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

May 11, 2026 updated by: University Hospital, Lille

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

327

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Hop Claude Huriez Chu Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

French patients with type 1 diabetes, transplanted between 2000 and 2017 with a kidney transplant

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 ".
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Outcome Measure
Time Frame
Patient 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, assessed up to 240 months
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Agence de La Biomédecine

Investigators

  • Principal Investigator: Medhi Maanaoui, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2020

Primary Completion (Actual)

November 2, 2023

Study Completion (Actual)

November 2, 2023

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLJ_2022_03
  • DEC19-483 (Other Identifier: Number register data CHU Lille)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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