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Not yet recruitingPhase 2

LOw DosE Spironolactone, chlorThAlidone oR Combination in CKD Trial

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 weeks, 12 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "After a two-week, patient-blind, placebo run-in, the investigators will randomize 50 hypertensive people to one of 4 groups in equal numbers: placebo; CTD very low dose; SPL very low dose QD; or a combination of CTD very low dose + SPL very low dose for 6 weeks."
  • "In this trial, the investigators will test the hypothesis that among patients with moderate to advanced CKD and poorly controlled hypertension, compared to add-on SPL or add-on CTD, treatment over 12 weeks with add-on combination of spironolactone (SPL) and chlorthalidone (CTD) will more effectively lower unattended systolic automated office blood pressure (uAOBP)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and effective spironolactone and chlorthalidone are for treating high blood pressure. It is for U.S. Veterans with moderate to advanced chronic kidney disease (CKD).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Must be a U.S. Veteran.
  • Have a kidney filtering rate (GFR) below 45. The listing also gives a lower value of 15, but the exact lower cutoff is unclear.
  • Have an automatic blood pressure reading in the clinic of at least 135/85.
  • Take at least one blood pressure medicine. When assigned to a study group, one medicine must be an ACE inhibitor, ARB, or beta-blocker.
  • Have a blood potassium level of 3.5 to 5.2 mEq/L when assigned to a study group.

Who can't join

  • Have an automatic blood pressure reading in the clinic of 160/100 or higher.
  • Used spironolactone, eplerenone, amiloride, triamterene, or finerenone in the past 4 weeks.
  • Used thiazide or thiazide-like water pills in the past 4 weeks, including chlorthalidone, hydrochlorothiazide, metolazone, or indapamide.
  • Used potassium binders (medicines that lower potassium) or fludrocortisone in the past 4 weeks. Potassium supplements are allowed.
  • Had a heart attack, a hospital stay for heart failure, or a stroke in the 8 weeks before assignment to a study group.
  • Take only an alpha-blocker for blood pressure, with no other blood pressure medicine.
  • Are pregnant, breastfeeding, planning pregnancy, or a woman not using reliable birth control.
  • Have a known allergy or a past recorded bad reaction to chlorthalidone or spironolactone.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Clinic AOBP of \>=160/100 mmHg * 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 * Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception * Known hypersensitivity or a prior documented adverse reaction to CTD or SPL

Study sites (1)

IN