NCT04444843

Risk Factors of Chinese Kidney Transplant Recipients DSA Based on MPA Immunosuppressive Regimen

A Multicenter Clinical Trial: Risk Factors of Chinese Kidney Transplant Recipients DSA Based on MPA Immunosuppressive Regimen

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

THE INCIDENCE AND INFLUENTIAL FACTORS OF DSA IN CHINESE RENAL TRANSPLANT RECIPIENTS WITH MPA-BASED IMMUNOSUPPRESSIVE REGIMEN： A MULTI-CENTER CLINICAL STUDY (TIAIFOD STUDY) Study procedure Investigators at participating centers will identify patients fulfilling inclusion criteria and do not violate any exclusion criteria. Informed consent will be obtained upon entry into the study according to national regulations. Patients will be enrolled into the study and clinical data of patient history will be collected. Clinical data will be collected prospectively up to a total period of 12 months.

Detailed description

Medical history and Kidney transplantation This will include age at transplantation, gender, race, weight, height of both recipient and donor; Recipients: previous history ,BMI ,primary kidney disease including biopsy proven diagnosis (if present), historic dialysis，pregnancy history (female). Donor: the catalogue (DCD,DBD,DBCD), ECD or not，the cause of death, received CPR or not; zero biopsy results if done, ABO blood type match, HLA-MM, cold and warm ischemic time. Clinical data at baseline and 12months follow up period: Clinical assessments, laboratory, comorbidity, immunosuppressive therapy, and selected concomitant therapy (anti-hypertension anti-hyperlipidemics, anti-diabetics and drugs known to affect renal function) will be collected at transplant day（Day 0, visit 0）and 8 subsequent visits scheduled Day 3, Week1, Week2, Week 4，Week 12，Week 26，Week 40，Week 52 post transplantation. MPA-AUC, acute rejection episodes and graft loss will be collected at visits scheduled Day 3, Week 1，Week 2, Week 4，Week 12， Week 26(6 month)，Week 40，Week 52 (12 month) post transplantation. On day 3, MPA-AUC will be tested by full time sample (0h,0.5h,1h,2h,3h,4h,6h,8h,10h,12h post receiving MMF). LSS (0h, 0.5h, 2h post receiving MMF) will be used for testing MPA-AUC on other visits. PRA will be tested on week 4, week 12, week 26, week 52. If PRA is positive, DSA will be tested following once. All the PRA and DSA MFI and phenotype will be collected（including the clinical-drive test）. Statistical analysis: The primary endpoint in this study is the incidence of DSA formation in 12-months post-transplantation in Chinese kidney transplant recipients with MMF-based IS regimen. The proportion and its 95% CI will be provided. The influential factors of DSA formation will be estimated using logistic regression including relevant influential factors, where the influential factors are defined as {age, gender of donor / recipients recipient: BMI, blood transfusion, previous AR （before DSA appears）, ECD , cold ischemia time, HLA-MM, Tac trough concentration, MPA-AUC, DGF, introduction therapy (including use or not and the drugs )}. . The full MPA-AUC0-12h will be calculated using the trapezoidal rule. The calculated formula with Limited Sample Strategy (LSS) will be established to predict the MPA-AUC0-12h in the Chinese patients. Correlation coefficients will be calculated and multiple stepwise regression analysis will be used to determine the time points and best equation for evaluating MPA-AUC0-12h. Estimates for the time-to-event variable(s), such as Overall Survival(OS), will be obtained by using the Kaplan-Meier (KM) approach together with associated 95% CI. The other secondary endpoints will be summarized descriptively depended on the variable type. The comparison between patients with and without DSA-positive will be performed according to the variable type.

Conditions

• Kidney Transplant Recipients

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil Capsules	Patients who received MMF+TAC+ Corticosteroids immunosuppressive regimen as first choice post transplantation

Timeline

• Start date: 2021-01-22
• Primary completion: 2022-12-21
• Completion: 2023-12-31
• First posted: 2020-06-24
• Last updated: 2022-05-27

Locations

1 site across 1 country: China