MedTrace Logo

A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

NCT00048152 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 539

Last updated 2016-11-02

No results posted yet for this study

Summary

This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Corticosteroids

As prescribed

DRUG

Neoral

Low dose (target trough level 50-100ng/mL)

DRUG

Neoral

Standard dose (target trough level 150-300ng/mL)

DRUG

Zenapax

2mg/kg iv first dose, then 1mg/kg every 2 weeks

DRUG

mycophenolate mofetil [CellCept]

1g po bid

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-12-31
Primary Completion
2006-03-31
Completion
2006-03-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • Mexico
  • Norway
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00048152 on ClinicalTrials.gov