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

Phase 4

Completed

• Conditions: Renal Transplant
• Interventions: Drug: Rituximab; Drug: intravenous immune globulin

• Registration Number: NCT04033276
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-01-08
• Study First Submitted: 2019-07-24
• Study First Submitted QC: 2019-07-24
• Study First Posted: 2019-07-26
• Primary Completion: 2021-12-31
• Status Verified: 2022-05
• Study Completion: 2022-05-03
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination of high-dose IVIG and Rituximab	intravenous immune globulin	IV Rituximab 375mg/m2 on day 0 and IV high-dose IVIG 2g/kg on day 0
Combination of high-dose IVIG and Rituximab	Rituximab	IV Rituximab 375mg/m2 on day 0 and IV high-dose IVIG 2g/kg on day 0
Rituximab	Rituximab	Inj Rituximab 375mg/m2 IV given on day 0

Primary Outcome Measures

Name	Time	Method
change in delta DSA MFI sum	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 Outcome Measures

Name	Time	Method
Change in estimated glomerular filtration rate(eGFR) by CKD-EPI equation	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
Development of antibody-mediated rejection (AMR)	up to 1 year post-treatment	To identify the development of AMR after treatment during follow-up period

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of