A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients
Recruiting in Palo Alto (17 mi)
+26 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Waitlist Available
Sponsor: Astellas Pharma Inc
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept
Research Team
cc
central contact
Principal Investigator
Astellas Pharma US, Inc.
Eligibility Criteria
Inclusion Criteria
Patient is between post kidney transplant day 3-7 and no requirement for dialysis
Patient is receiving kidney from HLA identical,living donor Patient is a multi-organ transplant recipient
Patient is pregnant or lactating. Female patients of child bering potential must have a negative pregnancy test and agree to practice effective birth contro
Treatment Details
Interventions
- CellCept (Antiproliferative Agent)
- Methylprednisone or Prednisone (Corticosteroid)
- Tacrolimus (Calcineurin Inhibitor)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment3 Interventions
long-term maintenance steroids
Group II: 1Experimental Treatment3 Interventions
early steroid cessation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT00650468Cincinnati, OH
NCT00650468Nashville, TN
NCT00650468Galveston, TX
NCT00650468Little Rock, AR
More Trial Locations
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Who Is Running the Clinical Trial?
Astellas Pharma Inc
Lead Sponsor
Trials
700
Patients Recruited
236,000+
Headquarters
Tokyo, Japan
Top Products
- Xtandi (enzalutamide) for prostate cancer, - Xospata (gilteritinib) for AML, - Padcev (enfortumab vedotin) for bladder cancer, - Prograf (tacrolimus) for organ rejection prevention