The effect of intravenous iron therapy and erythropoesis-stimulation agent combination on renal transplant outcomes

The effect of intravenous iron therapy and erythropoesis-stimulation agent combination on renal transplant outcomes : INTERACT study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0008143

Enrollment

302

Registered

2023-01-17

Start date

2023-03-28

Completion date

Unknown

Last updated

2023-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Experimental : Monofer 200mg : OP-28day, OP-21day, OP-7day, OP day, POD #7 IV injection Mircera 120mcg SQ : OP-7 day~OP-1day Control: Ferritin<100, TSAT<20 : Monofer 200mg IV, twice Ferriti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. living donor transplantation (Age >19) 2. Ferririn<700?/L, TSAT<40%

Exclusion criteria

Exclusion criteria: 1. subject who is CDC(+), FXM(+) 2. Subject with a active infection 3. Hematologic malignancy, monoclonal gammaglobulin Dz, Hematologic Dz induced anemia 4. Receiving treatment of malignant tumor 5. Subject who is HIV(+) 6. Recent(within 3 months) participation in an interventional trial 7. ALT, AST >3 times upper limit of normal

Design outcomes

Primary

Measure	Time frame
Comparison of the number of blood transfusions according to the combination of intravenous iron therapy and EPO agent on perioperative period	—

Secondary

Measure	Time frame
comparison of changes in anemia parameters(ferritin, TSAT, EPO level) following the administraiton of intravenous iron therapy and EPO agent;comparison of changes in hepcidin expression level following the administraiton of intravenous iron therapy and EPO agent;comparison of changes in oxidative stress marker following the administraiton of intravenous iron therapy and EPO agent;comparison of changes in immunologic parameters(de novo DSA, antibody-mediated rejection rate, death censored graft survivial and patient survival rate) following the administraiton of intravenous iron therapy and EPO agent	—

Measure

Time frame

comparison of changes in anemia parameters(ferritin, TSAT, EPO level) following the administraiton of intravenous iron therapy and EPO agent;comparison of changes in hepcidin expression level following the administraiton of intravenous iron therapy and EPO agent;comparison of changes in oxidative stress marker following the administraiton of intravenous iron therapy and EPO agent;comparison of changes in immunologic parameters(de novo DSA, antibody-mediated rejection rate, death censored graft survivial and patient survival rate) following the administraiton of intravenous iron therapy and EPO agent

—

Countries

Korea, Republic of

Contacts

Public ContactHEE EUN CHO

Yonsei University Health System, Severance Hospital

trclinic@yuhs.ac+82-2-2228-5625

Outcome results