Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients

Completed · Phase 4

Conditions studied: Kidney Transplantation

In brief

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 corticosteroids. They were either randomized to continue this regimen, or CNI therapy was discontinued and replaced by sirolimus therapy (in combination with CellCept and corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

Key facts

Study ID

NCT00121810

Run by

Hoffmann-La Roche

People needed

305

Starts

2003-08-01

Expected to finish

2009-11-01

Last updated by the study team

2011-04-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Study site — Bakersfield, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palo Alto, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Denver, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Maywood, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Lexington, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Camden, New Jersey, United States
• Study site — Livingston, New Jersey, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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