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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-31

Study Completion Date

2023-04-27

Brief Summary

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

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Detailed Description

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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

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Kidney Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mycophenolate mofetil

One arm: Mycophenolate mofetil 500mg Tab. or 250mg Cap.

Group Type EXPERIMENTAL

Mycophenolate mofetil 500mg Tab. or 250mg Cap.

Intervention Type DRUG

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

Tacrolimus

Intervention Type DRUG

\- 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

Intervention Type DRUG

\- Methyprednisolone 500mg / Prednisolone 5mg

Basiliximab

Intervention Type DRUG

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

Interventions

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Mycophenolate mofetil 500mg Tab. or 250mg Cap.

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

Intervention Type 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

Intervention Type DRUG

Methylprednisolone/prednisolone

\- Methyprednisolone 500mg / Prednisolone 5mg

Intervention Type DRUG

Basiliximab

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

Intervention Type DRUG

Other Intervention Names

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Myrept® Cap./Tab.

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No