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Could a common heart drug help kids on dialysis fight anemia?

NCT ID NCT07715318

Disease control Sponsor: Ain Shams University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether spironolactone, a drug usually used for heart failure and high blood pressure, can help treat anemia in children aged 6–18 who are on hemodialysis. Participants take spironolactone daily for 12 weeks alongside standard care, and researchers measure whether it reduces the dose of erythropoietin needed to manage their anemia. The study also monitors safety, especially potassium levels, in this vulnerable group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
spironolactone
What this could lead to
If it works, this could offer a new way to manage anemia in children on dialysis, potentially reducing their need for erythropoietin injections.
What could go wrong
This is a small, early-phase trial with only 40 participants, so results may not apply broadly. Spironolactone can raise potassium levels, which is a risk in kidney patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female patients with ages 6-18 years old undergoing regular hemodialysis (3 sessions per week for at least 6 months) 2. Pediatric patients weighing between 25 kg and 50 kg. 3. Patients with potassium level less than 5.5 mmol/L and produce urine. 4. Anemic patients "have Hb values between 9.5 and 12.5 g/dl, transferrin saturation (TSAT) less than 20%) 5. patients have been receiving stable rHuEpo therapy administered intravenously (IV) or subcutaneously (SC) for at least 8 weeks prior to randomization 6. Patients suffering from iron- restricted erythropoiesis - Exclusion Criteria: 1. Patients with acute renal insufficiency. 2. Patients with hyperkalemia (≥5.5 mmol/L) and hyponatremia (blood level less than135 mEq/L) 3. Patients with liver disease (AST \& ALT greater than 3times upper limit normal) 4. Patients with hypersensitivity to spironolactone. 5. Patients scheduled for a living donor kidney transplant within 6 weeks following consent. 6. Current or recently enrolled in another investigational drug study (within 30 days). 7. Uncontrolled pre-dialysis supine diastolic blood pressure greater than the 95th percentile for height, gender, and age on more than two occasions in the 2 weeks prior to screening. \-

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Conditions

The condition(s) this trial relates to.

anemia chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia

How to take part

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  1. The official record

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