Rituximab Therapy for Patients on Kidney Transplant Waiting List With Positive Donor Specific Crossmatch to Living Donor

Conditions

• Kidney Insufficiency

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  the recommended dosage of Rituximab is 375 mg/m2 given as an IV infusion once weekly for four doses (days 1, 8, 15, and 22).

Study Details

Primary Objectives: * Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful renal transplantation. * Transplant success or failure following the desensitization protocol. * Determination of the effect of rituximab on the kinetics of donor specific antibodies (DSA). * Determination of the effect of rituximab on the kinetics of B-cell subpopulations in peripheral blood and/or secondary lymphoid organs (lymph node biopsies at time of transplant, if available) in both responders and non-responders using flow cytometry and/or immunohistochemistry. Secondary Objectives: -Decrease in incidence of humoral rejection to less than 50 % at 1 year.

Key Dates

Start date

Mar 31, 2007

Status verified

Oct 2023

Primary completion

Sep 30, 2007

Completion

Sep 30, 2007

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab
  this study has only one arm as treatment group.

Primary Outcome Measure

Subjects who convert to a negative donor specific crossmatch or eliminate donor specific antibody will be considered a TREATMENT SUCCESS and will undergo target living donor transplantation in 3-5 days [ Time Frame: 4 weeks after the final dose of Rituximab ]