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Can a new iron strategy help kidney dialysis patients fight anemia?

NCT ID NCT06884280

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at different ways to give iron to people with kidney failure who are on peritoneal dialysis. Participants will get either high-dose or low-dose intravenous iron, or oral iron tablets. The main goal is to see if a larger trial is possible by checking how many people join, stay, and complete the study over 12 months.

What this could mean

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

Active substance
Iron (intravenous iron isomaltoside 1000 or oral ferrous sulfate)
What this could lead to
If successful, this could help design a larger study to find the best way to treat anemia in people on peritoneal dialysis, potentially improving energy and quality of life.
What could go wrong
This is a small feasibility trial with only 30 participants, so results may not apply to everyone. It is testing whether a bigger study is possible, not yet proving which iron treatment works best.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 30 people

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

Started

Nov 2025

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 years and older

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: * Males and females aged ≥18 years. * Able to give informed consent * Serum ferritin \<700ug/L * Transferrin saturation level \<40% * No intravenous iron for last 4 weeks before randomisation (patients may be pre-identified and included after 4-week washout period) * Received maintenance peritoneal dialysis therapy for at least 4 weeks * Expected to remain on peritoneal dialysis therapy for duration of study Exclusion Criteria: * Inadequate dialysis deemed by responsible clinician * Probability of need for transfusion within 1 week of enrolment * On or received a HIF-PHI in the past 4 weeks * Anticipated major surgery that the responsible clinician feels will impact response to treatment * Haemochromatosis / haemosiderosis or ALT \>x3 normal * Are deemed to be most suited to best-supportive or end-of-life care at time of screening * Women of childbearing potential not using effective means of contraception * Have been involved in another medicinal study (CTIMP) within past 4 weeks * Known allergy or adverse reaction to oral or intravenous iron preparations * CRP \>50, TSATs \>40%, SF \>700 at time of recruitment * Active infection, HIV, active Hep B or C * Are unable or unwilling to consent to or complete the study procedures

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hull University Teaching Hospitals NHS Trust

    RECRUITING

    Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom

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