End Stage Renal Disease Clinical Trial
— ESGiTXKidneyOfficial title:
Prospective Pilot Study for the Evaluation of Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates
NCT number | NCT05917795 |
Other study ID # | 5764 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 24, 2023 |
Est. completion date | July 1, 2027 |
Verified date | June 2023 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | July 1, 2027 |
Est. primary completion date | July 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. - |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Universitario A. Gemelli IRCCS | Rome |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kidney transplant list inclusion | 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 | 12 months |
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