Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Kidney Transplant Recipient.

Recruiting

• Conditions: type1diabetes; Renal Failure; End Stage Renal Disease
• Interventions: Other: Pancreatic islet transplantation after kidney transplantation

• Registration Number: NCT05662267
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-10
• Status Verified: 2022-12
• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-21
• Last Update Submitted: 2022-12-21
• Study First Posted: 2022-12-22
• Last Update Posted: 2022-12-22
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France