- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01130597
Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease
A Multicenter, Open-Label, Single-Arm Study to Evaluate a Titration Regimen for Patiromer in Heart Failure Patients With Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was an open-label, single-arm study to evaluate a titration regimen for patiromer in approximately 63 HF participants with CKD receiving one or more of the following: angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), or beta blockers (BBs). This study was considered to be exploratory.
Upon successful completion of screening evaluations (-10 to -5 days prior to enrollment), all eligible participants were assigned at Baseline (Day 0 visit) to an initial dose of patiromer (20 g/day) and spironolactone (25 mg/day).
Study visits for enrolled participants were scheduled for Days 3, 7, 14, 21, 28, 35, 42, 49 and 56. A follow-up visit occurred on Day 63.
At selected study visits, patiromer or spironolactone doses may have been titrated. The study dosing algorithm was designed to maintain an individual's serum potassium value in the range of 4.0 - 5.1 mEq/L (based on local lab data).
Any participant with a local laboratory serum potassium value < 3.5 or > 5.5 mEq/L on two consecutive scheduled study visits, despite titration of patiromer or spironolactone, were withdrawn from the study, permanently discontinued patiromer and spironolactone, and returned for a follow-up visit within 7 days.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Tbilisi, Georgia
- Investigator Site 11
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Tbilisi, Georgia
- Investigator Site 12
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Tbilisi, Georgia
- Investigator Site 13
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Tbilisi, Georgia
- Investigator Site 14
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Tbilisi, Georgia
- Investigator Site 15
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Tbilisi, Georgia
- Investigator Site 16
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Tbilisi, Georgia
- Investigator Site 17
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Tbilisi, Georgia
- Investigator Site 18
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Golnik, Slovenia
- Investigator Site 25
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Izola, Slovenia
- Investigator Site 27
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Ljubljana, Slovenia
- Investigator Site 21
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Maribor, Slovenia
- Investigator Site 22
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Slovenj Gradec, Slovenia
- Investigator Site 26
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronic HF clinically indicated to receive spironolactone therapy
- Age 18 years or older
- Local laboratory serum potassium values of 4.3 - 5.1 mEq/L at screening and baseline
- CKD (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m2 at screening based on central lab creatinine measurement)
- On at least one of the following HF therapies: ACEI, ARB, or BB
- 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
- Provide their written informed consent prior to participation in the study
Exclusion Criteria:
- History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery
- Uncorrected primary severe 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 2 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 or at risk for tumor lysis syndrome
- History of alcoholism or drug/chemical abuse within 1 year
- Sustained systolic blood pressure > 180 or < 90 mmHg
- Liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] > 3 times upper limit of normal
- Loop and thiazide diuretics that have not been stable for at least 21 days prior to baseline or not anticipated to remain stable during study participation
- Use of any intravenous cardiac medications within 21 days prior to baseline, or their anticipated need during study participation
- Current use of polymer-based drugs (e.g., sevelamer, sodium polystyrene sulfonate, colesevelam, colestipol), phosphate binders (e.g., lanthanum carbonate), or other potassium binders, or their anticipated need during study participation
- Use of potassium sparing medication including aldosterone antagonists or potassium supplements in the last 21 days prior to baseline
- Use of any investigational medication within 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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: patiromer
spironolactone + patiromer
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Active investigational drug
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment
Time Frame: 56 days
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56 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 4
Time Frame: 28 Days
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28 Days
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Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 8
Time Frame: 56 Days
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56 Days
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Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 4
Time Frame: 28 Days
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28 Days
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Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 8
Time Frame: 56 Days
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56 Days
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Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at the End of Treatment
Time Frame: 56 Days
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56 Days
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Mean Dose of Patiromer at End of Treatment
Time Frame: 56 Days
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56 Days
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Percentage of Participants Requiring Patiromer Uptitration
Time Frame: 56 Days
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56 Days
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Percentage of Participants Requiring Patiromer Downtitration
Time Frame: 56 Days
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56 Days
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Median Time to First Patiromer Dose Titration
Time Frame: 56 Days
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56 Days
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Mean Number of Patiromer Titrations
Time Frame: 56 Days
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56 Days
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Mean Patiromer Dose at Week 1
Time Frame: Up to Week 1
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Up to Week 1
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Mean Patiromer Dose at Week 4
Time Frame: Up to Week 4
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Up to Week 4
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Mean Patiromer Dose at Week 8
Time Frame: Up to Week 8
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Up to Week 8
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Mean Change From Baseline in Serum Potassium to End of Treatment
Time Frame: 56 Days
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56 Days
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Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L)
Time Frame: 56 Days
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56 Days
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Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day
Time Frame: 56 Days
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56 Days
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Change in Urine Albumin to Creatinine Ratio (ACR) From Baseline to Week 4 Among Participants With ACR ≥ 30 mg/g at Baseline
Time Frame: Baseline and Day 28
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Baseline and Day 28
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Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline
Time Frame: Baseline and Day 56
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Baseline and Day 56
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Urologic Diseases
- Renal Insufficiency
- Heart Failure
- Kidney Diseases
- Renal Insufficiency, Chronic
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Natriuretic Agents
- Diuretics
- Hormone Antagonists
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Spironolactone
Other Study ID Numbers
- RLY5016-204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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