LOw DosE Spironolactone, chlorThAlidone oR Combination in CKD Trial

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
VA Office of Research and Development
Study ID
NCT07645300
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • phase 2A Chlorthalidone — DRUG
    very low dose (VLD) x 6 weeks then low dose (LD) x 6 weeks
  • phase 2A Spironolactone — DRUG
    very low dose (VLD) x 6 weeks then low dose (LD) x 6 weeks
  • phase 2A Chlorthalidone + Spironolactone — DRUG
    very low dose (VLD) x 6 weeks then low dose (LD) x 6 weeks
  • phase 2B Chlorthalidone LD + Spironolactone LD — DRUG
    compare combination LD with SPL LD at 12 weeks

Study Details

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.

Key Dates

Start date
Oct 1, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2032
Completion
Jun 30, 2032

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: placebo
    phase 2A
  • Experimental: Chlorthalidone
    phase 2A Chlorthalidone(CTD) very low dose (VLD) x 6 weeks
  • Experimental: Spironolactone
    phase 2A Spironolactone(SPL) very low dose (VLD) x 6 weeks
  • Experimental: CTD + SPL
    phase 2A Chlorthalidone(CTD) VLD + Spironolactone(SPL) VLD x 6 weeks
  • Active Comparator: 2B CTD
    phase 2B Chlorthalidone(CTD) low dose (LD) x 12 weeks
  • Active Comparator: 2B SPL
    phase 2B Spironolactone(SPL) low dose (LD) x 12 weeks
  • Experimental: 2B VLD CTD + VLD SPL
    phase 2B Chlorthalidone(CTD) VLD + Spironolactone(SPL) VLD x 12 weeks
  • Experimental: 2B LD CTD + LD SPL
    phase 2B Chlorthalidone(CTD) LD + Spironolactone(SPL) LD x 12 weeks

Primary Outcome Measure

Unattended systolic automated office blood pressure in phase 2A [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolisIndiana46202-2884
Rajiv Agarwal, MD MBBS
[email protected]
317-988-2241
Rajiv Agarwal, MD MBBS (PRINCIPAL_INVESTIGATOR)

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By research site
Richard L. Roudebush VA Medical Center, Indianapolis, IN· Indianapolis, IN