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

NCT03794492 | Completed Phase 4

• 1 other identifier: 223KT17017
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

• DSA(Donor-specific Anti-HLA Antibody)

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

  36 months

Secondary Outcomes (1)

• Incidence of composite efficacy failure

  12, 24, 36months

Study Arms (1)

Mycophenolate mofetil

EXPERIMENTAL

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

Drug: Mycophenolate mofetil 500mg Tab. or 250mg Cap.; Drug: Tacrolimus; Drug: Methylprednisolone/prednisolone; Drug: Basiliximab

Interventions

Mycophenolate mofetil 500mg Tab. or 250mg Cap. DRUG

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

Also known as: Myrept® Cap./Tab.

Mycophenolate mofetil

Tacrolimus 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

Mycophenolate mofetil

Methylprednisolone/prednisolone DRUG

\- Methyprednisolone 500mg / Prednisolone 5mg

Mycophenolate mofetil

Basiliximab DRUG

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

Mycophenolate mofetil

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 19 years old(male or female)
• Patients who are planning to receive a kidney from a deceased or a living unrelated/related donor
• Agreement with written informed consent

You may not qualify if:

• Donor's HLA antigen matches recipient or the Degree of Mis-Match is 0
• Patients with high sensitization who need desensitization therapy
• Multi organ recipients or previous transplant with any organs
• Diagnosed with cancer within five years
• Patient who receive kidney from ABO incompatibility donor or Lymphocyte cross-match positive donor
• Patients who have positive HIV, HBsAg or Anti-HCV test result
• 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
• Pregnant or lactating women
• In investigator's judgment

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Ajou University Hospital

Suwan, South Korea

Location

MeSH Terms

Interventions

Mycophenolic Acid; Tablets; Capsules; Tacrolimus; Methylprednisolone; Prednisolone; Basiliximab

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations; Macrolides; Lactones; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chang-Kwan Oh, Ph.D

  Ajou University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 7, 2019
• Study Start: March 31, 2018
• Primary Completion: July 22, 2022
• Study Completion: April 27, 2023
• Last Updated: May 22, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)