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Not listed Phase 4 Interventional

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

ClinicalTrials.gov ID: NCT03502031

Public ClinicalTrials.gov record NCT03502031. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:39 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03502031
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 4
Lead sponsor
James A. Tumlin, MD
Other
Enrollment
72 participants

Conditions and interventions

Eligibility (public fields only)

Age range
75 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2018
Primary completion
Sep 30, 2022
Completion
Sep 30, 2024
Last update posted
Oct 27, 2022

2018 – 2024

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Georgia Nephrology Research Institute Lawrenceville Georgia 30046 Recruiting
Nelson Kopyt, MD Bethlehem Pennsylvania 18017 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03502031, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 27, 2022 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03502031 live on ClinicalTrials.gov.

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