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

Renal Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214266
• Other study ID #: H-2004-0209
• Status: Completed
• Phase: Phase 2
• Start date: January 2005
• Est. completion date: September 2007

Study information

• Verified date: May 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal allograft function		2 years
Secondary	incidence of hypertension		2 years
Secondary	incidence of diabetes		2 years
Secondary	drug related side effects		2 years