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

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ClinicalTrials.gov Identifier: NCT00579592
Recruitment Status : Terminated (Higher than expected rate of acute rejection)
First Posted : December 24, 2007
Last Update Posted : June 26, 2012
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

December 17, 2007
December 24, 2007
June 26, 2012
April 2006
March 2007   (Final data collection date for primary outcome measure)
renal function [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00579592 on ClinicalTrials.gov Archive Site
  • hypertension [ Time Frame: 2 years ]
  • drug side effects [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
Campath, Rituximab, and Myfortic With Short-Course Calcineurin Inhibitor Therapy in Renal Transplanation
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
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).
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Rejection
  • Renal Transplantation
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
Experimental: 1
Campath, Rituximab, Myfortic, and 10-20 days of cyclosporine
Intervention: Drug: Campath-1H, rituximab, myfortic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
Same as current
April 2007
March 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00579592
H-2005-0454
Yes
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Hans Sollinger, MD, PhD University of Wisconsin, Madison
University of Wisconsin, Madison
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP