Clinical trial NCT05662267: Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Kidney Transplant Recipient.
Official title: Targeted Trial Emulation of Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Transplant Recipients : a French Nationwide Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: type1diabetes
Renal Failure
End Stage Renal Disease
Keywords: Type 1 Diabetes
Pancreatic Islet Transplantation
Kidney Transplantation
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Agence de La Biomédecine
First posted: 2022-12-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French patients with type 1 diabetes, transplanted between 2000 and 2017 with a kidney transplant

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Graft failure defined by death-uncensored graft survival, i.e. the return to dialysis or death
timeFrame: 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 outcomes:
measure: Patient survival
timeFrame: 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
measure: Death-censored graft survival
timeFrame: 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
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Medhi Maanaoui, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: