A New Approach for Kidney Cachexia in Dialysis Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates whether a multimodal treatment that blends exercise, dietary advice, and anti-inflammatory supplements can improve muscle mass, strength, fatigue, appetite, and quality of life for adults with kidney cachexia who are undergoing maintenance hemodialysis. Eligible participants are adults with CKD stage 5 on hemodialysis for more than 3 months and evidence of recent weight loss or low BMI, decreased function, and fatigue. The approach compares the MMIEAD intervention to routine kidney care to determine if the combined strategy yields better outcomes than standard care. The study is led by Queen's University, Belfast, and will take place at two affiliated health care trusts in Northern Ireland. There is currently no standard therapy for kidney cachexia, so this trial aims to explore a potential multi-target treatment option.

Why it matters

Who can join: the full rules

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.

Where it's running

• Northern Health and Social Care Trust
  Antrim, County Antrim, United Kingdom Recruiting
• South Eastern Health and Social Care Trust
  Belfast, County DOWN, United Kingdom Recruiting

Study contacts

• Study coordinator: Joanne Reid, PhD
• Email: j.reid@qub.ac.uk
• Phone: 02890972459

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.