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

NCT05662267 | Unknown

• 2 other identifiers: HLJ_2022_03DEC19-483
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

type1diabetes; Renal Failure; End Stage Renal Disease

Keywords

Type 1 Diabetes; Pancreatic Islet Transplantation; Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

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

Interventions

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.

Kidney alone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patient is aged over 18
• With type 1 diabetes
• With End-Stage Renal disease
• Transplanted with a kidney
• Between 2000 and 2017

You may not qualify if:

• Patients with type 2 diabetes
• Patients with a previous pancreatic transplantation with a pancreatic graft functioning at the time of kidney transplantation.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Agence de La Biomédecine: collaborator

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Medhi Maanaoui, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medhi Maanaoui, MD,PhD

CONTACT

0320445962; mehdi.maanaoui@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 22, 2022
• Study Start: March 10, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

FR (1)