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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00579592
Recruitment Status : Terminated (Higher than expected rate of acute rejection)
First Posted : December 24, 2007
Last Update Posted : June 26, 2012
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 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 or disease Intervention/treatment Phase
Acute Rejection Renal Transplantation Drug: Campath-1H, rituximab, myfortic Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 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 Rituximab®, Myfortic™ and a Short Course of Calcineurin Inhibitor Therapy to Allow for a Long Term Calcineurin Inhibitor Free Regimen After Renal Transplantation
Study Start Date : April 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : April 2007

Arm Intervention/treatment
Experimental: 1
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

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

Secondary Outcome Measures :
  1. hypertension [ Time Frame: 2 years ]
  2. drug side effects [ Time Frame: 2 years ]

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

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

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 identifier (NCT number): NCT00579592

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

Responsible Party: University of Wisconsin, Madison Identifier: NCT00579592     History of Changes
Other Study ID Numbers: H-2005-0454
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012

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