Status:
COMPLETED
Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroid...
Eligibility Criteria
Inclusion
- Adult patients 18-75 years of age
- Kidney transplant 30-180 days post-transplantation
- Receipt of cyclosporine or tacrolimus, CellCept, and corticosteroids for greater than 14 days prior to study entry
- No known contraindications to sirolimus
Exclusion
- Multiple organ transplant recipients or secondary kidney transplant recipients
- Corticosteroid-resistant rejection episode within 90 days prior to study entry or corticosteroid-sensitive rejection episode within 30 days prior to study entry
- More than 1 biopsy-proven episode of acute rejection prior to study entry
- Treated with sirolimus before the study
- Organ transplant or expected organ transplant, other than kidney
- History of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT00121810
Start Date
August 1 2003
End Date
November 1 2009
Last Update
April 15 2011
Active Locations (36)
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1
Bakersfield, California, United States, 93309
2
Los Angeles, California, United States, 90033
3
Los Angeles, California, United States, 90057
4
Palo Alto, California, United States, 94304-1509