CompletedPhase 4

IVIG/Rituximab vs Rituximab in Kidney Transplant With de Novo Donor-specific Antibodies

South Korea50 participantsStarted 2019-01-08

Plain-language summary

The objective of this study was to compare two strategies of de novo donor specific antibodies (DSA) and antibody-mediated rejection (AMR) prevention in renal transplant recipients: high dose intravenous immunoglobulin (IVIG)/rituximab regimens versus rituximab alone.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. age ≥ 19 years
✓. Renal transplants with eGFR ≥ 20 ml/min (by CKD-EPI equation) and change in the eGFR ≤ 20 within 3 months
✓. No history of biopsy proven acute T cell mediated rejection or antibody-mediated rejection within 3 months
✓. peak MFI of de novo DSA (DR or DQ) ≥ 1000
✓. A patient who agree to write a written consent form

Exclusion criteria

✕. age ≤ 18 years
✕. multi-organ transplantation
✕. Patients with no history of tacrolimus as immunosuppressants
✕. history of allergic or anaphylactic reaction to rituximab
✕. human immunodeficiency virus infection
✕. active infection
✕. pregnancy or lactation
✕. history of drug abuse or alcohol abuse within 6 months

What they're measuring

change in delta DSA MFI sum

Timeframe: baseline and 3 months post-treatment, 1 year post-treatment

Trial details

NCT IDNCT04033276

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

View on ClinicalTrials.gov More Renal Transplant trials