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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03794492
Other study ID # 223KT17017
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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