Chronic Kidney Disease Trial, Recruiting NCT05917795 Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Condition: Chronic Kidney Disease
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Chronic Kidney Disease Trial, Recruiting

NCT05917795
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults between 18 and 70 years of age
  • People with a Body Mass Index (BMI) of 35 or higher (a measure of body weight relative to height)
  • People with serious kidney disease where the kidneys are working at less than 30% of normal function, and who are expected to reach complete kidney failure at least 6 to 12 months before needing dialysis — or people already receiving haemodialysis (a blood-filtering treatment done at a clinic) where kidney failure is considered permanent
  • People who have not been placed on a kidney transplant waiting list specifically because their BMI is 35 or above, based on the transplant centre's rules
  • People who have agreed to take part by signing a consent form

Who may not be able to join:

  • People currently receiving peritoneal dialysis (a type of dialysis done through the abdomen at home)
  • People who have had bleeding in the stomach or oesophagus (food pipe) within the past six months
  • People who have had an active cancer diagnosis within the last five years
  • People who have had a heart attack in the past six months, or who have severe heart failure (classified as Class III or IV)
  • People who have previously had surgery on the stomach, oesophagus, or duodenum (the first part of the small intestine)
  • People for whom the procedure is not considered technically possible by the specialist performing it
  • People showing signs of an active infection
  • People taking blood-thinning or anti-clotting medications that cannot be safely stopped, except for low-dose aspirin (100mg or less)
  • People with current drug or alcohol misuse problems
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study period
  • People already enrolled in another clinical trial
  • People for whom general anaesthesia is not safe or suitable
  • People excluded for other medical reasons at the investigators' discretion
  • People who do not agree to sign the consent form

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
24 September 2023
Est. completion
1 July 2027

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Kidney transplant list inclusion

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov