What side effects are associated with this type of intervention?

Common treatments for kidney failure, such as spironolactone (an aldosterone blocker), can have several side effects. These include hyperkalemia (elevated potassium levels), which is particularly concerning in older women and those with pre-existing conditions like hypertension, renal failure, or diabetes. There is also a theoretical risk of breast cancer, although no definitive evidence supports this, and potential feminization of male fetuses if taken during pregnancy. Mineralocorticoid receptor antagonists, in general, can lead to hyperkalemia and may require careful monitoring of potassium levels and renal function.

What prior FDA approvals exist?

FDA-approved treatments for kidney failure that involve aldosterone blockade include spironolactone, eplerenone, and finerenone. These drugs work by blocking the effects of aldosterone, a hormone that can contribute to high blood pressure and heart damage. Spironolactone is commonly used to prevent heart failure and related deaths in patients without dialysis, while eplerenone and finerenone have shown benefits in improving renal outcomes and reducing mortality in patients with chronic kidney disease and heart failure. These treatments aim to manage complications associated with kidney failure and improve patient outcomes.

What other types of research exist?

Promising alternatives to spironolactone for kidney failure patients include new compounds that block aldosterone synthesis, which are currently in Phase II studies and showing positive results. Additionally, SGLT2 inhibitors like dapagliflozin have been approved for treating chronic kidney disease and have demonstrated cardiovascular and renal benefits.

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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

Must not have

Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone)

Scheduled living related donor renal transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Pivotal Trial

Summary

This trial tests if spironolactone, a pill that blocks a harmful hormone, can reduce heart problems in dialysis patients. These patients are at high risk of heart failure and death, and the pill aims to lower blood pressure and protect their hearts. Spironolactone has been shown to effectively lower blood pressure in patients with resistant hypertension.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on a medication like spironolactone or eplerenone and cannot stop.

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I am scheduled for a kidney transplant from a living relative.

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I am not in a trial for drugs that interact with spironolactone.

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

Awards & Highlights

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.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Aldosterone blockers, such as spironolactone, work by inhibiting the action of aldosterone, a hormone that increases sodium and water retention, leading to high blood pressure and further kidney damage. By blocking aldosterone, these medications help reduce blood pressure and prevent fluid overload, which is crucial for patients with kidney failure to avoid complications like heart failure. Other common treatments include ACE inhibitors and ARBs, which also lower blood pressure and reduce proteinuria, thereby slowing the progression of kidney disease. Sodium-glucose co-transporter 2 (SGLT2) inhibitors are another class that helps reduce glucose reabsorption in the kidneys, lowering blood sugar levels and providing renal protection. These treatments are vital for managing symptoms and slowing the progression of kidney failure, improving patient outcomes.

Effect of mineralocorticoid receptor antagonists on proteinuria and progression of chronic kidney disease: a systematic review and meta-analysis.