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Corticosteroid

Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin] for Kidney Transplant

Phase 4
Waitlist Available
Research Sponsored by Simon Tremblay, PharmD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This study is evaluating whether a combination of medications may help prevent rejection of a kidney transplant.

Eligible Conditions
  • Kidney Transplant
  • Immunosuppression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with the combination oral outcome of Biopsy-proven acute rejection, patient death and graft loss

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prospective ArmExperimental Treatment6 Interventions
De novo kidney transplant recipients receiving: rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Once-daily tacrolimus XR 0.8mg/kg/day started when or when serum creatinine is <4mg/dL or by 48 hours of transplant to target 24-hr trough levels of 8-12ng/mL up to day 30 followed by 24-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery
Group II: Comparator armActive Control6 Interventions
Historical control arm consisting of the following De novo kidney transplant recipients receiving: rabbit antithymocyte globulin induction (1.5mg/kg, dosage range 4-6mg/kg total dose over 5-10 days) 5-day steroid withdrawal (methylprednisolone 500mg IV on day 1 (day of transplant), 250mg IV on day 2, 125mg IV on day 3, prednisone 80mg PO on day 4, 60mg PO on day 5 and then no more steroids Twice-daily tacrolimus 0.1mg/kg/day started when or when serum creatinine is <4mg/dL or by 48 hours of transplant to target 12-hr trough levels of 8-12ng/mL up to day 30 followed by 12-hour trough targets of 5-10ng/mL Mycophenolate mofetil (1000 mg PO BID) or mycophenolic acid (720mg PO BID) twice daily started prior to surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate mofetil
FDA approved
Tacrolimus
FDA approved
Prednisone
FDA approved
Methylprednisolone
FDA approved

Find a Location

Who is running the clinical trial?

Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,086 Total Patients Enrolled
Simon Tremblay, PharmD, PhDLead Sponsor

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
Veloxis de Novo Kidney Transplant ECSWD
Simon Tremblay, PharmD, PhD 2019. "Veloxis de Novo Kidney Transplant ECSWD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03828682.
All > Kidney Transplant
~10 spots leftby Apr 2025
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