Kidney Transplantation
Conditions
Keywords
Transplantation, kidney, delayed graft function, induction therapy, personalized medicine, First kidney transplantation, No anti HLA immunization prior transplantation, Risk of DGF higher than 40% calculated byt he score DGFS
Brief summary
The primary objective of the following randomized open label trial is to demonstrate how low immunological risk patients (no anti HLA immunization and first kidney transplantation) but diagnosed at high-risk of delayed graft function (assessed by DGFS score) could benefit from induction with ATG for preventing delayed graft function compared to Basiliximab.
Interventions
DRUGAnti-Thymocyte Globulins treatment
DRUGBasiliximab treatment
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults * First kidney transplantation * No anti HLA immunization prior transplantation * A risk of DGF higher than 40% calculated by the score DGFS (DGFS \>= 0.4) * Written informed consent
Exclusion criteria
* Previous or combined other transplantations * Non heart beating donors * Living donors * Pre-emptive transplantation * Patients on peritoneal dialysis * Leucopenia lower than 3000/mm3 * Thrombopenia lower than 100 000/mm3 * Donor EBV positive / recipient EBV Negative * Pregnant or lactating women * Patients under guardianship * Previous and current history of cancer and/or lymphoma * Current history of HCV or HBV or HIV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of a delayed graft function | 7 days | Occurrence of a delayed graft function defined as the need for dialysis within the first seven days post transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of estimated glomerular filtration rate (eGFR) | 15 days | Evolution of eGFR from day 1 to day 7 post transplantation then every two days until hospital discharge. Only eGFR assessments at least 48 hours after the last day of dialysis will be considered. |
| Number of dialysis procedures performed after transplantation without taking into account the dialysis due to hyperkaliemia and/or hyperhydratation | 3 months | — |
| Evolution of Tacrolimus levels (T0) from Day 1 to Day 7 post transplantation then every 2 days until hospital discharge. | 15 days | — |
| Duration of the delayed graft function | 7 days | Duration of the DGF defined by the number of days after the transplantation to reach an estimated glomerular filtration rate (eGFR) above 10 mL/min. Only eGFR assessments at least 48 hours after the last day of dialysis will be considered. |
| Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR | 3 months | — |
| Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation. | 3 months | — |
| Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation | 3 months | Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation will be evaluated by computerized quantification. |
| Hematologic effect within the first 3 months of surgery (WBC monitoring, CD3, CD4, CD8, CD19, NK and platelet sub population analysis). | 3 months | — |
Countries
France
Outcome results
None listed