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

NCT05282875 | Unknown

• 1 other identifier: 2021PI192
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

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).

Conditions

Kidney Transplantation; Immunosuppressive Agents; HLA Sensitization; Dialysis

Keywords

immunosuppressive agents; graft loss; HLA antibodies; retransplantation; kidney transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patients survival

  baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020

• New transplantation

  baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020

• Graft Survival after retransplantation

  baseline = return in dialysis, end of follow up = death or last follow-up or 31 december 2020

• Incidence of infectious, neoplastic and cardiovascular events

  baseline = return in dialysis, end of follow up = 1 year after return in dialysis

Study Arms (1)

kidney transplant patients returning to dialysis after graft loss

This cohort contains kidney transplant patients returning to dialysis after graft loss in Lorraine between 1 January 2007 and 31 December 2019. They are identified by the REIN registry of the Lorraine region. The REIN registry is a national database that contains multiple information on patients with chronic end-stage renal disease (type of nephropathy, type of replacement therapy, comorbidities).

Drug: management of immunosuppressive therapy

Interventions

management of immunosuppressive therapy DRUG

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

kidney transplant patients returning to dialysis after graft loss

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Central HNF

Nancy, Lorraine, 54000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 16, 2022
• Study Start: February 1, 2022
• Primary Completion: March 30, 2022
• Study Completion: September 1, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)