Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04444843
Study type Interventional
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Wujun Xue, Prof.
Phone +86 13991990128
Email xwujun163@mail.xjtu.edu.cn
Status Recruiting
Phase Phase 4
Start date January 22, 2021
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT01336296 - Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients Phase 4
Recruiting NCT01150487 - Paired Marrow Aspirations to Assess Assays in Sensitized Renal Allograft Recipients N/A
Recruiting NCT05938712 - The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients Phase 2
Completed NCT00217100 - A Multivitamin Comparison Study in Kidney Transplant Recipients. Phase 3
Active, not recruiting NCT00199667 - Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients Phase 4
Terminated NCT01517984 - Immune Monitoring and CNI Withdrawal in Low Risk Recipients of Kidney Transplantation Phase 2
Recruiting NCT04642833 - Prostate Cancer in Renal Transplants Recipients
Not yet recruiting NCT05293704 - An Open Study on the Preventive Effect of Early Mizoribine Conversion on BKV Nephropathy in Renal Transplant Recipients Phase 4
Completed NCT02555566 - Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy - The TRANSPLANT-EETs Study N/A
Completed NCT01782586 - Validation of Gene Expression Markers of Renal Allograft Functional Decline
Enrolling by invitation NCT02042963 - KoreaN Cohort Study for Outcome in Patients With Kidney Transplantation (KNOW-KT) N/A
Not yet recruiting NCT05702398 - Pilot Trial of Supplemental Vitamin A and Nicotinamide Early Phase 1
Active, not recruiting NCT05425498 - The Effects of Physical Activity Behavior Change in Kidney Transplant Recipients N/A
Completed NCT01889758 - Pharmacokinetic Studies of Tacrolimus in Transplant Patients Phase 4
Terminated NCT02268201 - A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule Phase 4
Active, not recruiting NCT03979365 - Envarsus XR Compared to Immediate Release Tacrolimus Phase 4
Recruiting NCT04965935 - Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients Phase 3
Completed NCT02392312 - Observational Study to Evaluate the Safety and Efficacy of ATG-F on Kidney Transplant Recipients
Completed NCT02639949 - Measuring and Improving Medication Adherence in Kidney Transplant Patients N/A
Withdrawn NCT02058875 - Cardiovascular Risk Following Conversion to Full Dose Myfortic® and Neoral® Two-hour Post Level Monitoring Phase 4