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Spironolactone + Chlorthalidone for Kidney Failure and High Blood Pressure (SPICE PILOT Trial)
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.
- Kidney Failure
- High Blood Pressure
SPICE PILOT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSPICE PILOT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 4 trial • 79 Patients • NCT02169089SPICE PILOT Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Spironolactone + Placebo
- Group 2: Spironolactone + Chlorthalidone
- 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.
- 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.
Frequently Asked Questions
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."
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."
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"
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"
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."
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