drugset / Trial / NCT05222191

Spironolactone in CKD Enabled by Chlorthalidone: PILOT

NCT05222191

Phase 2 Unknown 24 enrolled Indiana Institute for Medical Research
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Highly prevalent among patients with chronic kidney disease (CKD) and poorly controlled blood pressure (BP), is a modifiable risk factor to abrogate both kidney failure progression and cardiovascular (CV) disease. Spironolactone (SPL), a mineralocorticoid receptor antagonist, is widely used to treat resistant hypertension, however one of the most common side effects is an increase of serum potassium (K). This side effect occurs frequently in those who suffer from CKD. Alternatively, chlorthalidone (CTD) is a thiazide-like diuretic used for treating hypertension and decreases serum K. In this pilot study, our goal is to assess whether the combination of SPL and CTD can improve BP control, while also reducing the risk of hyperkalemia over a period of 12 weeks. We hypothesize that among patients with CKD and poorly controlled hypertension, compared to SPL and placebo, treatment over 12 weeks with CTD will counter the hyperkalemia effect of SPL, and therefore the combination of SPL with CTD will result in a lower BP. This pilot study will be performed at Richard L. Roudebush VA in Indianapolis, Indiana.

Timeline

Start
2022-02-01
Primary completion
2023-12-12
Completion
2023-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorthalidone Other / unclassified 6.25 mg
Subject Spironolactone Small molecule 25 mg