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Completed

NCT Number: NCT05662267

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

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.

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Key information

Conditions

Type1diabetes Autoimmune Diseases Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 1 Disease Attributes End Stage Renal Disease Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Immune System Diseases Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Failure Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Claude Huriez Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pancreatic islet transplantation after kidney transplantation

Other

Pancreatic islet transplantation consists in the intrahepatic transplantation of pancreatic islets, as a result of enzymatic digestion of a deceased-donor pancreas.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Agence de La Biomédecine

Registry information

Official study title

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

Acronym: KA-IAK

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 22, 2022
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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