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| ID | Type | Description | Link |
|---|---|---|---|
| DEC19-483 | Other Identifier | Number register data CHU Lille |
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| Name | Class |
|---|---|
| Agence de La Biomédecine | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Islet-after-kidney group | 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 | Patients with type 1 diabetes with a kidney transplant who did not receive an islet transplantation belong to the " Kidney alone group ". |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pancreatic islet transplantation after kidney transplantation | Other | Pancreatic islet transplantation consists in the intrahepatic transplantation of pancreatic islets, as a result of enzymatic digestion of a deceased-donor pancreas. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-graft survival | Patient-graft survival 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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French patients with type 1 diabetes, transplanted between 2000 and 2017 with a kidney transplant
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| Name | Affiliation | Role |
|---|---|---|
| Medhi Maanaoui, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Claude Huriez Chu Lille | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |