Campath, Rituximab, and Myfortic With Short-Course Calcineurin Inhibitor Therapy in Renal Transplanation - Full Text View

Sponsored by:	University of Wisconsin, Madison
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00579592

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 for an indefinite period of time. However, the advantage of a long term, 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. Subjects will receive 2 doses of Campath-1H (30mg given on Day 0 and Day 1) and a single dose of Rituximab (375mg/m2) on Day 0, given intra-operative. Subjects will take maintenance doses of prednisone and enteric coated mycophenolate sodium (Myfortic™). Subject will also be given cyclosporine (Neoral®) therapy for approximately 2 weeks (10-20 days).

Condition	Intervention
Acute Rejection Renal Transplantation	Drug: Campath-1H, rituximab, myfortic

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of Campath-1H Induction Therapy Combined With Rituximab®, Myfortic™ and a Short Course of Calcineurin Inhibitor Therapy to Allow for a Long Term Calcineurin Inhibitor Free Regimen After Renal Transplantation

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Kidney Transplantation

Drug Information available for: Mycophenolic acid Campath Rituximab Alemtuzumab

U.S. FDA Resources

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

Primary Outcome Measures:

renal function [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

hypertension [ Time Frame: 2 years ] [ Designated as safety issue: No ]
drug side effects [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment:	11
Study Start Date:	April 2006
Estimated Study Completion Date:	November 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Campath, Rituximab, Myfortic, and 10-20 days of cyclosporine	Drug: Campath-1H, rituximab, myfortic Campath-1H 30mg IV x 2 doses, rituximab 375mg/m2 IV x 1 dose, myfortic 720mg bid, cyclosporine po bid (target trough 200ng/ml) x 10-20 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Recipient of cadaver or non HLA identical living donor transplantation (tx), Re-tx recipient (second tx) allowed, but no organ other than a kidney (ie no prev k/p)
Females of CBP must have neg preg test at the time of study enrollment (SOC) & agree to practice birth control for duration of the study, or for 6 weeks after the last dose of Myfortic

Exclusion Criteria:

Subjects who are pregnant or nursing.
Current malignancy or a malignancy in the past 5 years, except for excised skin CA (BCC or SC)
Multi-organ tx, ABO incompatible and + CM
Subjects with a current PRA >50% within the past 30 days pre tx
Subjects with active current infection requiring continued use of antibiotics, or the presence of chronic active hepatitis B (surface antigen +) or +HCV.
Exclude for subjects who have received an investigational drug within 4 weeks of study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579592

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, PhD

University of Wisconsin, Madison

More Information

No publications provided

Responsible Party:	University of Wisconsin ( Hans Sollinger, MD, PhD )
Study ID Numbers:	H-2005-0454
Study First Received:	December 17, 2007
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00579592 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Bacterial Agents
Cyclosporine
Immunologic Factors
Rituximab

Alemtuzumab
Mycophenolic Acid
Antirheumatic Agents
Cyclosporins

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Rituximab
Therapeutic Uses
Alemtuzumab

Physiological Effects of Drugs
Mycophenolic Acid
Enzyme Inhibitors
Antirheumatic Agents
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009