drugset / Trial / NCT01371747

Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)

NCT01371747

Phase 2 Completed 324 enrolled Relypsa, Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-06
Primary completion
2013-05
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Patiromer Other / unclassified 8.4 g Oral
Subject Patiromer Other / unclassified 16.8 g Oral
Subject Patiromer Other / unclassified 25.2 g Oral
Subject Patiromer Other / unclassified 33.6 g Oral
Background Losartan Other / unclassified 100 mg Oral
Background Spironolactone Small molecule 25 mg Oral
Background Spironolactone Small molecule 50 mg Oral