Spironolactone + Chlorthalidone for High Blood Pressure
(LODESTAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Rajiv Agarwal, MD MBBS
Principal Investigator
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Are You a Good Fit for This Trial?
This trial is for adults with moderate to advanced chronic kidney disease (CKD) who also have high blood pressure. People with other serious health issues or conditions that could interfere with the study may not be able to join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Placebo Run-in
Participants undergo a patient-blind, placebo run-in period
Treatment Phase 2A
Participants are randomized to receive placebo, CTD very low dose, SPL very low dose, or a combination of CTD and SPL for 6 weeks
Dose Escalation Phase 2A
Doses are doubled for a further 6 weeks to assess the primary endpoint
Treatment Phase 2B
Participants receive CTD low dose, SPL low dose, or a combination of CTD and SPL for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study is testing how safe and effective low doses of spironolactone, chlorthalidone, or a combination of both are at lowering blood pressure in people with CKD. Participants are assigned different treatments to compare results.
How Is the Trial Designed?
8
Treatment groups
Experimental Treatment
Active Control
Placebo Group
phase 2A Spironolactone(SPL) very low dose (VLD) x 6 weeks
phase 2A Chlorthalidone(CTD) very low dose (VLD) x 6 weeks
phase 2A Chlorthalidone(CTD) VLD + Spironolactone(SPL) VLD x 6 weeks
phase 2B Chlorthalidone(CTD) VLD + Spironolactone(SPL) VLD x 12 weeks
phase 2B Chlorthalidone(CTD) LD + Spironolactone(SPL) LD x 12 weeks
phase 2B Chlorthalidone(CTD) low dose (LD) x 12 weeks
phase 2B Spironolactone(SPL) low dose (LD) x 12 weeks
phase 2A
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Michael E. DeBakey VA Medical Center
Collaborator
VA Salt Lake City Health Care System
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.