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A Pilot Study of Campath-1H Induction Therapy Combined With CellCept® Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation

NCT00214266 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-05-30

No results posted yet for this study

Summary

The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation. Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine. However, the advantage of a calcineurin inhibitor free regimen may include improved renal allograft function, a lower incidence of hypertension, diabetes, and less drug related side effects. This is a non-randomized open-label pilot trial in 30 adult renal transplant patients.

Conditions

  • Renal Transplantation

Interventions

DRUG

Campath 1H®, Rituximab, mycophenolate mofetil

Induction therapy with Campath 30mg IV x 2 doses, Rituximab 375mg/m2 x 1, corticosteroids, and mycophenolate 1000mg bid

Sponsors & Collaborators

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Hans Sollinger, MD · University of Wisconsin, Madison

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-08-31
Completion
2007-09-30

Countries

  • United States

Study Locations

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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 NCT00214266 on ClinicalTrials.gov