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Spironolactone in CKD Enabled by Chlorthalidone: PILOT — SPICE PILOT  

Renal Insufficiency Clinical Trial

Official title:
Spironolactone in Chronic Kidney Disease Enabled by Chlorthalidone: A Pilot Randomized Control Trial

Clinical Trial 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.

Clinical Trial Description

This is a placebo-controlled, double-blind, randomized controlled trial of spironolactone (SPL) and chlorthalidone (CTD) in patients with CKD and poorly controlled hypertension ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05222191
Study type Interventional
Source Indiana Institute for Medical Research
Contact Rajiv Agarwal, MD
Phone 317-988-2241
Email ragarwal@iu.edu
Status Recruiting
Phase Phase 2
Start date February 1, 2022
Completion date December 12, 2023
View Details
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