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Mineralocorticoid Receptor Antagonist

Spironolactone for Kidney Failure (ACHIEVE Trial)

Phase 3

Recruiting

Led By Michael Walsh, MD, PhD

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥45 years or ≥18 with a history of diabetes

On hemodialysis prescribed at least 2 treatments per week or on peritoneal dialysis prescribed with at least 1 exchange daily

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

ACHIEVE Trial Summary

This trial will test whether spironolactone reduces heart failure and heart related death in patients that require dialysis.

Who is the study for?

This trial is for adults on dialysis due to kidney failure, who've been receiving treatment for at least 90 days. It's open to those aged 45 and above or adults over 18 with diabetes. Participants must not be pregnant, breastfeeding, have high potassium levels, known allergies to spironolactone, or be in another similar drug trial.Check my eligibility

What is being tested?

The study tests if Spironolactone can reduce heart failure and related deaths in patients on dialysis. Half of the participants will receive Spironolactone while the other half will get a placebo (a pill with no active drug), to compare outcomes between the two groups.See study design

What are the potential side effects?

Spironolactone may cause side effects like increased potassium levels which can affect heart rhythm, breast enlargement in men, menstrual irregularities in women, dehydration symptoms such as dry mouth/thirsty feeling or muscle cramps.

ACHIEVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 45 years old or I am 18 or older with diabetes.

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I am on dialysis, either hemodialysis twice a week or peritoneal dialysis daily.

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I have been on dialysis for at least 90 days.

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I am on dialysis, either hemodialysis twice a week or peritoneal dialysis daily.

ACHIEVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CV Death or Hospitalization for Heart Failure

Secondary outcome measures

All-cause Hospitalization

All-cause death

Cause specific death

+2 more

ACHIEVE Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Spironolactone 25 MG TabletActive Control1 Intervention

25 mg of active spironolactone in tablet form

Group II: Placebo Oral TabletPlacebo Group1 Intervention

A tablet with no active medication that will be an exact match of the active spironolactone in taste and appearance

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,344 Previous Clinical Trials

26,450,667 Total Patients Enrolled

4 Trials studying Kidney Failure

5,488 Patients Enrolled for Kidney Failure

Population Health Research InstituteLead Sponsor

155 Previous Clinical Trials

677,162 Total Patients Enrolled

Michael Walsh, MD, PhDPrincipal InvestigatorMcMaster University

2 Previous Clinical Trials

224 Total Patients Enrolled

1 Trials studying Kidney Failure

200 Patients Enrolled for Kidney Failure

Media Library

Spironolactone (Mineralocorticoid Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03020303 — Phase 3

Kidney Failure Research Study Groups: Placebo Oral Tablet, Spironolactone 25 MG Tablet

Kidney Failure Clinical Trial 2023: Spironolactone Highlights & Side Effects. Trial Name: NCT03020303 — Phase 3

Spironolactone (Mineralocorticoid Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03020303 — Phase 3

Frequently Asked Questions

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

Has the FDA cleared Spironolactone 25 MG Tablet for public use?

"Spironolactone 25 MG Tablet has received a safety score of 3."

Answered by AI

Are there any room for new participants in this research project?

"The listed clinical trial on clinicaltrials.gov is currently looking for 2750 participants across 17 locations. The study was first posted on 7/7/2017 and updated most recently on 9/19/2022."

Answered by AI

Could you walk me through the conditions Spironolactone 25 MG Tablet is meant to treat?

"Spironolactone 25 MG Tablet is the most common medication used to treat primary hyperaldosteronism. This drug can also be prescribed for other conditions, such as cirrhosis of the liver and acne."

Answered by AI

At how many facilities is this clinical trial being conducted?

"Patients are being accepted at Queen's University, CHU de Quebec L'Hotel-Dieu, Foothills Hospital and other locations."

Answered by AI

Are there other instances of Spironolactone 25 MG Tablet being used in a clinical setting?

"At the moment, 29 ongoing studies are evaluating Spironolactone 25 MG Tablet's efficacy. Out of these 8 are in Phase 3. Most investigations into Spironolactone 25 MG Tablet are located in Miami, Florida; however, there are 293 total sites running clinical trials for this drug."

Answered by AI

How many people can enroll in this clinical trial?

"That is correct. The online clinicaltrial registry confirms that the study is still recruiting individuals. This specific trial was posted on 7/7/2017 and updated as recently as 9/19/2022. They are looking for 2750 participants at 17 different locations."

Answered by AI