| Trial ID: | L1450 |
| Source ID: | NCT01130597
|
| Associated Drug: |
Patiromer
|
| Title: |
Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01130597/results
|
| Conditions: |
Heart Failure
|
| Interventions: |
DRUG: patiromer|DRUG: spironolactone
|
| Outcome Measures: |
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|Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 8, 56 Days|Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 4, 28 Days|Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 8, 56 Days|Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at the End of Treatment, 56 Days|Mean Dose of Patiromer at End of Treatment, 56 Days|Percentage of Participants Requiring Patiromer Uptitration, 56 Days|Percentage of Participants Requiring Patiromer Downtitration, 56 Days|Median Time to First Patiromer Dose Titration, 56 Days|Mean Number of Patiromer Titrations, 56 Days|Mean Patiromer Dose at Week 1, Up to Week 1|Mean Patiromer Dose at Week 4, Up to Week 4|Mean Patiromer Dose at Week 8, Up to Week 8|Mean Change From Baseline in Serum Potassium to End of Treatment, 56 Days|Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L), 56 Days|Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day, 56 Days|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|Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline, Baseline and Day 56
|
| Sponsor/Collaborators: |
Sponsor: Relypsa, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
63
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2010-05
|
| Completion Date: |
2010-09
|
| Results First Posted: |
2016-01-28
|
| Last Update Posted: |
2021-05-12
|
| Locations: |
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, Georgia|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, Slovenia
|
| URL: |
https://clinicaltrials.gov/show/NCT01130597
|
