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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||158 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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: Simulect® (Basiliximab)
- DSA(Donor-specific Anti-HLA Antibody) [ Time Frame: 36 months ]
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
|Contact: Chang-Kwan Oh, Ph.Demail@example.com|
|Korea, Republic of|
|Ajou University Hospital||Recruiting|
|Suwan, Korea, Republic of|
|Contact: Chang-Kwan Oh, Ph.D +82-31-219-5755 firstname.lastname@example.org|
|Study Chair:||Chang-Kwan Oh, Ph.D||Ajou University School of Medicine|