Endoscopic sleeve gastroplasty for obese kidney transplant candidates

Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates

This study is testing if a procedure called endoscopic sleeve gastroplasty can help obese patients with kidney disease lose enough weight to qualify for a kidney transplant.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other)
• Locations: 1 site (Rome)
• Trial ID: NCT05917795 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with a BMI of 35 kg/m² or higher and chronic kidney disease who are not currently listed for transplantation due to their weight.

Not a fit: Patients on peritoneal dialysis or those with recent upper gastrointestinal bleeding or active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enable obese kidney transplant candidates to qualify for transplantation by achieving a healthier BMI.

How similar studies have performed: While ESG is a recognized procedure for weight loss, this specific application for kidney transplant candidates is novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Rome

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy (RECRUITING)

Conditions: Obesity, Morbid, End Stage Renal Disease, Kidney Transplantation, Endoscopic Sleeve Gastroplasty