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

NCT00476515 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-10-23

No results posted yet for this study

Summary

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.

Conditions

  • Kidney Insufficiency

Interventions

DRUG

Rituximab

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).

Sponsors & Collaborators

  • Biogen

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Nina Tolkoff-Rubin, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2007-09-30
Completion
2007-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00476515 on ClinicalTrials.gov