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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Green Cross Corporation; Severance Hospital
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Rituximab

Criteria

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