LOw DosE Spironolactone, chlorThAlidone oR Combination in CKD Trial (NCT07645300) | Clinical Trial Compass
Not Yet RecruitingPhase 2
LOw DosE Spironolactone, chlorThAlidone oR Combination in CKD Trial
United States160 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Unattended systolic automated office blood pressure in phase 2A
Timeframe: 12 weeks
2
Serum K phase 2A
Timeframe: 12 weeks
3
Unattended systolic automated office blood pressure in phase 2B