Status:
COMPLETED
Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Kidney Transplant
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients
Detailed Description
This study is a multi-center, non-comparative and phase IV clinical trial that evaluates incidence of Donor-Specific Antibody for 36 months after kidney transplantation when administered with Tacrolim...
Eligibility Criteria
Inclusion
- Over 19 years old(male or female)
- Patients who are planning to receive a kidney from a deceased or a living unrelated/related donor
- Agreement with written informed consent
Exclusion
- Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0
- Patients with high sensitization who need desensitization therapy
- Multi organ recipients or previous transplant with any organs
- Diagnosed with cancer within five years
- Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match positive donor
- Patients who have positive HIV, HBsAg or Anti-HCV test result
- At screening
- Under treatment for active liver disease, or Over 3times upper than normal range of liver function test (T-bilirubin, AST, ALT)
- WBC\<2,500/mm3, PLT \<50,000/mm3, ANC\<1,500/mm3
- Pregnant or lactating women
- In investigator's judgment
Key Trial Info
Start Date :
March 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT03794492
Start Date
March 31 2018
End Date
April 27 2023
Last Update
May 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ajou University Hospital
Suwan, South Korea