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NCT07645300

LOw DosE Spironolactone, chlorThAlidone oR Combination in CKD Trial

Not Yet Recruiting
PHASE2Ages 18–90InterventionalTreatment
VA Office of Research and Development
~160 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:phase 2A Chlorthalidonephase 2A Spironolactonephase 2A Chlorthalidone + Spironolactonephase 2B Chlorthalidone LD + Spironolactone LD

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Unattended systolic automated office blood pressure in phase 2A
Measured over 12 weeks
+2 more outcomes measured

Conditions

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

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Chronic Kidney DiseaseHypertension

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • Rajiv Agarwal, MD MBBS · PRINCIPAL_INVESTIGATOR · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Who to contact

Rajiv Agarwal, MD MBBS
[email protected]
(317) 988-2241
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Unattended systolic automated office blood pressure in phase 2A12 weeks

    phase 2A: the primary endpoint will be assessed by change from baseline to 6 weeks and 12 weeks in systolic AOBP for the combination group compared to placebo.

  • Serum K phase 2A12 weeks

    phase 2A: the primary endpoint will be assessed by change from baseline to 12 weeks in serum K for the combination group compared to placebo.

  • Unattended systolic automated office blood pressure in phase 2B12 weeks

    phase 2B: the primary endpoint will be assessed by change from baseline to 12 weeks in systolic AOBP for the combination LD group compared to SPL.