Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome

Chong Kun Dang

Status and phase: Completed; Phase 4

Conditions: Kidney Transplant

Treatments: Drug: Mycophenolate mofetil 500mg Tab. or 250mg Cap.; Drug: Methylprednisolone/prednisolone; Drug: Basiliximab; Drug: Tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT03794492

223KT17017

Details and patient eligibility

About

Efficacy and Safety of My-Rept® (Mycophenolate Mofetil 500mg/Tab. or 250mg/Cap.) in Combination with Tacrolimus, Methylprednisolone, Simulect in Kidney Transplant Patients

Full 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 Tacrolimus, Mycophenolate mofetil, and corticosteroid

Enrollment: 169 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Over 19 years old(male or female)
2. Patients who are planning to receive a kidney from a deceased or a living unrelated/related donor
3. Agreement with written informed consent

Exclusion criteria

1. Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0

2. Patients with high sensitization who need desensitization therapy

3. Multi organ recipients or previous transplant with any organs

4. Diagnosed with cancer within five years

5. Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match positive donor

6. Patients who have positive HIV, HBsAg or Anti-HCV test result

7. 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

8. Pregnant or lactating women

9. In investigator's judgment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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169 participants in 1 patient group

Mycophenolate mofetil

Experimental group

Description:

One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.

Treatment:

Drug: Basiliximab

Drug: Methylprednisolone/prednisolone

Drug: Mycophenolate mofetil 500mg Tab. or 250mg Cap.

Drug: Tacrolimus