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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214266
First received: September 13, 2005
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Renal Transplantation
Drug: Campath 1H®, Rituximab, mycophenolate mofetil
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • renal allograft function [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of hypertension [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • incidence of diabetes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • drug related side effects [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: January 2005
Study Completion Date: September 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214266     History of Changes
Other Study ID Numbers: 2004-0209
Study First Received: September 13, 2005
Last Updated: June 22, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Rituximab
Alemtuzumab
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 14, 2014