Could a triple therapy beat kidney muscle wasting?

NCT ID NCT07107087

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial tests whether combining an individualized exercise program, dietary advice, and anti-inflammatory fish oil supplements can help patients with kidney failure who are losing muscle and strength—a condition called kidney cachexia. Participants on hemodialysis at risk of cachexia will receive either this multi-modal intervention plus routine care, or routine care alone, for 12 weeks. The study focuses on whether this approach is practical and acceptable for patients and clinicians, while also measuring physical function, muscle mass, weight, quality of life, and survival. If the combination proves feasible, it could pave the way for a larger trial to see if it truly improves outcomes for 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
Multi-Modal Integrated Intervention combining Exercise, Anti-inflammatory & Dietary Advice (MMIEAD) - an individualized exercise program, oral omega-3 (fish oil) supplements, and dietary advice
What this could lead to
If this combination approach proves practical and promising, it could lead to a new supportive treatment to help dialysis patients with kidney cachexia maintain muscle, strength, and quality of life.
What could go wrong
This is a small feasibility study, not a large effectiveness trial, so it may not show clear benefits. The intervention requires significant patient effort, and adherence or practical challenges could limit its success.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

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

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: * CKD Stage 5 patients receiving maintenance HD therapy for \>3 months * Oedema-free weight loss of at least 5% in 12 months or BMI less than 20 kg/m2 * Self-reported decreased physical function/muscle strength and appetite, increased fatigue * Male or female, aged \>18 years and * Able to provide written informed consent. Exclusion Criteria: * Under 18 years of age * Patients within 3 months of initiation of HD (patients in this time frame are generally less clinically stable, many having vascular access procedures performed and with much higher rates of intercurrent events, including death and hospitalisation) * Patients experiencing weight loss due to clinically explainable reasons for example malabsorption or oesophageal blockage * Patients already receiving chronic anticoagulation therapy or with a history of bleeding with 3 months/active bleeding issues * Patients receiving immunosuppressants or immunomodulators * Patients who are pregnant or breast feeding * Patients with a hypersensitivity to any of the constituent components of the omega-3 dietary supplement * Patients who have dementia, a psychiatric disorder (who are not treated and stable) or a severe cognitive impairment which would deem them unable to give informed consent * Patients with expected survival on dialysis of \<6 months \[e.g. those with severe heart failure (New York Heart Association ≥3)\] * Patients for whom dialysis withdrawal is being considered * Patients likely to receive a live-donor transplant or transfer to peritoneal dialysis during the study duration * Patients with bilateral lower limb amputations * Patients deemed to be clinically unstable by their treating physician * Patients who are non-English speaking (not having the ability to provide informed consent, read and write English) * Patients who are currently enrolled in any study which involves exercise, fish oil/omega-3 or have been taking fish oil or omega-3 supplementation in the previous 3 months * Patients who are not able/willing to be involved.

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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

    2 sites. 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

  • Northern Health and Social Care Trust

    RECRUITING

    Antrim, County Antrim, BT41 2RL, United Kingdom

  • South Eastern Health and Social Care Trust

    RECRUITING

    Belfast, County DOWN, BT16 1RH, United Kingdom

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