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Anti-HLA Immunization And Immunosuppressive Therapy Management In Kidney Transplant Patients Returning to Dialysis

NCT05282875 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 430

Last updated 2022-04-05

No results posted yet for this study

Summary

This study is an analytical observational retrospective cohort study. It is a single-center study conducted in the Nancy University Hospital.

End stage renal disease is the ultimate stage of the chronic kidney disease. Patients need extra-renal replacement techniques. Kidney transplantation is the most effective option for survival, quality of life and costs.

Then long-term immunosuppressive agents are required to prevent allograft rejection and improve graft survival.

The number of patients who return in dialysis after graft loss is increasing and accounts for 10% of incident dialysis patients and 14% of patients on the kidney transplant waiting list registered in 2019. This population may develop complications induced by end-stage renal disease and adverse events related to prolonged exposure to immunosuppressive agents.

There are currently no formal guidelines on the management of immunosuppressive agents when patients return to dialysis. Reduction or discontinuation of therapy appears to decrease cardiovascular, infectious, and neoplastic complications. However, continuing these treatments may limit anti-HLA sensitization which may access to retransplantation.

Only a few low-powered cohort studies have evaluated the impact of the management of immunosuppressive therapy on the HLA-sensitization.

The hypothesis of our study is that the continuation of immunosuppressive agents when patients return in dialysis may limit anti-HLA sensitization. Therefore, access to retransplantation could be facilitated.

The main objective is to compare the evolution of anti-HLA sensitization according to the management of immunosuppressive treatment after the return in dialysis (maintenance, reduction, cessation).

Secondary objectives are time to re-transplantation for patients on the transplant waiting list, survival of the new graft, patient survival, and dialysis complications (cardiovascular, infectious and neoplastic complications).

Conditions

  • Kidney Transplantation
  • Immunosuppressive Agents
  • HLA Sensitization
  • Dialysis

Interventions

DRUG

management of immunosuppressive therapy

3 groups : * Discontinuation of immunosuppressive agents * Reduction of immunosuppressive agents * Maintenance of immunosuppressive agents

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-03-30
Completion
2022-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282875 on ClinicalTrials.gov