Kidney Transplantation, Kidney Transplant Rejection
Conditions
Keywords
kidney transplantation, soluble B lymphocyte activating factor, antibody-mediated rejection, a proliferation-inducing ligand
Brief summary
Antibody-mediated rejection (AMR) is a significant risk factor for graft loss in kidney transplantation. Soluble B cell-activating factor (sBAFF) and a proliferation-inducing ligand (APRIL) plays a critical role in the activation and differentiation of B cells, making it a potential predictive biomarker for AMR. In this prospective multicenter cohort study, the effectiveness of sBAFF/APRIL in predicting AMR after kidney transplantation is evaluated. Recipient sBAFF/APRIL levels are monitored before transplantation, and at seven days, two weeks, one month, three months, and every three months after transplantation continuously . The primary outcome is the occurrence of AMR, while the status of donor-specific antibodies (DSA), T cell-mediated rejection (TCMR), and other clinical parameters are secondary outcomes. The predictive capacity of sBAFF/APRIL for both the primary and secondary outcomes will be investigated.
Interventions
None listed
Sponsors
Fifth Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial People's Hospital
Nanfang Hospital, Southern Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Second Affiliated Hospital of Guangzhou Medical University
The Shenzhen's People's Hospital
Shenzhen Third People's Hospital
Zhujiang Hospital
First Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Living donor or deceased donor kidney recipients. 2. Patient is willing and capable of giving written informed consent for participation and able to participate in the study for 24 months.
Exclusion criteria
1. Preoperative donor specific antibody positive . 2. Combined or multi-organ transplantation. 3. Poor compliance. 4. Unable to continue the follow-up. 5. Patients who are judged by the doctors to be excluded for this trial (Details need to be provided).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Antibody-mediated Rejection | 24 months | Antibody-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated glomerular filtration rate (eGFR) | 24 months | eGFR is calculated based on Modification of Diet in Renal Disease (MDRD) formula, at one week, two weeks, one month, 3 months and every 3 months later, after kidney transplantation. |
| Incidence of de novo donor-specific antibody | 24 months | Donor-specific antibody is monitored before transplantation and every six months after transplantation. |
| Incidence of T cell-mediated rejection | 24 months | T cell-mediated rejection is diagnosed based on kidney biopsy according to Banff 2019 criteria |
| Incidence of infection | 24 months | — |
| Renal graft survival | 24 months | Graft loss is defined as return to dialysis, removal of renal graft or kidney re-transplantation. |
| Death-censored renal graft survival | 24 months | Death-censored renal graft survival is defined as graft survival censored for death with a functioning graft |
| Patient survival | 24 months | — |
| Qualitative or Quantitative meassurement of urine protein | 24 months | Urine protein test result is collected at one week, two weeks, one month, 3 months and every 3 months later, after kidney transplantation. |
Countries
China
Contacts
Primary ContactChangxi Wang, M.D., Ph.D.
Backup ContactHuanxi Zhang, M.D, Ph.D.
Outcome results
None listed