Evaluation of Patiromer in Heart Failure Patients
- Registration Number
- NCT00868439
- Lead Sponsor
- Relypsa, Inc.
- Brief Summary
The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.
- Detailed Description
This was a double-blind, randomized, placebo-controlled, parallel-group, multiple-dose study in congestive heart failure participants. Depending on the outcome from the initial cohort of 100 participants (Part 1), a second cohort of 170 participants could have been enrolled (Part 2). Based on the results of Part 1 of the study, Part 2 was not conducted.
Participants were randomly assigned to and received patiromer (30 g/day) or placebo for up to 28 days. All participants also received spironolactone; the initial spironolactone dose was 25 mg daily and was increased to 50 mg daily for participants who had a serum potassium ≤ 5.1 mEq/L on treatment Day 14. Study visits occurred on treatment Days 3, 7, 14, 17, 21 and 28. A safety follow-up contact was made 7 days after administration of last dose of study drug.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Participants with chronic heart failure clinically indicated to receive spironolactone therapy, aged 18 years or older with serum potassium level of 4.3 - 5.1 mEq/L at screening and baseline, AND (1) chronic kidney disease (GFR < 60 mL/min) OR (2) 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 participants 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
- 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 participant, 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
- Participants who have taken investigational product in this study, or a previous patiromer 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 participant or affect the validity of the trial results
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description patiromer patiromer - placebo placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period. Baseline and Day 28
- Secondary Outcome Measures
Name Time Method Time to First Elevated Serum K+ > 5.5 mEq/L. 28 Days Proportion of Participants Whose Spironolactone Dose Was Increased. 28 Days Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L). 28 Days Analysis based on local laboratory data.
Proportion of Participants With an Increase in Serum Potassium Level From Baseline to the End of the 28-day Treatment Period That Was ≥ 0.5 mEq/L Baseline and Day 28 Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L. 28 Days Analysis based on central laboratory data.
Trial Locations
- Locations (33)
Investigator Site 031
🇺🇸Port Charlotte, Florida, United States
Investigator Site 009
🇺🇸Peoria, Illinois, United States
Investigator Site 018
🇺🇸Minneapolis, Minnesota, United States
Investigator Site 005
🇺🇸Northport, New York, United States
Investigator Site 102
🇨🇿Brno, Czechia
Investigator Site 104
🇨🇿Prague, Czechia
Investigator Site 103
🇨🇿Prague, Czechia
Investigator Site 605
🇬🇪Tbilisi, Georgia
Investigator Site 603
🇬🇪Tbilisi, Georgia
Investigator Site 201
🇩🇪Gottingen, Germany
Investigator Site 202
🇩🇪Heidelberg, Germany
Investigator Site 409
🇷🇺Barnaul, Russian Federation
Investigator Site 402
🇷🇺Moscow, Russian Federation
Investigator Site 412
🇷🇺St Petersburg, Russian Federation
Investigator Site 405
🇷🇺St Petersburg, Russian Federation
Investigator Site 507
🇺🇦Dnipropetrovsk, Ukraine
Investigator Site 502
🇺🇦Kharkiv, Ukraine
Investigator Site 504
🇺🇦Kiev, Ukraine
Investigator Site 506
🇺🇦Kiev, Ukraine
Investigator Site 501
🇺🇦Kiev, Ukraine
Investigator Site 020
🇺🇸Buffalo, New York, United States
Investigator Site 022
🇺🇸Columbus, Ohio, United States
Investigator Site 001
🇺🇸Dallas, Texas, United States
Investigator Site 019
🇺🇸Salt Lake City, Utah, United States
Investigator Site 604
🇬🇪Tbilisi, Georgia
Investigator Site 407
🇷🇺Kemerovo, Russian Federation
Investigator Site 602
🇬🇪Tbilisi, Georgia
Investigator Site 029
🇺🇸Miami, Florida, United States
Investigator Site 305
🇵🇱Warsaw, Poland
Investigator Site 406
🇷🇺Moscow, Russian Federation
Investigator Site 403
🇷🇺Moscow, Russian Federation
Investigator Site 404
🇷🇺St Petersburg, Russian Federation
Investigator Site 509
🇺🇦Kharkiv, Ukraine