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

Seoul National University Hospital50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Renal Transplant

Interventions

RituximabDRUG

IV rituximab

intravenous immune globulinDRUG

iv intravenous immune globulin

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: All patients have de novo production of DR or DQ DSA after renal transplantation Inclusion criteria requires all of the following 1. age ≥ 19 years 2. Renal transplants with eGFR ≥ 20 ml/min (by CKD-EPI equation) and change in the eGFR ≤ 20 within 3 months 3. No history of biopsy proven acute T cell mediated rejection or antibody-mediated rejection within 3 months 4. peak MFI of de novo DSA (DR or DQ) ≥ 1000 5. A patient who agree to write a written consent form Exclusion Criteria: 1. age ≤ 18 years 2. multi-organ transplantation 3. Patients with no history of tacrolimus as immunosuppressants 4. history of allergic or anaphylactic reaction to rituximab 5. human immunodeficiency virus infection 6. active infection 7. pregnancy or lactation 8. history of drug abuse or alcohol abuse within 6 months 9. history of malignancy within 5 years 10. history of treatment for psychiatric problems 11. hematologic or biochemical abnormalities (Hb \< 7g/dL, Platelet \< 1x105/mm3, AST/ALT \> 80IU) 12. A patient who do not want to participate in this study

Locations (2)

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

change in delta DSA MFI sum

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

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

Secondary Outcomes

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

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

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

Development of antibody-mediated rejection (AMR)

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

Time frame: up to 1 year post-treatment

Data from ClinicalTrials.gov

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