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

NCT00579592 | Terminated DMC

• 1 other identifier: H-2005-0454
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Rejection; Renal Transplantation

Outcome Measures

Primary Outcomes (1)

• renal function

  2 years

Secondary Outcomes (2)

• hypertension

  2 years

• drug side effects

  2 years

Study Arms (1)

1

EXPERIMENTAL

Campath, Rituximab, Myfortic, and 10-20 days of cyclosporine

Drug: Campath-1H, rituximab, myfortic

Interventions

Campath-1H, rituximab, myfortic DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Alemtuzumab; Rituximab; Mycophenolic Acid

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Hans Sollinger, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 24, 2007
• Study Start: April 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: April 1, 2007
• Last Updated: June 26, 2012

Record last verified: 2012-06

Locations

US (1)