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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-08

Study Completion Date

2022-05-03

Brief Summary

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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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Detailed Description

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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.

Conditions

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Renal Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Rituximab

Inj Rituximab 375mg/m2 IV given on day 0

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type DRUG

IV rituximab

Combination of high-dose IVIG and Rituximab

IV Rituximab 375mg/m2 on day 0 and IV high-dose IVIG 2g/kg on day 0

Group Type ACTIVE_COMPARATOR

Rituximab

Intervention Type DRUG

IV rituximab

intravenous immune globulin

Intervention Type DRUG

iv intravenous immune globulin

Interventions

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Rituximab

IV rituximab

Intervention Type DRUG

intravenous immune globulin

iv intravenous immune globulin

Intervention Type DRUG

Other Intervention Names

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mabthera IVIG-SN

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No