KA-IAK: Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Kidney Transplant Recipient.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 ". |
Other: Pancreatic islet transplantation after kidney transplantation
Pancreatic islet transplantation consists in the intrahepatic transplantation of pancreatic islets, as a result of enzymatic digestion of a deceased-donor pancreas.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is aged over 18
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With type 1 diabetes
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With End-Stage Renal disease
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Transplanted with a kidney
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Between 2000 and 2017
Exclusion Criteria:
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Patients with type 2 diabetes
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Patients with a previous pancreatic transplantation with a pancreatic graft functioning at the time of kidney transplantation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hop Claude Huriez Chu Lille | Lille | France | 59037 |
Sponsors and Collaborators
- University Hospital, Lille
- Agence de La Biomédecine
Investigators
- Principal Investigator: Medhi Maanaoui, MD,PhD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HLJ_2022_03
- DEC19-483