Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0653
Source ID: NCT05719376
Associated Drug: Monofer (Experimental)
Title: The Effect of Intravenous Iron Therapy and Erythropoiesis-stimulation Agent Combination on Renal Transplant Outcomes
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic
Interventions: DRUG: Monofer (experimental)|DRUG: control group
Outcome Measures: Primary: Comparison of the number of blood transfusions according to the combination of intravenous iron therapy and EPO agent on perioperative period, Comparison of the number of blood transfusions(packed RBC transfusion) according to the combination of intravenous iron therapy and EPO agent on perioperative period, From 1 month before operation to 1 year after operation (28 days before operation, 1st day, 10th day, 1month, 12month after operation) | Secondary: comparison of changes in anemia parameters(ferritin in ng/mL), comparison of changes in anemia parameters(ferritin in ng/mL), From 1 month before operation to 1 year after operation(28 days before operation, 1st day, 10th day, 1month, 12month after operation)|comparison of changes in anemia parameters(TSAT in %), comparison of changes in anemia parameters(TSAT in %), From 1 month before operation to 1 year after operation(28 days before operation, 1st day, 10th day, 1month, 12month after operation)|comparison of changes in anemia parameters(EPO level in mU/mL), comparison of changes in anemia parameters(EPO level in mU/mL), From 1 month before operation to 1 year after operation(28 days before operation, 1st day, 10th day, 1month, 12month after operation)|comparison of changes in hepcidin expression level in pg/mL, comparison of changes in hepcidin expression level in pg/mL, From 1 month before operation to 1 year after operation(28 days before operation, 1st day, 10th day, 1month, 12month after operation)|comparison of changes in oxidative stress marker, comparison of changes in oxidative stress marker(MDA in mmol/L, 4-HNE in pg/mL, NGAL in ng/mL), From 1 month before operation to 1 year after operation(28 days before operation, 1st day, 10th day, 1month, 12month after operation)|comparison of changes in immunologic parameters following the administration of intravenous iron therapy and EPO agent, comparison of changes in immunologic parameters(de novo DSA in MFI, antibody-mediated rejection rate in %, death censored graft survival and patient survival rate in %) following the administration of intravenous iron therapy and EPO agent, From 1 month before operation to 1 year after operation(28 days before operation, 1st day, 10th day, 1month, 12month after operation)
Sponsor/Collaborators: Sponsor: Yonsei University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 302
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-02
Completion Date: 2026-06
Results First Posted:
Last Update Posted: 2023-02-09
Locations: Yonsei University Health System, Severance Hospital, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT05719376