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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

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ClinicalTrials.gov Identifier: NCT00214266
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : June 26, 2012
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Transplantation Drug: Campath 1H®, Rituximab, mycophenolate mofetil Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Campath-1H Induction Therapy Combined With CellCept® Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation
Study Start Date : January 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : September 2007


Arm Intervention/treatment
Experimental: Campath-1H Induction Therapy Combined With CellCept® Therapy
Campath-1H Induction Therapy Combined With CellCept® Therapy
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



Primary Outcome Measures :
  1. renal allograft function [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. incidence of hypertension [ Time Frame: 2 years ]
  2. incidence of diabetes [ Time Frame: 2 years ]
  3. drug related side effects [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • renal transplant recipients

Exclusion Criteria:

  • Recipients of HLA-identical living-donor renal transplants;
  • multi-organ transplant;
  • known hypersensitivity to Campath-1H, Rituximab, CellCept, or prednisone;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214266


Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Hans Sollinger, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214266     History of Changes
Other Study ID Numbers: 2004-0209
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Alemtuzumab
Rituximab
Mycophenolic Acid
Calcineurin Inhibitors
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action