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Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation

NCT00177138 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2013-02-07

No results posted yet for this study

Summary

This is a single center, prospective, open-label, randomized trial at the University of Minnesota Medical Center,Fairview.

Primary objectives are to determine if rejection episodes and loss rates, graft survival, level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1) immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin, tacrolimus, and MMF (Group 2).

This study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients.

Conditions

Interventions

DRUG

Tacrolimus

Starting POD #1 0.06 mg/kg/day in 2 divided doses;

DRUG

Alemtuzumab

30 mg IV intra-op and POD #12; then 30 mg IV \>monthly for 1 year (only if ALC\>200 mm, up to a total of 10 doses in year)

Sponsors & Collaborators

Principal Investigators

  • Rainer W Gruessner, M.D. · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Completion
2006-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00177138 on ClinicalTrials.gov