Effects of B-cell depletion on clinical outcomes and histopathology of renal transplantation

The effect of B-cell depletion versus no induction therapy on clinical outcomes and histopathology in renal transplant recipients

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000420044

Enrollment

Registered

2010-05-26

Start date

2008-08-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Can B cell depletion during the early phase of renal transplantation reduce HLA antibody production and lessen chronic allograft rejection?

Interventions

B cell depletion by intravenous infusion of 500mg of rituximab in saline over one hour once only before reperfusion. The intervention group also receives immunosuppressive therapy including tacrolimus, mycophenolate mofetil and corticosteroids.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

15 Years to 65 Years

Healthy volunteers

Inclusion criteria

Male or female patients at 15-65 years of age undergoing renal transplantation Patients who have been informed of the potential risks and side effects of the study Patients who have given written informed consent to participate in the study

Exclusion criteria

Donor age greater than 65 years Patients receiving a perfectly matched kidney (6 matches HLA A, B, DR) Patients who are recipients of multiple solid organ transplants Patients undergoing second or subsequent transplantation

Outcome results