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

Not Applicable

Terminated

• Conditions: Acute Rejection; Renal Transplantation
• Interventions: Drug: Campath-1H, rituximab, myfortic

• Registration Number: NCT00579592
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-03
• Study Completion: 2007-04
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-24
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-22
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Campath-1H, rituximab, myfortic	Campath, Rituximab, Myfortic, and 10-20 days of cyclosporine

Primary Outcome Measures

Name	Time	Method
renal function	2 years

Secondary Outcome Measures

Name	Time	Method
hypertension	2 years
drug side effects	2 years

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States