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NCT05662267
Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Kidney Transplant Recipient.
Conditions: type1diabetes, Renal Failure, End Stage Renal Disease
Sex: All
Ages: 18 Years – N/A
Enrollment: 500
Sponsor: University Hospital, Lille
Location: France
Summary
Islet transplantation is associated with a benefit on glycaemic control compared to optimized insulin therapy in recent clinical trials.
However, there is a lack of evidence concerning the long-term impact of islet transplantation on type 1 diabetic kidney transplant recipients' prognosis.
The objective of the study is to assess the impact of islet transplantation in patients with type 1 diabetes and a kidney transplantation on the risk of graft failure.
Every type 1 diabetic recipient transplanted with a kidney in France between 2000 and 2017 is included.
Patients transplanted with pancreatic islets are compared to controls treated with insulin alone according to a matching method based on time-dependent propensity scores which allow to ensure patients comparability at the time of islet transplantation.
Time-dependent propensity scores are built according to variables associated with both the probabilities of being transplanted with islets and the outcome of interest.
These variables are assessed by a direct acyclic graph.
The primary outcome consists in death-uncensored graft survival, defined by death or return to dialysis.
Secondary outcomes include the risk of death, or the risk of death-censored graft survival.
Eligibility Criteria
Inclusion Criteria:Patient is aged over 18With type 1 diabetesWith End-Stage Renal diseaseTransplanted with a kidneyBetween 2000 and 2017Exclusion Criteria:Patients with type 2 diabetesPatients with a previous pancreatic transplantation with a pancreatic graft functioning at the time of kidney transplantation.
Source: ClinicalTrials.gov (NCT05662267). StuddyBuddy aggregates publicly available trial information.