Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Kidney Transplant Recipient.

Study Overview
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Brief Summary
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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.

Official Title
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Targeted Trial Emulation of Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Transplant Recipients : a French Nationwide Cohort Study

Conditions
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type1diabetes, Renal Failure, End Stage Renal Disease

Intervention / Treatment
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* Other: Pancreatic islet transplantation after kidney transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is aged over 18 With type 1 diabetes With End-Stage Renal disease Transplanted with a kidney Between 2000 and 2017 Exclusion Criteria: Patients with type 2 diabetes Patients with a previous pancreatic transplantation with a pancreatic graft functioning at the time of kidney transplantation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Islet-after-kidney group<br>Patients with type 1 diabetes with a kidney transplant received or not an islet transplantation after kidney transplantation. As soon as they received an islet transplantation, they belong to the Islet-after-kidney group. | |
| Kidney alone group<br>Patients with type 1 diabetes with a kidney transplant who did not receive an islet transplantation belong to the  Kidney alone group . | Other: Pancreatic islet transplantation after kidney transplantation<br>* Pancreatic islet transplantation consists in the intrahepatic transplantation of pancreatic islets, as a result of enzymatic digestion of a deceased-donor pancreas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft failure defined by death-uncensored graft survival, i.e. the return to dialysis or death |  | From the date of islet transplantation (or time-point equivalent in the control group) until the date of death from any cause or return to dialysis, whichever comes first, assessed up to 240 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient survival |  | From the date of islet transplantation (or time-point equivalent in the control group) until the date of death from any cause, assessed up to 240 months | 
| Death-censored graft survival |  | From the date of islet transplantation (or time-point equivalent in the control group) until the date of death from any cause, assessed up to 240 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Pancreatic Islet Transplantation, Kidney Transplantation