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

NCT03794492 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2024-05-22

No results posted yet for this study

Summary

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

Conditions

  • Kidney Transplant

Interventions

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)

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Chang-Kwan Oh, Ph.D · Ajou University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-31
Primary Completion
2022-07-22
Completion
2023-04-27

Countries

  • South Korea

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03794492 on ClinicalTrials.gov