Spironolactone in CKD Enabled by Chlorthalidone: PILOT (SPICE PILOT)
Renal Insufficiency, Chronic Hypertension
About this trial
This is an interventional treatment trial for Renal Insufficiency focused on measuring Spironolactone, Chlorthalidone, Chronic Kidney Disease, Hypertension, Thiazide Diuretic, Potassium Sparring Diuretic
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Richard L Roudebush VA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Spironolactone + Placebo
Spironolactone + Chlorthalidone
Subjects with stage 3B/4 chronic kidney disease and poorly controlled hypertension will be randomized into two groups: one receiving spironolactone and placebo and one receiving spironolactone and chlorthalidone. At randomization, subjects will begin at 25 mg spironolactone and 6.25 mg placebo/chlorthalidone daily.
Subjects with stage 3B/4 chronic kidney disease and poorly controlled hypertension will be randomized into two groups: one receiving spironolactone and placebo and one receiving spironolactone and chlorthalidone. At randomization, subjects will begin at 25 mg spironolactone and 6.25 mg placebo/chlorthalidone daily.