Spironolactone in CKD Enabled by Chlorthalidone: PILOT

Last updated: August 11, 2023
Sponsor: Indiana Institute for Medical Research
Overall Status: Active - Recruiting

Phase

2

Condition

Circulation Disorders

Stress

Nephropathy

Treatment

Spironolactone

Chlorthalidone

Placebo

Clinical Study ID

NCT05222191
12672
  • Ages 19-110
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age greater than 18 years.
  2. GFR estimated by CKD-EPI formula < 45 ml/min/1.73 m2 but ≥ 15 mL/min/1.73 m2 usingIDMS-calibrated creatinine.
  3. Hypertension. Using AOBP monitoring, BP of ≥ 130/80 mmHg.
  4. Treatment with antihypertensive drugs: This would require the use of at least oneantihypertensive drug. One of the drugs should be either an ACE inhibitor or ARB or abeta-blocker at the time of randomization.
  5. Serum K 3.5 to 5.2 mEq/L at the time of randomization. In patients with eGFR < 45ml/min/1.73 m2 and serum K > 5.2 mEq/L

Exclusion

Exclusion Criteria:

  1. Use of spironolactone, eplerenone, amiloride, triamterene, thiazides, or thiazide-likedrugs or the use of K supplements or K binders in the previous 12 weeks.
  2. Expected to receive renal replacement therapy within the next 6 months.
  3. Myocardial infarction, heart failure hospitalization, or stroke ≤ 12 weeks prior torandomization.
  4. Pregnant or breastfeeding women or women who are planning to become pregnant or thosenot using a reliable form of contraception (oral contraceptives. condoms anddiaphragms will be considered reliable).
  5. Known hypersensitivity to thiazide or spironolactone.
  6. Clinic AOBP <110 mmHg systolic at their first visit

Study Design

Total Participants: 24
Treatment Group(s): 3
Primary Treatment: Spironolactone
Phase: 2
Study Start date:
February 01, 2022
Estimated Completion Date:
December 12, 2023

Study 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

Connect with a study center

  • Richard L Roudebush VA Medical Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

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