Spironolactone in Chronic Kidney Disease Enabled by Chlorthalidone
R
Rajiv Agarwal
Primary Investigator
Overview
Our pilot study will focus on the
potential dosages and effectiveness by which SPL and CTD will be prescribed.
The effects of these two simple and inexpensive drugs have not been evaluated
so far. This addresses an effective way to treating people with CKD who have
poorly controlled hypertension.
Description
To
test the notion that SPL-CTD combination therapy should be added to the existing
regimen of those with moderate to advanced CKD and uncontrolled hypertension, we
propose a single center, placebo-controlled, double-blind, randomized
controlled pilot trial of CTD/placebo. All patients will receive open-label SPL
25 mg once daily (QD), a fixed-dose at randomization (Figure 1). Randomization
will be stratified by loop diuretic use. Those on loop diuretics, at the time
of randomization, will decrease their dose of the loop diuretic by half to
reduce the risk of AKI and excessive BP lowering. After randomization, a home
monitor will be provided to enable BP monitoring.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
chronic kidney disease
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- 1. Age greater than 18 years.2. GFR estimated by CKD-EPI formula < 45 ml/min/1.73m2 but ≥15 mL/min/1.73m2 using IDMS-calibrated creatinine. In patients with eGFR <45 ml/min/1.73m2 guidelines caution against the use of SPL (6), which is why we have chosen this threshold.3. Hypertension. Using AOBP monitoring, the ACC/AHA guidelines define hypertension as BP of ≥130/80 mmHg (5). Patients whose clinic AOBP is less than 110mmHg systolic at their first visit will be excluded from further participation in the study.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 (19) .5. Serum K 3.5 to 5.2 mEq/L at the time of randomization. In patients with eGFR <45 ml/min/1.73m2 and serum K >5.2 mEq/L, the risk of hyperkalemia with SPL would be very high which is why we exclude such patients. In patients who have serum K <3.5 mEq/L, K supplementation would be required which would confound the results.
Exclusion Criteria:
- 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.
Updated on
03 May 2024.
Study ID: 12672, NEPH-IIMR-SPICE
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