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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
Age greater than 18 years
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
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are older than 18 years old.
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You are taking medication for high blood pressure, and at least one of the medications is an ACE inhibitor, ARB, or beta-blocker.

SPICE PILOT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

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 • NCT02169089
8%
Hypotension
5%
Diabetes related
5%
Hyperkalemia
5%
Infection
3%
Breast tenderness/Gynecomastia
3%
Chest pain/discomfort
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

Chlorthalidone (Thiazide-like Diuretic) Clinical Trial Eligibility Overview. Trial Name: NCT05222191 — Phase 2
Kidney Failure Research Study Groups: Spironolactone + Placebo, Spironolactone + Chlorthalidone
Kidney Failure Clinical Trial 2023: Chlorthalidone Highlights & Side Effects. Trial Name: NCT05222191 — Phase 2
Chlorthalidone (Thiazide-like Diuretic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05222191 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for this research extend past seventy years old?

"This study is only taking patients that are younger than 110 and older than 19."

Answered by AI

Has Spironolactone completed clinical trials and been cleared by the FDA?

"Spironolactone has received a score of 2 from our team at Power. Phase 2 trials have some evidence supporting safety, but there is no data yet to suggest the medication's efficacy."

Answered by AI

How do I sign up for this clinical research program?

"This trial is looking for 24 people suffering from kidney failure that are between 19 and 110 years old. The most important criteria that applicants must meet are as follows: They must be taking at least one antihypertensive drug, with one of those drugs being either an ACE inhibitor or ARB or a beta-blocker at the time of randomization. Additionally, their serum K level needs to be 3.5 to 5.2 mEq/L at the time of randomization. For patients with eGFR < 45 ml/min/1.73 m2 and serum K > 5.2 mEq/L"

Answered by AI

Are we able to enroll new participants in this clinical trial at the moment?

"The trial, which was first announced on February 1st, 2022 is still recruiting participants. This information can be found on clinicaltrials.gov"

Answered by AI

How many people suffering from this disease will be given the chance to participate in this trial?

"The clinicaltrials.gov website does show that this trial is open and looking for patients right now. This trial was first posted on February 1st, 2022 and has not had any changes since then. They are only seeking 24 participants at a single site."

Answered by AI
~8 spots leftby Mar 2025