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

Conditions

• Acute Rejection
• Renal Transplantation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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).

Key Dates

Start date

Apr 30, 2006

Status verified

Jun 2012

Primary completion

Mar 31, 2007

Completion

Apr 30, 2007

Study Design

Enrollment

11 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 1
  Campath, Rituximab, Myfortic, and 10-20 days of cyclosporine

Primary Outcome Measure

renal function [ Time Frame: 2 years ]

Locations (1)

Find similar trials in Madison, WI

Related Studies

• Proteogenomic Monitoring and Assessment of Liver Transplant Recipients
  Recruiting · Northwestern University · Chicago, Illinois