renal transplant failure
Conditions
Brief summary
In France, the cPRA is evaluated by the French Agency of Biomedicine and « called incompatible graft rate » (TGI), defined by a calculated panel reactive antibody (cPRA) level ≥ 85% at 1 year (treated as binary outcome cPRA ≥ 85% yes/no). This rate was automatically calculated for each patient on the waiting list each 3 months. en français
Detailed description
Access to transplantation - Rate of hyperimmunized patients on the waiting list for a second kidney transplant during the follow up period at 1 and 3 years., Influence between cPRA rate at KTF date and immunosuppression maintenance on the transplant access - cPRA rate HLA difference between KTF date (Day 0) and 1 year followed by 3 years (to assess long term humoral memory response)., Rate of transplantation for both groups at 1 and 3 years., Time on dialysis calculated as the period between the date of start of dialysis after KTF and date of the second kidney transplantation., Waiting time calculated as the period between the relisting date and the date of the second kidney transplantation., Quality of the 2nd Allograft - Preformed DSA at retransplantation (yes vs. no)., Graft of standard or expanded criteria donor or living donor., Type of induction (thymoglobulin vs basiliximab vs no induction)., Interim between the both transplantations - Allograft nephrectomy: yes / no, date and etiology., Adverse events: Serious infection exposure-adjusted rates (hospitalization or opportunistic); Neoplasia exposure-adjusted rates (total and non-cutaneous neoplasia); Major cardiovascular exposure-adjusted rates; Survival at 1 and 3 years., Health-Economics Analyses: to produce cost-utility and cost-effectiveness analyses (CUA and CEA, respectively) to determine the efficiency of maintenance tacrolimus in comparison to Treatment
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In France, the cPRA is evaluated by the French Agency of Biomedicine and « called incompatible graft rate » (TGI), defined by a calculated panel reactive antibody (cPRA) level ≥ 85% at 1 year (treated as binary outcome cPRA ≥ 85% yes/no). This rate was automatically calculated for each patient on the waiting list each 3 months. en français | — |
Secondary
| Measure | Time frame |
|---|---|
| Access to transplantation - Rate of hyperimmunized patients on the waiting list for a second kidney transplant during the follow up period at 1 and 3 years., Influence between cPRA rate at KTF date and immunosuppression maintenance on the transplant access - cPRA rate HLA difference between KTF date (Day 0) and 1 year followed by 3 years (to assess long term humoral memory response)., Rate of transplantation for both groups at 1 and 3 years., Time on dialysis calculated as the period between the date of start of dialysis after KTF and date of the second kidney transplantation., Waiting time calculated as the period between the relisting date and the date of the second kidney transplantation., Quality of the 2nd Allograft - Preformed DSA at retransplantation (yes vs. no)., Graft of standard or expanded criteria donor or living donor., Type of induction (thymoglobulin vs basiliximab vs no induction)., Interim between the both transplantations - Allograft nephrectomy: yes / no, date and | — |