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

Kidney Transplant Clinical Trial

Official title:

Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome: Open-label, Multi-center, Single Arm, Phase 4 Trial (DoSAKOM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794492
• Other study ID #: 223KT17017
• Status: Completed
• Phase: Phase 4
• Start date: March 31, 2018
• Est. completion date: April 27, 2023

Study information

• Verified date: May 2023
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: April 27, 2023
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• Mycophenolate mofetil 500mg Tab. or 250mg Cap.
- Orally, up to 1g BID(total 2g daily)
• Tacrolimus
- Orally, check the blood ceocentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3-8ng/ml
• Methylprednisolone/prednisolone
- Methyprednisolone 500mg / Prednisolone 5mg
• Basiliximab
- IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant)

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwan

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DSA(Donor-specific Anti-HLA Antibody)	Incidence of DSA(Donor-specific Anti-HLA Antibody) up to 36months after Kidney transplantation	36 months
Secondary	Incidence of composite efficacy failure	The frequency and percentage of composite efficacy failure (Treated-BPAMR & ACR, graft loss, death and follow-up loss)	12, 24, 36months