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Simultaneous Pancreas-kidney Transplantation With Campath Protocol

NCT00316810 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-06-19

No results posted yet for this study

Summary

The purpose of this study is to determine and compare the efficacy of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF therapy in conjunction with initial short-term steroids in Type 1-diabetic patients undergoing simultaneous pancreas-kidney allograft transplantation as well as to evaluate the safety of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF in terms of drug-related complications and immunosuppression-associated complications.

Conditions

  • Pancreas-Kidney Transplantation

Interventions

DRUG

Alemtuzumab

Day 0: Campath 30 mg i.v. infusion over 3-6 hours

DRUG

Rabbit Anti-Human Thymocyte Globulin

Day O: Single shot of a polyclonal antilymphocyte preparation (ATG-Fresenius - 8 mg/kg, or IMTIX-Sangstat ATG 4 mg/kg/day).

Sponsors & Collaborators

  • Astellas Pharma GmbH

    collaborator INDUSTRY

  • Dr. Claudia Bösmüller

    lead OTHER

Principal Investigators

  • Johann Pratschke, Prof. Dr. · University Hospital Innsbruck, Dept. of General- and Transplant Surgery, Anichstrasse 35, A-6020 Innsbruck

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2011-02-28
Completion
2011-06-30

Countries

  • Austria

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 NCT00316810 on ClinicalTrials.gov