Status:
UNKNOWN
Spironolactone in CKD Enabled by Chlorthalidone: PILOT
Lead Sponsor:
Indiana Institute for Medical Research
Conditions:
Renal Insufficiency
Chronic Hypertension
Eligibility:
All Genders
19-110 years
Phase:
PHASE2
Brief 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 ...
Detailed 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
Eligibility Criteria
Inclusion
- Age greater than 18 years.
- GFR estimated by CKD-EPI formula \< 45 ml/min/1.73 m2 but ≥ 15 mL/min/1.73 m2 using IDMS-calibrated creatinine.
- Hypertension. Using AOBP monitoring, BP of ≥ 130/80 mmHg.
- 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. In patients with eGFR \< 45 ml/min/1.73 m2 and serum K \> 5.2 mEq/L
Exclusion
- 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.
- Expected to receive renal replacement therapy within the next 6 months.
- Myocardial infarction, heart failure hospitalization, or stroke ≤ 12 weeks prior to randomization.
- 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).
- Known hypersensitivity to thiazide or spironolactone.
- Clinic AOBP \<110 mmHg systolic at their first visit
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 12 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05222191
Start Date
February 1 2022
End Date
December 12 2023
Last Update
August 14 2023
Active Locations (1)
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1
Richard L Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202