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Completed

NCT Number: NCT04033276

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

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.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital, Seoul, South Korea

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About this study

Although recent advances in immunosuppressive regimens after kidney transplantation (KT) have reduced the incidence and consequences of T-cell-mediated rejection (TCMR) and have improved short-term outcomes, long-term allograft loss attributable to AMR is still responsible for substantial medical and socioeconomic burdens in kidney transplant recipients. Numerous studies have shown that de novo DSA after KT are associated with AMR, which leads to allograft loss. IVIG is a medication that has emerged as a useful tool in modulating immunity, treatment of AMR and in desensitization protocol. Treatment with rituximab or combination of IVIG/rituximab has sought to further diminish antibody production (de novo DSA) in the treatment of AMR. Several studies have been reported, but in the absence of control groups or standardization of treatment, their efficacy is difficult to assess.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients have de novo production of DR or DQ DSA after renal transplantation Inclusion criteria requires all of the following

  • 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
  • history of malignancy within 5 years
  • history of treatment for psychiatric problems
  • hematologic or biochemical abnormalities (Hb < 7g/dL, Platelet < 1x105/mm3, AST/ALT > 80IU)
  • A patient who do not want to participate in this study

Treatment and study plan

Rituximab

Drug

IV rituximab

Other names: mabthera

intravenous immune globulin

Drug

iv intravenous immune globulin

Other names: IVIG-SN

Primary outcomes

  1. change in delta DSA MFI sum

    Time frame: baseline and 3 months post-treatment, 1 year post-treatment

    change of pre- and post-treatment DSA MFI sum, monitoring DSA during follow-up period

Secondary outcomes

  1. Change in estimated glomerular filtration rate(eGFR) by CKD-EPI equation

    Time frame: baseline and 3 months post-treatment, 1 year post-treatment

    change of pre- and post-treatment eGFR by CKD-EPI equation, monitoring eGFR during follow-up period

  2. Development of antibody-mediated rejection (AMR)

    Time frame: up to 1 year post-treatment

    To identify the development of AMR after treatment during follow-up period

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • GC Biopharma Corp
  • Severance Hospital

Registry information

Official study title

A Randomized, Open, Controlled Trial of High Dose IVIG/Rituximab Versus Rituximab in Kidney Transplant Patients With de Novo Donor-specific Antibodies

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 26, 2019
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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