The Effect of Rituximab on the Development of Anti-Donor Antibodies

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of California, San Francisco
Study ID
NCT00695097
Status
Completed

Conditions

  • Renal Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The aim of the study is to find out if Rituximab, which is an antibody against specific white cells involved in rejection, when combined with standard anti-rejection treatment can more effectively reverse the rejection process. Our hypothesis is that with acute rejection there is activation of B cells and the subsequent development of anti-donor antibodies that ultimately lead to graft loss. More effective therapy targeted at B cells may abort the development of anti-HLA antibodies, prevent renal injury and have a favorable effect on long-term graft outcome.

Key Dates

Start date
Aug 31, 2004
Status verified
Feb 2014
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Rituximab Group: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15) and followed up monthly for 1 year. Biopsy was done Baseline and Month 3 and other labs (CBC/Diff, Platelets, HACA, PK, Serum Creatinine, 24-hour protein, HLA antibodies, flow cytometry, and serology testing). Physical exam and vital signs were done.
  • Active Comparator: 2
    No Rituximab: received standard immunosuppression and was followed up monthly for 1 year. Labs (CBC/Diff, Platelets, HACA, PK, Serum Creatinine, 24-hour protein, HLA antibodies, flow cytometry, and serology testing) vital signs, and physical exam was done.

Primary Outcome Measure

Change in Biopsy Cell Densities From Baseline to Follow-up [ Time Frame: 1 year ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
UCSF-Kidney Transplant ClinicSan FranciscoCalifornia94143-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUCSF-Kidney Transplant Clinic· San Francisco, CA

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