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NCT07645300Not yet recruitingPhase 2

LOw DosE Spironolactone, chlorThAlidone oR Combination in CKD Trial

LOw DosE Spironolactone, chlorThAlidone oR Combination in CKD (LODESTAR) Trial

Source: ClinicalTrials.gov · Last updated 12 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
160 (estimated)
First submitted
8 Jun 2026
Start date
1 Oct 2026
Primary completion date
31 Mar 2032
Lead sponsor
VA Office of Research and Development
NCT number
NCT07645300

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 160
  • From 1 Oct 2026 to the primary completion date, 31 Mar 2032
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of:
    • SPL
    • eplerenone
    • amiloride
    • triamterene
    • finerenone
    • thiazide
    • thiazide-like drugs (CTD, HCTZ, metolazone, indapamide) or the use of K binders or fludrocortisone in the previous 4 weeks
    • K supplementation would be allowed
  • Myocardial infarction, heart failure hospitalization, or stroke 8 weeks prior to randomization
  • If the patient is only on an alpha blocker, as the sole antihypertensive drug, they will be excluded
  • Known hypersensitivity or a prior documented adverse reaction to CTD or SPL

Other

  • Clinic AOBP of \>=160/100 mmHg
  • Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception

Who the study is looking for

  • Study is limited to US Veterans
  • GFR estimated by race-independent CKD-EPI formula \< 45 ml/min/1.73m2 but 15 mL/min/1.73m2
  • Hypertension
    • The investigators will use clinic AOBP of at least 135/85 to define hypertension
  • Treatment with antihypertensive drugs
    • This would require the use of at least one antihypertensive drug
    • One of the drugs should be either an ACE inhibitor or ARB or a beta-blocker at the time of randomization
  • Serum K 3.5 to 5.2 mEq/L at the time of randomization

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Coordinator of this site? Confirm its status		IndianapolisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.