus, Ohio, United States, 43210 |
| Greater Cincinatti Cardiovascular Consultants, Inc | Fairfield, Ohio, United States, 45014 |
| Hahnemann University Hospital / Tenet | Philadelphia, Pennsylvania, United States, 19102 |
| Allegheny General Hospital | Pittsburgh, Pennsylvania, United States, 15212 |
| Memorial Hospital of Rhode Island | Pawtucket, Rhode Island, United States, 02860 |
| The Stern Cardiovascular Center, PA | Germantown, Tennessee, United States, 38136 |
| VA North Texas Health Care Clinic | Dallas, Texas, United States, 75216 |
| Heart Center | Salt Lake City, Utah, United States, 84124 |
| University of Wisconsin Hospital and Clinics | Madison, Wisconsin, United States, 53792 |
| Faculty Hospital, Internal Cardiology Clinic, | Brno, Czech Republic, 62500 |
| Faculty Hospital Hradec Králové | Hradec Králové, Czech Republic, 500 05 |
| Klinika Kardiologie IKEM | Prague, Czech Republic, 14059 |
| Interni Klinika Kardiologie a Angiologie | Prague, Czech Republic, 12800 |
| Diagnostic Services Clinic LTD | Tblisi, Georgia, 0179 |
| Multiprofile Clinical Hospital of Tblisi #2, LTD | Tblisi, Georgia, 0164 |
| Cardio-Reaninmation Centre LTD | Tblisi, Georgia, 0141 |
| JSC National Center of Therapy | Tblisi, Georgia, 0159 |
| EOPL Tbilisi State Medical University Alexandre Aladashvili University Clinic | Tblisi, Georgia, 0102 |
| Charite - Universitatsmedizen Berlin | Berlin, Germany, D-13353 |
| Kardiologie Klinik J.W Goethe Universitat | Frankfurt, Germany, 60590 |
| University of Goettingen Georg-August-Universitaet Kardiologie und Pneumologie | Goettingen, Germany, 37075 |
| Kardiologische Schwerpunktprxis | Heidelberg, Germany, 69120 |
| Department of Cardiology, Medical Univeristy of Lodz | Lodz, Poland, 91-425 |
| Katedra i Klinika Kardiologii | Lublin, Poland, 20-954 |
| Instytut Kardiologii II, Klinika Choroby Wiencowej | Warsaw, Poland, 02637 |
| Municipal Healthcare Institution - City Hospital #1 | Barnaul, Russian Federation, 656099 |
| Municipal Healthcare Institute Kemerovo Cardiology Dispensary | Kemerovo, Russian Federation, 650002 |
| Federal State Institution Outpatient Clinic #3 | Moscow, Russian Federation, 129090 |
| State Healthcare Institution of Moscow - City Hospital #15 | Moscow, Russian Federation, 111539 |
| Federal State Institution Research Institute of Physical & Chemical Medicine of Roszdraz | Moscow, Russian Federation, 111020 |
| State Healthcare Institution of Moscow City Hospital #40 | Moscow, Russian Federation, 129301 |
| Federal Centre of heart, blood, endocrinology n.a. Almazov | St Petersburg, Russian Federation, 197341 |
| St Petersburg State Healthcare Institution, Pokrovskaya City Hospital | St Petersburg, Russian Federation, 199106 |
| St Petersburg State Healthcare Institution, City Hospital #15 | St Petersburg, Russian Federation, 198205 |
| State Institution Scientific Research Institute of Cardiology Tomsk | Tomsk, Russian Federation, 634012 |
| Dnipropetrovsk City Clinical Hospital No. 9 Cardiology Department | Dnipropetrovsk, Ukraine, 49023 |
| City Clinical Emergency Hospital, Therapy Department | Kharkiv, Ukraine, 61018 |
| Malaya Institute of Therapy, AMS of Ukraine | Kharkiv, Ukraine, 61039 |
| Kharkiv City Clinical Hospital No. 8, Department of Cardiology and Functional Diagnostics | Kharkiv, Ukraine, 61176 |
| Institute of Gerontology, AMS of Ukraine | Kiev, Ukraine, 04114 |
| National Medical University O.O. Bogomolets | Kiev, Ukraine, 01601 |
| National Scientific Center - Strazhesko Institute of Cardiology | Kiev, Ukraine, 03680 |