MedTrace Logo

LOw DosE Spironolactone, chlorThAlidone oR Combination in CKD Trial

NCT07645300 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-06-12

No results posted yet for this study

Summary

The purpose of this research is to gather information on the safety and effectiveness of spironolactone and chlorthalidone for treatment of high blood pressure in patients with moderate to advanced CKD. Both drugs have been approved by the Food and Drug Administration (FDA) for the treatment of high blood pressure since 1960.

Conditions

  • Hypertension Treated With Antihypertensive Drugs
  • Chronic Kidney Disease, 3B and 4

Interventions

DRUG

phase 2A Chlorthalidone

very low dose (VLD) x 6 weeks then low dose (LD) x 6 weeks

DRUG

phase 2A Spironolactone

very low dose (VLD) x 6 weeks then low dose (LD) x 6 weeks

DRUG

phase 2A Chlorthalidone + Spironolactone

very low dose (VLD) x 6 weeks then low dose (LD) x 6 weeks

DRUG

phase 2B Chlorthalidone LD + Spironolactone LD

compare combination LD with SPL LD at 12 weeks

Sponsors & Collaborators

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • VA Salt Lake City Health Care System

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Rajiv Agarwal, MD MBBS · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2032-03-31
Completion
2032-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT07645300 on ClinicalTrials.gov