Predicting diabetes outcomes after a kidney transplant
Official title: Post-Transplant Diabetes Outcomes Prediction Through Machine Learning and Deep Phenotyping
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07512804 · Data updated 2026-11-12
This project will try to see if whole genome sequencing can help predict outcomes for adults who develop new diabetes after a kidney transplant.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Status | Recruiting |
| Started | August 31, 2024 |
| Main results expected | February 28, 2027 |
| Study ends | February 28, 2027 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT07512804 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 70 who received a kidney transplant and were diagnosed with new-onset post-transplant diabetes between 1 and 10 years before enrollment, and who can give informed consent, are ideal candidates.
✕Probably not a fit
Patients with active cancer, active infection, prior recurrent biopsy-proven renal disease, severe heart failure, or hepatic failure are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults who received a kidney transplant and developed new-onset diabetes 1 to 10 years later will undergo whole genome sequencing and clinical data collection at a single center in Rome. Researchers will compare genetic findings with patients' clinical courses to look for genetic patterns linked to complications and long-term outcomes. Participants with active cancer, active infection, recurrent biopsy-proven renal disease, severe heart failure (NYHA III-IV), or hepatic failure are excluded. The goal is to identify genetic predictors that could guide personalized post-transplant diabetes management.
Why it matters
Potential benefit: If successful, this could help doctors predict which transplant recipients are at higher risk for complications and tailor follow-up and treatment more precisely.
How similar studies have gone: Some prior genetic studies have suggested links between variants and diabetes risk, but using whole genome sequencing specifically to predict post-transplant diabetes outcomes is largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * age between 18 and 70 years old, * kidney graft recipients with a diagnosis of de novo post-transplant diabetes between 1 and 10 years from the time of enrollment, * ability to sign a valid informed consent form. Exclusion Criteria: * diagnosis of neoplasia, * the presence of an active infection, * previous biopsy-proven diagnosis of a recurrent renal disease, * NYHA class III-IV heart failure, * hepatic failure.
Where it's running
-
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Nefrologia
Roma, Italy Recruiting
Study contacts
- Principal investigator: Giuseppe Grandaliano — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Giuseppe Grandaliano
- Email: giuseppe.grandaliano@unicatt.it
- Phone: +390630159983
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.