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Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant

NCT00928811 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-02-10

No results posted yet for this study

Summary

The study is undertaken to explore the safety of using Simulect at monthly dose intervals to reduce the need of high dose/level CNI's such as Prograf.

Conditions

Interventions

DRUG

basiliximab

Simulect 20 mg intravenously day of transplant and day 4

DRUG

basiliximab

Simulect (basiliximab) 20mg intravenously day of transplant and day 4 post operatively. Then Monthly administration of Simulect (basiliximab) 40 mg intravenously for one year duration.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Drexel University College of Medicine

    lead OTHER

Principal Investigators

  • Mysore Anil S. Kumar, MD · Drexel University College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT00928811 on ClinicalTrials.gov