Endoscopic sleeve gastroplasty for obese kidney transplant candidates

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 pilot interventional study evaluates the effectiveness of endoscopic sleeve gastroplasty (ESG) in reducing body mass index (BMI) in obese patients with end-stage renal disease who are candidates for kidney transplantation. The goal is to help participants achieve a BMI below 35 kg/m² within 12 months to qualify for the transplant waiting list. Participants will undergo ESG and will be monitored for weight loss, quality of life, and obesity-related comorbidities for a total of 24 months, including 12 months before and after transplantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patients (i.e., age between 18 and 70 years).
* BMI ≥ 35 kg/m²;
* Patients with chronic kidney disease (CKD) G4-G5 (glomerular filtration rate \[GFR\] \<30ml/min/1.73 m2) who are expected to reach end-stage kidney disease (ESKD) at least 6 to 12 months before anticipated dialysis initiation (pre-emptive transplant candidates) or patients already on haemodialysis when medically stable and kidney failure deemed irreversible;
* Patients not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2);
* Signed informed consent.

Exclusion Criteria:

* Patients on peritoneal dialysis
* Upper gastro-intestinal bleeding (gastric or oesophageal) in the previous six months;
* Ongoing or active malignancy during the last 5 years
* Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification;
* Previous stomach, oesophagus or duodenum surgery;
* Technical non-feasibility in the opinion of the endoscopist;
* Clinical signs of active infection;
* Concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg);
* Active drugs or alcohol abuse;
* Pregnancy, lactation (desire to become pregnant during study duration);
* Enrolment in other clinical studies;
* Contraindication to general anaesthesia;
* Other conditions to exclude the subject in investigators opinion;
* Refusal to sign informed consent. -

Where it's running

• Fondazione Policlinico Universitario A. Gemelli IRCCS
  Rome, Italy Recruiting

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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.