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Immunosuppressant

1 for Transplant Rejection

Phase 4
Waitlist Available
Led By John Gill
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
De Novo, single Kidney recipient
At least 1 HLA mismatch
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post transplant
Awards & highlights

Study Summary

This study has been designed to test whether using Thymoglobulin with low dose Cyclosporine and early steroid dosage reduction will minimize both kidney rejection and the development of new onset diabetes mellitus after renal transplant.

Eligible Conditions
  • Diabetes
  • Transplant Rejection

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients developing New Onset Diabetes post transplant, as identified by an oral glucose tolerance test
Secondary outcome measures
Incidence of acute rejection

Side effects data

From 2010 Phase 4 trial • 200 Patients • NCT01172418
29%
Patients who developed an infection that required hospitalization
11%
occurrence of NODAT in patients without pretransplant diabetes
100%
80%
60%
40%
20%
0%
Study treatment Arm
Thymoglobulin and Daclizumab
Thymoglobulin and Alemtuzumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
All subjects meeting the entry criteria will be treated with the study immunosuppressive protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyIndustry Sponsor
524 Previous Clinical Trials
85,612 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,465 Previous Clinical Trials
483,659 Total Patients Enrolled
Unity Health TorontoOTHER
535 Previous Clinical Trials
447,049 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol
2008. "Thymoglobulin in Calcineurin Inhibitor and Steroid Minimization Protocol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00706680.
All > Restasis
~2 spots leftby Apr 2025
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