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TACITE : Impact of maintaining tacrolimus after renal transplant failure on access to a retransplantation, a randomized controlled trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523386-26-00
Enrollment
200
Registered
2026-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal transplant failure

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

University Hospital Of Clermont-Ferrand
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 24, 2026