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

Phase 4

Completed

• Conditions: Kidney Transplant
• Interventions: Drug: Mycophenolate mofetil 500mg Tab. or 250mg Cap.; Drug: Tacrolimus; Drug: Methylprednisolone/prednisolone; Drug: Basiliximab

• Registration Number: NCT03794492
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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 Tacrolimus, Mycophenolate mofetil, and corticosteroid

Study Timeline

• Study Start: 2018-03-31
• Study First Submitted: 2019-01-03
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-07
• Primary Completion: 2022-07-22
• Study Completion: 2023-04-27
• Status Verified: 2023-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mycophenolate mofetil	Mycophenolate mofetil 500mg Tab. or 250mg Cap.	One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.
Mycophenolate mofetil	Methylprednisolone/prednisolone	One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.
Mycophenolate mofetil	Tacrolimus	One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.
Mycophenolate mofetil	Basiliximab	One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.

Primary Outcome Measures

Name	Time	Method
DSA(Donor-specific Anti-HLA Antibody)	36 months	Incidence of DSA(Donor-specific Anti-HLA Antibody) up to 36months after Kidney transplantation

Secondary Outcome Measures

Name	Time	Method
Incidence of composite efficacy failure	12, 24, 36months	The frequency and percentage of composite efficacy failure (Treated-BPAMR \& ACR, graft loss, death and follow-up loss)

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwan, Korea, Republic of