Comparison Between Bortezomib and Rituximab Plus Plasmapheresis in AMR

Antibody-mediated Rejection Clinical Trial

Official title:

Comparison Between Rituximab + PLX + IVIG With and Without Bortezomib in the Treatment of Antibody Mediated Kidney Transplanted Rejection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03737136
• Other study ID #: SMBU11254/B
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: October 1, 2025

Study information

• Verified date: July 2023
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Nooshin Dalili, Dr
• Phone: 00989122404331
• Email: nooshindalili4[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic-active antibody-mediated rejection (cAMR) due to de novo or pre-formed donor specific antibody (DSA) is currently considered the main cause of long-term allograft losses.Based on the aim of reducing or eliminating DSA, some proposed different therapeutic regimens for cAMR treatment. All of these protocols were derived from previous experience using acute antibody-mediated rejection and desensitization protocols, and mainly consisted of steroids, plasma exchange (PE), IVIG and RTX in various modalities. More recently, bortezomib was also proposed.To evaluate the role of a therapeutic regimen with plasma exchange, intravenous immunoglobulins and rituximab with or without Bortezomib in chronic-active antibody-mediated rejection (cAMR) settings this study designed.

Description:

20 kidney transplant recipients (KTRs) with a diagnosis of cAMR in a prospective randomized clinical trial will be recruited in two arms : ten KTRs treated with plasmapheresis, intravenous immunoglobulins and rituximab (PE-IVIG-RTX group) vs 10 patients receiving the same therapy plus Bortezomib. Differences between transplanted kidney survival and functional outcomes 6 mo after diagnosis and histological features and donor-specific antibody (DSA) characteristics (MFI ) will be investigated between two arms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2025
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients presented with renal biopsy demonstrating ABMR in the absence of T-cell-mediated rejection

Exclusion Criteria:

• Mixed AMR and T cell rejection
• do not sign the consent

Related Conditions & MeSH terms

• Antibody-mediated Rejection

Intervention

Drug:
• Bortezomib
one cycle of bortezomib (each cycle: 1.3mg/m2 intravenously on days 1, 4, 8, and 11)

Locations

Country	Name	City	State
Iran, Islamic Republic of	SBMU	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	graft survival	Glomerular Filtration Rate	at month 6 following diagnosis
Secondary	Renal functional tests	Serum Cr	at month 6 following diagnosis
Secondary	Changes in Grading of antibody mediated rejection regarding Banff criteria in pathology	kidney biopsy	at month 6 following diagnosis
Secondary	DSAs-MFI	Serum Test	at month 6 following diagnosis