Could a triple therapy beat kidney muscle wasting?
NCT ID NCT07107087
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
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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
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Northern Health and Social Care Trust
RECRUITINGAntrim, County Antrim, BT41 2RL, United Kingdom
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South Eastern Health and Social Care Trust
RECRUITINGBelfast, County DOWN, BT16 1RH, United Kingdom
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