Randomized, open, controlled trial for combination therapy of high-dose IVIG and rituximab in kidney transplant patients with de novo donor-specific antibodies

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0010459

Enrollment

Registered

2025-05-08

Start date

2019-01-08

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : (1) Experimental group and control group: administration of Mabthera (rituximab, 375 mg/m2, maximum 500 mg) on day 0 . (2) Experimental group: administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) age 19 or older (2) CKD-EPI eGFR 20 ml/min or higher and eGFR aggravation less than 20% for the past 3 months (3) Absence of Gr-I or higher acute T cell mediated rejection or acute antibody-mediated rejection during the past 3 months (4) DR DQ de novo DSA peak MFI 1,000 or higher (5) Written informed consent

Exclusion criteria

Exclusion criteria: (1) 18 years old or younger (2) simultaneous multiorgan transplantation (3) absence of tacrolimus (4) Allergy to rituximab (5) HIV antibody positive (6) Current infection under treatment or history of antibiotics within 4 weeks (7) pregnancy or breast feeding (8) durg or alcohol during the past 6 months (9) malignancy treatment during the past 6 months (10) Psychiatric treatment history (11) Hb80 IU (12) refusal to participate in this study

Design outcomes

Primary

Measure	Time frame
delta DSA peak MFI and MFI sum	—

Secondary

Measure	Time frame
delta DSA peak MFI and MFI sum	—

Countries

Korea, Republic of

Contacts

Public ContactJAESEOK YANG

Seoul National University Hospital

jcyjs@snu.ac.kr+82-2-2228-1949

Outcome results