Metabolic and Infectious Complications Post Belatacept Conversion

• Conditions: Cardiovascular Diseases; Immunosuppression; Kidney Transplant; Complications; Kidney Transplant Infection
• Interventions: Diagnostic Test: Oral glucose tolerance test

• Registration Number: NCT05316038
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The BELASWITCH study is a prospective single-centre study including all kidney transplant patients for whom a conversion from Tacrolimus to Belatacept has been decided by the transplant clinicians of the Grenoble Alpes University Hospital.

Each patient will be included at the time of conversion (patients stable on Tacrolimus for at least 6 months) and will be their own control 1 year after conversion to Belatacept.

The study has two components:

* A "Metabolic" benefit arm: the investigators assume that conversion from Tacrolimus to Belatacept reduces the risk of diabetes by reducing the level of insulin resistance.

* An "Infectious" risk arm: measurement of the viral load of Torque Teno Virus to assess the state of immunosuppression of patients. In this sense, the investigators hypothesise that it could serve as a biomarker of immunodepression in this population.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07
• Study Start: 2022-06-01
• Primary Completion: 2023-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adult patients who have had a kidney transplant more than 6 months ago.
• Whose immunosuppression includes stable Tacrolimus (change in dose or dosage form allowed) for at least 3 months.
• Therapeutic plan to change Tacrolimus-based immunosuppression to Belatacept
• Having signed the consent of collection CRB04 - Nephrology Collection (last authorization number: AC-2019-3627) and the BELASWITCH protocol consent.

Exclusion Criteria

• Subjects under guardianship or deprived of liberty
• Patients who object to the use of their data and/or samples in the research
• Patients having received an immunosuppressive treatment different from the standard one (Tacrolimus, mycophenolate mofetil or Everolimus, corticosteroids)
• ABO and/or HLA incompatible kidney transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Belatacept cohort	Oral glucose tolerance test	Kidney transplanted patients for whom a conversion from Tacrolimus to belatacept has been decided will be included in this cohort.

Primary Outcome Measures

Name	Time	Method
Oral glucose tolerance test results in kidney transplant patients on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 1 year	1 year
Torque TenoVirus replication (in copies/ml) in kidney transplant patients on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year.	1 year

Secondary Outcome Measures

Name	Time	Method
Comparison of HDL measurment in g/l on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year	1 year
Compare the performance of TorqueTenoVirus quantitative polymerase chain reaction in copies/ml performed on plasma and whole blood samples	3 months
Comparison of weight and height (combined to report BMI in kg/m^2) on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year	1 year
Comparison of LDL measurment in g/l on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year	1 year
Number of major cardiovascular events (stroke, coronary syndrome, hospitalization for cardiac decompensation, death from cardiovascular causes)	1 year
Correlatation of TorqueTenoVirus replication (in copies/ml) with immunosuppressant assays: Tacrolimus (µg/l) at M-1 and D0 and Belatacept (µg/l) at M3, M6 and M12	1 year
Trough Plasma Concentration of Belatacept	3 months
Comparison of HbA1c measurment in percentage on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year	1 year
Comparison of triglycerides measurment in g/l on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year	1 year
Correlation of TorqueTenoVirus replication in copies/ml with the occurrence of opportunistic infections (Cytomegalovirus, Epstein-Barr virus, BKVirus).	1 year	Opportunistic infections are defined as positive DNAemia in copies/ml
Correlation of TorqueTenoVirus in copies/ml and the risk of biopsy-proven renal transplant rejection up to M12 after conversion to Belatacept.	1 year	Rejection are defined according to the more recent histological Banff classification
Area under the plasma concentration versus time curve (AUC) of Belatacept	3 months
Comparison of abdominal perimeter of kidney transplant recipients in centimeters on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year	1 year
Comparison of blood pressure in mmHg on Tacrolimus (M-1 and D0) and after conversion to Belatacept at 3 months, 6 months and 1 year	1 year