RECRUITING

Spironolactone in CKD Enabled by Chlorthalidone: PILOT

Conditions

Renal Insufficiency Chronic Hypertension Spironolactone Chlorthalidone Chronic Kidney Disease Hypertension Thiazide Diuretic Potassium Sparring Diuretic

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-02-01

Study Completion:2023-12-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05222191

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 110 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 using IDMS-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 one antihypertensive drug. One of the drugs should be either an ACE inhibitor or ARB or a beta-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 \< 45 ml/min/1.73 m2 and serum K \> 5.2 mEq/L	1. Use of spironolactone, eplerenone, amiloride, triamterene, thiazides, or thiazide-like drugs 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 to randomization. 4. Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable). 5. Known hypersensitivity to thiazide or spironolactone. 6. Clinic AOBP \<110 mmHg systolic at their first visit

Inclusion Criteria

Exclusion 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 using IDMS-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 one antihypertensive drug. One of the drugs should be either an ACE inhibitor or ARB or a beta-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 \< 45 ml/min/1.73 m2 and serum K \> 5.2 mEq/L

1. Use of spironolactone, eplerenone, amiloride, triamterene, thiazides, or thiazide-like drugs 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 to randomization.
4. Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable).
5. Known hypersensitivity to thiazide or spironolactone.
6. Clinic AOBP \<110 mmHg systolic at their first visit

Contacts and Locations

Study Contact

Rajiv Agarwal, MD

CONTACT

317-988-2241

ragarwal@iu.edu

Timothy l Ramsey, MS/MBA

CONTACT

317-988-9544

timothy.ramsey2@va.gov

Principal Investigator

Rajiv Agarwal, MD

PRINCIPAL_INVESTIGATOR

Indiana Institute for Medical Research; Roudebush VA Medical Center

Study Locations (Sites)

Richard L Roudebush VA Medical Center

Indianapolis, Indiana, 46202

United States

Collaborators and Investigators

Sponsor: Indiana Institute for Medical Research

Rajiv Agarwal, MD, PRINCIPAL_INVESTIGATOR, Indiana Institute for Medical Research; Roudebush VA Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01

Study Completion Date2023-12-12

Study Record Updates

Study Start Date2022-02-01

Study Completion Date2023-12-12

Terms related to this study

Keywords Provided by Researchers

Spironolactone
Chlorthalidone
Chronic Kidney Disease
Hypertension
Thiazide Diuretic
Potassium Sparring Diuretic

Additional Relevant MeSH Terms

Renal Insufficiency
Chronic Hypertension