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

NCT ID: NCT05662267

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2023-03-31

Brief Summary

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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

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Conditions

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type1diabetes Renal Failure End Stage Renal Disease

Keywords

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Type 1 Diabetes Pancreatic Islet Transplantation Kidney Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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".

No interventions assigned to this 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 ".

Pancreatic islet transplantation after kidney transplantation

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agence de La Biomédecine

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medhi Maanaoui, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Claude Huriez Chu Lille

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Medhi Maanaoui, MD,PhD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Other Identifiers

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DEC19-483

Identifier Type: OTHER

Identifier Source: secondary_id

HLJ_2022_03

Identifier Type: -

Identifier Source: org_study_id