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

End Stage Renal Disease Clinical Trial

— KA-IAK  

Official title:

Targeted Trial Emulation of Kidney Alone Versus Islet-After-Kidney in Type 1 Diabetic Transplant Recipients : a French Nationwide Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05662267
• Other study ID #: HLJ_2022_03
• Secondary ID: DEC19-483
• Status: Recruiting
• Start date: March 10, 2020
• Est. completion date: March 2023

Study information

• Verified date: December 2022
• Source: University Hospital, Lille
• Contact: Medhi Maanaoui, MD,PhD
• Phone: 0320445962
• Email: mehdi.maanaoui[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• End Stage Renal Disease
• Kidney Failure, Chronic
• Renal Failure
• type1diabetes

Intervention

Other:
• Pancreatic 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.

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Agence de La Biomédecine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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