Heart Failure Clinical Trial
Official title:
A Multicenter, Open-Label, Single-Arm Study to Evaluate a Titration Regimen for Patiromer in Heart Failure Patients With Chronic Kidney Disease
NCT number | NCT01130597 |
Other study ID # | RLY5016-204 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 2010 |
Est. completion date | September 2010 |
Verified date | December 2015 |
Source | Vifor Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study was to evaluate the feasibility of individualized titration of patiromer according to serum potassium. This study also assessed the safety and tolerability of patiromer and the effects of patiromer on serum potassium in heart failure (HF) participants with chronic kidney disease (CKD).
Status | Completed |
Enrollment | 63 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Chronic HF clinically indicated to receive spironolactone therapy 2. Age 18 years or older 3. Local laboratory serum potassium values of 4.3 - 5.1 mEq/L at screening and baseline 4. CKD (estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m2 at screening based on central lab creatinine measurement) 5. On at least one of the following HF therapies: ACEI, ARB, or BB 6. 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 7. 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 8. Provide their written informed consent prior to participation in the study Exclusion Criteria: 1. History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery 2. Uncorrected primary severe valvular disease, known obstructive or restrictive cardiomyopathy, uncontrolled or hemodynamically unstable arrhythmia 3. 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 4. Heart transplant recipient, or anticipated need for transplant during study participation 5. 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 6. Current dialysis participant, or anticipated need for dialysis during study participation 7. Prior kidney transplant, or anticipated need for transplant during study participation 8. Metastatic, late-stage or end-stage cancer with < 12 months life expectancy or at risk for tumor lysis syndrome 9. History of alcoholism or drug/chemical abuse within 1 year 10. Sustained systolic blood pressure > 180 or < 90 mmHg 11. Liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST)] > 3 times upper limit of normal 12. 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 13. Use of any intravenous cardiac medications within 21 days prior to baseline, or their anticipated need during study participation 14. 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 15. Use of potassium sparing medication including aldosterone antagonists or potassium supplements in the last 21 days prior to baseline 16. Use of any investigational medication within 30 days or 5 half-lives, whichever is longer, prior to baseline 17. Participants who have taken investigational product in this study, or a previous patiromer study 18. Inability to consume the study medication, or, in the opinion of the Investigator, inability to comply with the protocol 19. 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 |
Country | Name | City | State |
---|---|---|---|
Georgia | Investigator Site 11 | Tbilisi | |
Georgia | Investigator Site 12 | Tbilisi | |
Georgia | Investigator Site 13 | Tbilisi | |
Georgia | Investigator Site 14 | Tbilisi | |
Georgia | Investigator Site 15 | Tbilisi | |
Georgia | Investigator Site 16 | Tbilisi | |
Georgia | Investigator Site 17 | Tbilisi | |
Georgia | Investigator Site 18 | Tbilisi | |
Slovenia | Investigator Site 25 | Golnik | |
Slovenia | Investigator Site 27 | Izola | |
Slovenia | Investigator Site 21 | Ljubljana | |
Slovenia | Investigator Site 22 | Maribor | |
Slovenia | Investigator Site 26 | Slovenj Gradec |
Lead Sponsor | Collaborator |
---|---|
Relypsa, Inc. |
Georgia, Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at the End of Treatment | 56 days | ||
Secondary | Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 4 | 28 Days | ||
Secondary | Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 8 | 56 Days | ||
Secondary | Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 4 | 28 Days | ||
Secondary | Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 8 | 56 Days | ||
Secondary | Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at the End of Treatment | 56 Days | ||
Secondary | Mean Dose of Patiromer at End of Treatment | 56 Days | ||
Secondary | Percentage of Participants Requiring Patiromer Uptitration | 56 Days | ||
Secondary | Percentage of Participants Requiring Patiromer Downtitration | 56 Days | ||
Secondary | Median Time to First Patiromer Dose Titration | 56 Days | ||
Secondary | Mean Number of Patiromer Titrations | 56 Days | ||
Secondary | Mean Patiromer Dose at Week 1 | Up to Week 1 | ||
Secondary | Mean Patiromer Dose at Week 4 | Up to Week 4 | ||
Secondary | Mean Patiromer Dose at Week 8 | Up to Week 8 | ||
Secondary | Mean Change From Baseline in Serum Potassium to End of Treatment | 56 Days | ||
Secondary | Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L) | 56 Days | ||
Secondary | Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day | 56 Days | ||
Secondary | Change in Urine Albumin to Creatinine Ratio (ACR) From Baseline to Week 4 Among Participants With ACR = 30 mg/g at Baseline | Baseline and Day 28 | ||
Secondary | Change in ACR From Baseline to Week 8 Among Participants With Urine ACR = 30 mg/g at Baseline | Baseline and Day 56 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Active, not recruiting |
NCT05896904 -
Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction
|
N/A | |
Completed |
NCT05077293 -
Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
|
||
Recruiting |
NCT05631275 -
The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
|
||
Enrolling by invitation |
NCT05564572 -
Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology
|
N/A | |
Enrolling by invitation |
NCT05009706 -
Self-care in Older Frail Persons With Heart Failure Intervention
|
N/A | |
Recruiting |
NCT04177199 -
What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
|
||
Terminated |
NCT03615469 -
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
|
N/A | |
Recruiting |
NCT06340048 -
Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure
|
Phase 1/Phase 2 | |
Recruiting |
NCT05679713 -
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
|
||
Completed |
NCT04254328 -
The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure
|
N/A | |
Completed |
NCT03549169 -
Decision Making for the Management the Symptoms in Adults of Heart Failure
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Enrolling by invitation |
NCT05538611 -
Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
|
||
Recruiting |
NCT04262830 -
Cancer Therapy Effects on the Heart
|
||
Completed |
NCT06026683 -
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
|
N/A | |
Withdrawn |
NCT03091998 -
Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support
|
Phase 1 | |
Recruiting |
NCT05564689 -
Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy
|