End Stage Renal Disease, Renal Failure, type1diabetes
Conditions
Keywords
Type 1 Diabetes, Pancreatic Islet Transplantation, Kidney Transplantation
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.
Interventions
OTHERPancreatic 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.
Sponsors
University Hospital, Lille
Agence de La Biomédecine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-graft survival | 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. | Patient-graft survival by death-uncensored graft survival, i.e. the return to dialysis or death |
Secondary
| Measure | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMedhi Maanaoui, MD,PhD
University Hospital, Lille
Outcome results
None listed