Belaswitch: Metabolic and Infectious Complications Post Belatacept Conversion
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Belatacept cohort Kidney transplanted patients for whom a conversion from Tacrolimus to belatacept has been decided will be included in this cohort. |
Diagnostic Test: Oral glucose tolerance test
The test is performed on an empty stomach for at least 10 hours. The first blood sugar level is taken on an empty stomach. Then ingestion of 75g of sugar. A second blood test takes place 1 hour after the sugar intake and the third blood sugar test takes place 2 hours after the sugar intake.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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]
- 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 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 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]
- 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]
- 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]
- Number of major cardiovascular events (stroke, coronary syndrome, hospitalization for cardiac decompensation, death from cardiovascular causes) [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
- 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]
- 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
- Compare the performance of TorqueTenoVirus quantitative polymerase chain reaction in copies/ml performed on plasma and whole blood samples [3 months]
- Trough Plasma Concentration of Belatacept [3 months]
- Area under the plasma concentration versus time curve (AUC) of Belatacept [3 months]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Grenoble
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Belaswitch_Grenoble