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

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 II

MedlinePlus related topics:

High Blood Pressure Kidney Transplantation

Drug Information available for:

Rituximab Alemtuzumab Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Corticosteroids Campath

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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 ]

Estimated Enrollment:	30
Study Start Date:	December 2005
Estimated Study Completion Date:	March 2008

Intervention Details:

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

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

Responsible Party:	University of Wisconsin ( Hans Sollinger, MD )
Study ID Numbers:	2004-0209
First Received:	September 13, 2005
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00214266
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Rituximab

Alemtuzumab

Mycophenolate mofetil

Additional relevant MeSH terms:

Immunologic Factors

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Antirheumatic Agents

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 04, 2008

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00214266