NCT03794492

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Kidney Transplant

Interventions

Type	Name	Description
DRUG	Mycophenolate mofetil 500mg Tab. or 250mg Cap.	\- Orally, up to 1g BID(total 2g daily)
DRUG	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
DRUG	Methylprednisolone/prednisolone	\- Methyprednisolone 500mg / Prednisolone 5mg
DRUG	Basiliximab	\- IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant)

Timeline

• Start date: 2018-03-31
• Primary completion: 2022-07-22
• Completion: 2023-04-27
• First posted: 2019-01-07
• Last updated: 2024-05-22

Locations

1 site across 1 country: South Korea