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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Transplant
• Intervention / Treatment: Drug: Mycophenolate mofetil 500mg Tab. or 250mg Cap.; Drug: Tacrolimus; Drug: Methylprednisolone/prednisolone; Drug: Basiliximab

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

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwan, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Drug: Mycophenolate mofetil 500mg Tab. or 250mg Cap.; - Orally, up to 1g BID(total 2g daily); Other Names: Myrept® Cap./Tab.; 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of composite efficacy failure	The frequency and percentage of composite efficacy failure (Treated-BPAMR & ACR, graft loss, death and follow-up loss)	12, 24, 36months

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Study Chair: Chang-Kwan Oh, Ph.D, Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2018
• Primary Completion (Anticipated): August 11, 2022
• Study Completion (Anticipated): December 29, 2022

Study Registration Dates

• First Submitted: January 3, 2019
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 7, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Calcineurin Inhibitors; Prednisolone; Methylprednisolone; Tacrolimus; Mycophenolic Acid; Basiliximab
• Other Study ID Numbers: 223KT17017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No