Spironolactone in CKD Enabled by Chlorthalidone: PILOT
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.
Conditions:
🦠 Renal Insufficiency 🦠 Chronic Hypertension
🗓️ Study Start (Actual) 1 February 2022
🗓️ Primary Completion (Estimated) 12 December 2023
✅ Study Completion (Estimated) 12 December 2023
👥 Enrollment (Estimated) 24
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Indianapolis, Indiana, United States

📋 Eligibility Criteria

Description

    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 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

    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.
    • 6. Clinic AOBP \<110 mmHg systolic at their first visit
Ages Eligible for Study: 19 Years to 110 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 18 January 2022
  • First Submitted that Met QC Criteria 1 February 2022
  • First Posted 3 February 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 August 2023
  • Last Update Posted 14 August 2023
  • Last Verified August 2023