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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03794492

Enrollment

169

Registered

2019-01-07

Start date

2018-03-31

Completion date

2023-04-27

Last updated

2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant

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

Interventions

DRUGMycophenolate mofetil 500mg Tab. or 250mg Cap.

\- Orally, up to 1g BID(total 2g daily)

DRUGTacrolimus

\- Orally, check the blood ceocentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3-8ng/ml

DRUGMethylprednisolone/prednisolone

\- Methyprednisolone 500mg / Prednisolone 5mg

DRUGBasiliximab

\- IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
DSA(Donor-specific Anti-HLA Antibody)	36 months	Incidence of DSA(Donor-specific Anti-HLA Antibody) up to 36months after Kidney transplantation

Secondary

Measure	Time frame	Description
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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026