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

NCT04033276 | Completed Phase 4

• 1 other identifier: 20180138795
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Transplant

Outcome Measures

Primary Outcomes (1)

• change in delta DSA MFI sum

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

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

Secondary Outcomes (2)

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

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

• Development of antibody-mediated rejection (AMR)

  up to 1 year post-treatment

Study Arms (2)

Rituximab

ACTIVE COMPARATOR

Inj Rituximab 375mg/m2 IV given on day 0

Drug: Rituximab

Combination of high-dose IVIG and Rituximab

ACTIVE COMPARATOR

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

Drug: Rituximab; Drug: intravenous immune globulin

Interventions

Rituximab DRUG

IV rituximab

Also known as: mabthera

Combination of high-dose IVIG and Rituximab; Rituximab

intravenous immune globulin DRUG

iv intravenous immune globulin

Also known as: IVIG-SN

Combination of high-dose IVIG and Rituximab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Severance Hospital: collaborator
• GC Biopharma Corp: collaborator

Study Sites (2)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Related Publications (1)

• Kim HW, Lee J, Heo SJ, Kim BS, Huh KH, Yang J. Comparison of high-dose IVIG and rituximab versus rituximab as a preemptive therapy for de novo donor-specific antibodies in kidney transplant patients. Sci Rep. 2023 May 11;13(1):7682. doi: 10.1038/s41598-023-34804-6.

  PMID: 37169835 DERIVED

MeSH Terms

Interventions

Rituximab; Immunoglobulins, Intravenous

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immunoglobulin G; Immunoglobulin Isotypes

Study Officials

• Jaeseok Yang, M.D., Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 26, 2019
• Study Start: January 8, 2019
• Primary Completion: December 31, 2021
• Study Completion: May 3, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)