NCT03502031

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

Safety and Efficacy of Maximally Tolerated RAAS Blockade and Spironolactone Therapy on Urinary Proteinuria and Progression of Type II Diabetic Nephropathy in African Americans and Other Patient Cohorts.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: James A. Tumlin, MD · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Insufficiency, Chronic
• Diabetic Nephropathy Type 2

Interventions

Type	Name	Description
DRUG	Renin-Angiotensin (RAAS) alone	maximal RAAS blockade alone for 24months.
DRUG	Renin-Angiotensin (RAAS) blockers in combination with Spironolactone	maximal RAAS blockade alone or in combination with Spironolactone (25 mg) for 24 months.

Timeline

• Start date: 2018-10-01
• Primary completion: 2022-10-01
• Completion: 2024-10-01
• First posted: 2018-04-18
• Last updated: 2022-10-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study