Clinical trial NCT05282875: Anti-HLA Immunization And Immunosuppressive Therapy Management In Kidney Transplant Patients Returning to Dialysis
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplantation
Immunosuppressive Agents
HLA Sensitization
Dialysis
Keywords: immunosuppressive agents
graft loss
HLA antibodies
retransplantation
kidney transplantation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 430
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort of patients returning to dialysis after graft loss is extracted from the REIN Lorraine registry. Patients returning in dialysis after graft loss between 1st January 2007 and 31st December 2019 are included.

From this cohort, 3 groups were created according to the management of their immunosuppressive therapy : maintenance, reduction, and discontinuation. The immunological data of the patients are recovered from the HLA laboratory of the Nancy University Hospital.

Brief 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).

Detailed description: Cohort constitution :

The cohort of patients returning to dialysis after graft loss is extracted from the REIN (Réseau Epidémiologique et Information en Néphrologie) Lorraine registry, which follow all patients in end-stage renal failure under replacement therapy in the Lorraine region since 2001.

Patients returning to dialysis after graft loss between 1st January 2007 and 31st December 2019 are extracted from the register and included.

From this cohort, 3 groups were created according to the management of their immunosuppressive therapy : maintenance, reduction, and discontinuation. The immunological data of the patients are recovered from the HLA laboratory of the Nancy University Hospital.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the evolution of anti-human leucocyte antigen sensitization according to the management of immunosuppressive therapy
timeFrame: baseline = return in dialysis, t1=6 months after return in dialysis
Secondary outcomes:
measure: Patients survival
timeFrame: baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020
measure: New transplantation
timeFrame: baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020
measure: Graft Survival after retransplantation
timeFrame: baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020
measure: Incidence of infectious, neoplastic and cardiovascular events
timeFrame: baseline = return in dialysis, end of follow up = 1 year after return in dialysis
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central HNF
state: Lorraine
Study officials:
References: