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

NCT03502031 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-10-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Nelson Kopyt, MD

    collaborator UNKNOWN

  • James A. Tumlin, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2022-10-01
Completion
2024-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03502031 on ClinicalTrials.gov