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Completed

NCT Number: NCT03794492

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

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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Key information

Conditions

Kidney Transplant

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ajou University Hospital

Suwan, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Mycophenolate mofetil 500mg Tab. or 250mg Cap.

Drug
  • Orally, up to 1g BID(total 2g daily)

Other names: Myrept® Cap./Tab.

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

Methylprednisolone/prednisolone

Drug
  • Methyprednisolone 500mg / Prednisolone 5mg

Basiliximab

Drug
  • IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant)

Primary outcomes

  1. DSA(Donor-specific Anti-HLA Antibody)

    Time frame: 36 months

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

Secondary outcomes

  1. Incidence of composite efficacy failure

    Time frame: 12, 24, 36months

    The frequency and percentage of composite efficacy failure (Treated-BPAMR & ACR, graft loss, death and follow-up loss)

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

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)

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jan 7, 2019
Registry last updated
May 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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