Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Kidney Transplant Recipient. (KA-IAK)

University Hospital, Lille

Status: Enrolling

Conditions: Renal Failure; End Stage Renal Disease; type1diabetes

Treatments: Other: Pancreatic islet transplantation after kidney transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT05662267

HLJ_2022_03

DEC19-483 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Islet-after-kidney group

Description:

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

Description:

Patients with type 1 diabetes with a kidney transplant who did not receive an islet transplantation belong to the " Kidney alone group ".

Treatment:

Other: Pancreatic islet transplantation after kidney transplantation