Study of Eplets Matching in Kidney Transplantation

NCT03818698 | Unknown

• 1 other identifier: XJTU1AF-CRF-2018-026
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The rapid changes of tissue-typing technology, including the widely used of highly specific molecular typing methods and solid phase analysis technology for detection of alleles specific anti-HLA antibodies, promoted the selection of organ transplant recipients to a more accurate level and promoted the scientific development of organ transplant matching. At present, the graft survival rate has been greatly improved through the prevention and treatment of T-cell-mediated rejection (TCMR), but the humoral immune response, the main cause of late graft loss, is still not effectively controlled. HLA eplets matching is based on the principle that if a donor HLA antigen shares a specific epitope with a recipient's HLA antigen, that eplets will not be recognized as foreign and will therefore not provoke a humoral immune response. The selection of transplant recipients based on this principle can avoid antibody-mediated rejection (AMR), reduce sensitization after transplantation, and select the most appropriate organs to avoid pre-existing antibodies in the case of persisting HLA antibody positive recipients choosing. In this study, the HLA high-resolution typing data of kidney transplant recipients from 2014 to the end of 2017 were analyzed with HLA Matchmaker for eplets mismatching number. To analyze the incidence of dnDSA and AMR after kidney transplant recipients with different eplets mismatching number posttransplant, and to elucidate the important role of tissue configuration patterns based on HLA eplets matching in long-term graft survival.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• The occurrence of dnDSA and AMR

  The chi-square test analyzed the relationship between the Eplets mismatching numbers and the generation of dnDSA, as well as the differences in the Eplets mismatching numbers between the DSA positive group and the DSA negative group, and the differences in Eplets mismatching numbers between the AMR group and the non-AMR group. Kaplan-meier survival curve was used to analyze the differences in long-term graft survival among groups with different Eplets mismatching numbers. P\<0.05 was considered statistically significant.

  3 years

Interventions

Eplets mismatching numbers OTHER

In this study, the HLA high-resolution typing data of kidney transplant recipients from 2014 to the end of 2017 were analyzed with HLA Matchmaker for eplets mismatching number. To analyze the incidence of dnDSA and AMR after kidney transplant recipients with different eplets mismatching number posttransplant, and to elucidate the important role of tissue configuration patterns based on HLA eplets matching in long-term graft survival.

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients after kidney transplantation.

You may qualify if:

• Patients with normal or nearly normal renal function after transplantation
• Patients with abnormal renal function indicators after transplantation but in a stable state without loss of function (serum creatinine 176-265 mmol/l)
• Patients who are able to take immunosuppressive agents orally in strict accordance with the doctor's instructions and can be regularly reviewed

You may not qualify if:

• All patients with renal transplantation function damage caused by surgical factors, medicinal factors, acute tubular necrosis (ATN) and other factors
• Postoperative patients complicated with malignant tumors or infectious diseases such as tuberculosis and hepatitis

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The biospecimen in the study is sera of recipients after kidney transplantation.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: December 31, 2022
• Last Updated: May 27, 2022

Record last verified: 2021-08

Locations

CN (1)