Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates

Not Applicable

Recruiting

• Conditions: End Stage Renal Disease; Kidney Transplantation; Endoscopic Sleeve Gastroplasty; Obesity, Morbid
• Interventions: Procedure: Endoscopic Sleeve Gastroplasty (ESG)

• Registration Number: NCT05917795
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

The aim of this pilot prospective interventional study is to evaluate the efficacy of endoscopic sleeve gastroplasty (ESG) in allowing obese subjects (≥35 kg/m2) with end stage renal disease who need of kidney transplantation to reduce their BMI below 35 in order to be inserted in the waiting list BMI. The main question\[s\] it aims to answer are:

Is the procedure effective in reducing BMI to the target level in 12 months? Which is the effect on weight loss, quality of life and obesity-related comorbidities? Participants will undergo ESG as per standard clinical practice and followed up to 12 months before transplantation and for 12 months after transplantation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-23
• Study First Posted: 2023-06-26
• Study Start: 2023-09-24
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
kidney transplant candidates with obesity (BMI > 35 kg/m2)	Endoscopic Sleeve Gastroplasty (ESG)	Subjects with an indication to kidney transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2)

Primary Outcome Measures

Name	Time	Method
Kidney transplant list inclusion	12 months	number of patients who achieve a BMI \< 35 kg/m² within 12 months post-ESG, allowing them to be included in the kidney transplant list

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Italy