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

Renal Transplant Clinical Trial

Official title:

A Randomized, Open, Controlled Trial of High Dose IVIG/Rituximab Versus Rituximab in Kidney Transplant Patients With de Novo Donor-specific Antibodies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04033276
• Other study ID #: 20180138795
• Status: Completed
• Phase: Phase 4
• Start date: January 8, 2019
• Est. completion date: May 3, 2022

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 3, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Transplant

Intervention

Drug:
• Rituximab
IV rituximab
• intravenous immune globulin
iv intravenous immune globulin

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	GC Biopharma Corp, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	baseline and 3 months post-treatment, 1 year post-treatment
Secondary	Development of antibody-mediated rejection (AMR)	To identify the development of AMR after treatment during follow-up period	up to 1 year post-treatment