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).
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 5.5 mEq/L on two consecutive scheduled study visits, despite titration of patiromer or spironolactone, were withdrawn from the study, permanently discontinued patiromer and spironolactone, and returned for a follow-up visit within 7 days.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
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
63
Active investigational drug
Investigator Site 11
Tbilisi, Georgia
Investigator Site 12
Tbilisi, Georgia
Investigator Site 13
Tbilisi, Georgia
Investigator Site 14
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
Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 4
Time frame: 28 Days
Percentage of Participants With Serum Potassium in the Range of 3.5 - 5.5 mEq/L at Week 8
Time frame: 56 Days
Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 4
Time frame: 28 Days
Percentage of Participants With Serum Potassium in the Range of 4.0 - 5.1 mEq/L at Week 8
Time frame: 56 Days
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
Mean Dose of Patiromer at End of Treatment
Time frame: 56 Days
Percentage of Participants Requiring Patiromer Uptitration
Time frame: 56 Days
Percentage of Participants Requiring Patiromer Downtitration
Time frame: 56 Days
Median Time to First Patiromer Dose Titration
Time frame: 56 Days
Mean Number of Patiromer Titrations
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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
...and 3 more locations
Time frame: 56 Days
Mean Patiromer Dose at Week 1
Time frame: Up to Week 1
Mean Patiromer Dose at Week 4
Time frame: Up to Week 4
Mean Patiromer Dose at Week 8
Time frame: Up to Week 8
Mean Change From Baseline in Serum Potassium to End of Treatment
Time frame: 56 Days
Percentage of Participants Discontinuing Due to Hyperkalemia (Serum Potassium > 5.5 mEq/L)
Time frame: 56 Days
Percentage of Patients Whose Spironolactone Dose Was Increased Up to 50 mg/Day
Time frame: 56 Days
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
Change in ACR From Baseline to Week 8 Among Participants With Urine ACR ≥ 30 mg/g at Baseline
Time frame: Baseline and Day 56