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Thiazide-like Diuretic
Spironolactone + Chlorthalidone for Kidney Failure and High Blood Pressure (SPICE PILOT Trial)
Phase 2
Recruiting
Led By Rajiv Agarwal, MD
Research Sponsored by Indiana Institute for Medical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
SPICE PILOT Trial Summary
This trial is testing whether a combination of two drugs can improve blood pressure control and reduce the risk of hyperkalemia (high potassium levels) in patients with chronic kidney disease and poorly controlled hypertension.
Eligible Conditions
- Kidney Failure
- High Blood Pressure
SPICE PILOT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Systolic Automated Office Blood Pressure from baseline to 12 weeks between arms
Secondary outcome measures
Change in logarithmically transformed albumin/creatinine ratio from baseline to 12 weeks between arms
Side effects data
From 2022 Phase 4 trial • 79 Patients • NCT021690898%
Hypotension
5%
Hyperkalemia
5%
Diabetes related
5%
Infection
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
3%
Surgical
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo
SPICE PILOT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Spironolactone + ChlorthalidoneExperimental Treatment2 Interventions
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.
Group II: Spironolactone + PlaceboActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
FDA approved
Chlorthalidone
FDA approved
Find a Location
Who is running the clinical trial?
Indiana Institute for Medical ResearchLead Sponsor
3 Previous Clinical Trials
701 Total Patients Enrolled
Rajiv Agarwal, MDPrincipal InvestigatorIndiana Institute for Medical Research; Roudebush VA Medical Center
5 Previous Clinical Trials
517 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken certain medications for high blood pressure or potassium supplements in the last 12 weeks.You are likely to need kidney replacement treatment within the next 6 months.You are allergic to thiazide or spironolactone.You are older than 18 years old.Your kidney function, measured by GFR, is below 45 mL/min/1.73 m2 but above 15 mL/min/1.73 m2 using a specific formula.Your blood pressure is consistently higher than 130/80 mmHg when measured using a specific method.Your blood potassium level needs to be between 3.5 and 5.2 mEq/L at the time of enrollment. If you have kidney function below a certain level and your blood potassium is higher than 5.2 mEq/L, you may not be eligible.Your blood pressure is less than 110 mmHg when checked at the clinic.You had a heart attack, were hospitalized for heart failure, or had a stroke within the last 12 weeks before the study starts.You are taking medication for high blood pressure, and at least one of the medications is an ACE inhibitor, ARB, or beta-blocker.
Research Study Groups:
This trial has the following groups:- Group 1: Spironolactone + Placebo
- Group 2: Spironolactone + Chlorthalidone
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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