CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 324 enrolled
Drug / intervention
patiromer +7 moredrug
Likely dose
patiromer 8.4 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01371747
NCT01371747Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Open-Label, Dose Ranging Study to Evaluate the Efficacy and Safety of Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy Receiving Angiotensin-converting Enzyme Inhibitor (ACEI) and/or Angiotensin II Receptor Blocker (ARB) Drugs, With or Without Spironolactone

Relypsa, Inc.·interventional·Posted Jun 13, 2011·Updated Jun 3, 2021

In Brief

A Phase 2 clinical trial evaluating patiromer, losartan, and 1 other intervention for Chronic Kidney Disease and 2 related conditions. Completed, enrolled 324 participants across 43 sites in 5 countries.

Detailed Summary

This study determined the optimal starting dose of patiromer in treating hyperkalemia in participants with hypertension and diabetic nephropathy who were already receiving ACEI and/or ARB drugs, with or without spironolactone. This study also evaluated the efficacy and safety of patiromer and the long term use of patiromer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Hypertension, Hyperkalemia
CountriesCroatia, Georgia, Hungary, Serbia, Slovenia
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 13, 2011
Enrollment StartJun 1, 2011
Primary CompletionMay 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 15.1 years ago

Interventions

patiromerdrug

Cohorts 1, 2 and 3 - Patiromer starting dose: 8.4 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response (Stratum 1)

patiromerdrug

Cohorts 1, 2 and 3 - Patiromer starting dose: 16.8 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response. (Stratum 2)

patiromerdrug

Cohorts 1, 2 and 3 - Patiromer starting dose: 16.8 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response (Stratum 1)

patiromerdrug

Cohorts 1, 2 and 3 - Patiromer starting dose: 25.2 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response (Stratum 1)

patiromerdrug

Cohorts 1, 2 and 3 - Patiromer starting dose: 25.2 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response. (Stratum 2)

patiromerdrug

Cohorts 1, 2 and 3 - Patiromer starting dose: 33.6 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response. (Stratum 2)

losartandrug

losartan dose: 100 mg/d, oral, once daily (initiated during Run-In Period; Cohort 1)

spironolactonedrug

Spironolactone dose: 25 mg/d or up to 50 mg/d, oral, once daily (initiated during Run-In Period; Cohort 2)