Kidney Transplantation Clinical Trial
Official title:
Evolution of Anti-HLA Immunization According to Immunosuppressive Therapy Management Modalities in Kidney Transplant Patients Returning to Dialysis in Lorraine Between January 2007 and December 2019
Verified date | March 2022 |
Source | Central Hospital, Nancy, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Active, not recruiting |
Enrollment | 430 |
Est. completion date | September 1, 2022 |
Est. primary completion date | March 30, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients included in the Lorraine regional REIN registry over the period 2007-2019, - Returning in dialysis after a kidney transplantation, with a living or deceased donor. - On haemodialysis or peritoneal dialysis. - Registered or not on the waiting-list for retransplantation Exclusion Criteria: - Patients with graft dysfunction receiving a pre-emptive retransplantation - Absence of serum tested for anti-HLA (human leukocyte antigen) antibodies after the return to dialysis. - No information on immunosuppressive agents |
Country | Name | City | State |
---|---|---|---|
France | Central HNF | Nancy | Lorraine |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the evolution of anti-human leucocyte antigen sensitization according to the management of immunosuppressive therapy | Evolution of the panel reactive antibody evolution 6 months after the return in dialysis | baseline = return in dialysis, t1=6 months after return in dialysis | |
Secondary | Patients survival | Patient survival after return in dialysis | baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020 | |
Secondary | New transplantation | Retransplantation after return in dialysis | baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020 | |
Secondary | Graft Survival after retransplantation | Graft Survival after retransplantation | baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020 | |
Secondary | Incidence of infectious, neoplastic and cardiovascular events | Incidence of infection, neoplastic and cardiovascular events after return in dialysis | baseline = return in dialysis, end of follow up = 1 year after return in dialysis |
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