Glucose Disorders Induced by Tacrolimus on Pre Transplantation Endstage Renal Disease Patients (GLITTER)
Primary Purpose
Kidney Failure, Chronic
Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
About this trial
This is an interventional diagnostic trial for Kidney Failure, Chronic
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- 1st Inscription on the kidney transplant list at Nantes University Hospital
- Hemodialysis patient in one of the participating centres
- Patient who is able to understand the proposed protocol and has given free and informed consent
- Patient with affiliation to the French social security system.
Exclusion Criteria:
- Personal history of diabetes treated or untreated
- Temporary contraindication for carcinological reasons
- Hyperimmunized patient with an Ease of Access to Transplantation score < 30
- Immunosuppressive treatment in progress
- Macrolide Allergies
- Hypersensitivity to the excipients used in the composition of tacrolimus
- Intolerance to the HGPO test
- Progressive infectious outbreak
- History of organ transplantation
- Hepatic insufficiency
- Intercurrent infectious pathology
- Patient under guardianship, curatorship, legal protection measure, or deprived of liberty
- Pregnant women, breastfeeding, or non-menopausal woman who refuses contraception
Sites / Locations
- Centre Hospitalier Départemental VendéeRecruiting
- Centre Hospitalier Universitaire NantesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tacrolimus treatment
Arm Description
Outcomes
Primary Outcome Measures
Proportion of haemodialysis patients modifying their glycemic profile receiving Tacrolimus
Secondary Outcome Measures
Full Information
NCT ID
NCT03640026
First Posted
August 17, 2018
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Departemental Vendee
1. Study Identification
Unique Protocol Identification Number
NCT03640026
Brief Title
Glucose Disorders Induced by Tacrolimus on Pre Transplantation Endstage Renal Disease Patients
Acronym
GLITTER
Official Title
Glucose Disorders Induced by Tacrolimus on Pre Transplantation Endstage Renal Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2019 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Diabetes after kidney transplantation is a frequent complication, the incidence of which varies from 7 to 45% depending on the studies and on the diagnostic criteria used. Post-transplant diabetes is an early complication, most often occurring in the first month after transplantation.
In addition to the additional health costs generated by the appearance of post-transplant diabetes, the risk of graft loss is increased by 60% and the overall mortality risk by 90%. Similarly, the development of glucose intolerance after transplantation is associated with higher mortality.
Tacrolimus treatment is therefore currently one of the most important risk factors for diabetes at the time of transplantation.
Indeed, several in vitro and in vivo animal studies have shown that tacrolimus alters pancreatic endocrine function.
In the final stage, this cellular toxicity leads to diabetes, most often diagnosed on the rise in capillary or venous blood sugar levels after transplantation. This diabetes often requires hypoglycemic treatment with insulin or oral anti-diabetic drugs. for a variable period. The pro-diabetogenic effect of tacrolimus is sometimes irreversible, justifying preventive treatment.
No clinical studies have looked at "sub-clinical" changes in insulin secretion or insulin resistance under tacrolimus prior to the onset of diabetes. The static indices HOMA-β% and HOMA-IR (Homeostasis Model Accessment of insulin resistance) make it possible to estimate insulin secretion and insulin resistance in fasting patients respectively, while the oral glucose disposition index (IDO) makes it possible to study insulin secretion and action dynamically (after a 75 g glucose load), and are calculated as follows:
HOMA IR= Fasting blood glucose (mmol/L) x Fasting insulin (mU/L)/ 22.5 HOMAβ% = 20 x fasting insulinemia (mU/L) / fasting plasma glucose (mmol/L) - 3.5 IDO = (delta insulinemia T30-T0/ delta blood glucose T30-T0)/insulinemia T0
These indices have already been studied in dialysis patients (diabetic and non-diabetic) and may allow a more detailed study of pancreatic response and insulin resistance under tacrolimus in patients prior to renal transplantation. Determining the "pancreatic response" to tacrolimus in patients prior to transplantation would prevent diabetes by adapting immunosuppressive treatment and post-transplant screening modalities in the event of pre-transplant subclinical abnormalities identified in our study. The development of tacrolimus-induced diabetes in pre-transplantation in our study will be a contraindication to tacrolimus at the time of transplantation and ciclosporin therapy will be preferred.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tacrolimus treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Intervention Description
Tacrolimus will be initiated at 0.1 mg/kg/day in two separate 12-hour oral doses (capsules) for 14 days.
Primary Outcome Measure Information:
Title
Proportion of haemodialysis patients modifying their glycemic profile receiving Tacrolimus
Time Frame
During 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Patient eligible for kidney transplantation at the Nantes University Hospital
Hemodialysis patient in one of the participating centres
Patient who is able to understand the proposed protocol and has given free and informed consent
Patient with affiliation to the French social security system.
Exclusion Criteria:
Personal history of diabetes treated or untreated
Temporary contraindication for carcinological reasons
Immunosuppressive treatment in the 6 months prior to inclusion
Macrolide Allergies
Hypersensitivity to the excipients used in the composition of tacrolimus
Intolerance to the HGPO test
Progressive infectious outbreak
Hepatic insufficiency
Intercurrent infectious pathology
Patient under guardianship, curatorship, legal protection measure, or deprived of liberty
Pregnant women, breastfeeding, or non-menopausal woman who refuses contraception
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chloé MOREAU
Phone
0251446572
Email
chloe.moreau@chd-vendee.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Awena LE FUR
Organizational Affiliation
CHD Vendée
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Départemental Vendée
City
La Roche-sur-Yon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Awena LE FUR
Facility Name
Centre Hospitalier Universitaire Nantes
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques DANTAL
12. IPD Sharing Statement
Learn more about this trial
Glucose Disorders Induced by Tacrolimus on Pre Transplantation Endstage Renal Disease Patients
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