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Open-label, Multi-center, Single Arm, Phase 4 Trial (DoSAKOM)

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ClinicalTrials.gov Identifier: NCT03794492
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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

Condition or disease Intervention/treatment Phase
Kidney Transplant Patients Drug: Mycophenolate Mofetil 500Mg Tab. or 250Mg Cap. Drug: Tacrolimus Drug: Methylprednisolone/prednisone Drug: Simulect® (Basiliximab) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : March 31, 2018
Estimated Primary Completion Date : March 21, 2022
Estimated Study Completion Date : August 9, 2022


Arm Intervention/treatment
Experimental: Mycophenolate Mofetil 500Mg Tab. or 250Mg Cap.
Mycophenolate Mofetil 500Mg Tab. or 250Mg Cap.
Drug: Mycophenolate Mofetil 500Mg Tab. or 250Mg Cap.
Mycophenolate mofetil 1,000 ~ 2,000mg
Other Name: Mycophenolate mofetil 1,000 ~ 2,000mg

Drug: Tacrolimus
Tacrolimus

Drug: Methylprednisolone/prednisone
Methylprednisolone/prednisone

Drug: Simulect® (Basiliximab)
Simulect® (Basiliximab)




Primary Outcome Measures :
  1. DSA(Donor-specific Anti-HLA Antibody) [ Time Frame: 36 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Over 20 years old(male or female)
  2. Patients who are planning to receive a kidney from a deceased or a living non-related/related donor
  3. Agreement with written informed consent

Exclusion Criteria:

  1. Patient who receive a kidney from a related donor who showed HLA-0 mismatch (identical)
  2. Undergo desensitization therapy with high sensitization
  3. Patient with dual kidney transplantation recipient or have history of other organ transplantation in past or current.
  4. Patient who receive extra-renal solid organ or bone marrow stem cell transplantation.
  5. Patient who receive kidney transplantation from non-heart beating cadaveric donor(organ donor after cardiac death
  6. Patient who receive kidney transplantation from ABO blood type mismatching donor or lymphocyte cross matching (LCM) positive donor.
  7. Patient with cancer within 5 years, except cured skin cancer patient(Squamous cell or basal cell carcinoma or Early stage Renal cell carcinoma or Thyroid Cancer)
  8. Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor.
  9. Defined by the following laboratory parameters before screening period

    • Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT, ALP)is over 3 times than upper normal limit
    • ANC < 1,500/mm^3, or WBC < 2,500/mm^3, or Platelet < 50,000/mm^3
  10. Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs (ex, mycophenolate acid or tacrolimus, etc.) or additives.
  11. Administration of other Investigational drugs and/or immunosuppressants within 30days before screening period (except allowed immunosuppressants in protocol)
  12. Women in pregnant or breast-feeding or don't using adequate contraception.
  13. Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.
  14. In investigator's judgment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794492


Contacts
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Contact: Chang-Kwan Oh, Ph.D +82-31-219-5755 ohck@ajou.ac.kr

Locations
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Korea, Republic of
Ajou University Hospital Recruiting
Suwan, Korea, Republic of
Contact: Chang-Kwan Oh, Ph.D    +82-31-219-5755    ohck@ajou.ac.kr   
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Study Chair: Chang-Kwan Oh, Ph.D Ajou University School of Medicine

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03794492     History of Changes
Other Study ID Numbers: 223KT17017
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prednisone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Tacrolimus
Basiliximab
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antiemetics
Autonomic Agents