Targeted Trial Emulation of Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Transplant Recipients : a French Nationwide Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 327
- Locations
- 1
- Primary Endpoint
- Patient-graft survival
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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 ".
Intervention: Pancreatic islet transplantation after kidney transplantation (Other)
Outcomes
Primary Outcomes
Patient-graft survival
Time Frame: 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 Outcomes
- 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)