drugset / Trial / NCT03502031

Safety and Efficacy of Two Year of RAAS Alone or in Combination With Spironolactone Therapy

NCT03502031

Phase 4 Unknown 72 enrolled James A. Tumlin, MD Nelson Kopyt, MD · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

NephroNet proposes to examine whether combining Spironolactone with maximal RAAS blockade will further reduce urinary protein at one year and whether prolonged therapy (24 months) is able to slow the decline in GFR. Because of combination MRA and RAAS therapy significantly increases the risk for clinically significant hyperkalemia, we also plan to determine whether the addition of Patiromer to these patients facilitates the use of combination therapy and allows a larger proportion of diabetic patients the potential benefit of combination therapy on renal function.

Timeline

Start
2018-10-01
Primary completion
2022-10-01
Completion
2024-10-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Spironolactone Small molecule 25 mg
Comparator Enalapril Other / unclassified
Comparator LISINOPRIL ANHYDROUS Small molecule
Comparator Losartan Other / unclassified
Comparator Perindopril Small molecule
Comparator Valsartan Small molecule