Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
An Open Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Early Calcineurin Inhibitor Withdrawal in Recipients of Primary Renal Allografts Maintained Long-term on Mycophenolate Mofetil (MMF) (CellCept®) and Sirolimus (Rapamune®)
1 other identifier
interventional
305
1 country
36
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2003
Longer than P75 for phase_4
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 15, 2005
CompletedFirst Posted
Study publicly available on registry
July 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
February 24, 2011
CompletedApril 15, 2011
April 1, 2011
6.3 years
July 15, 2005
November 18, 2009
April 13, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12
The primary efficacy endpoint was mean percent change in renal function from baseline to 12 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate. percent change= \[(Glomerular Filtration Rate at Month 12-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline\]\*100 percent.
baseline to 12 months
Secondary Outcomes (4)
Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24
Baseline to 24 months
Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24
baseline, 6, 12, and 24 months
Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24
baseline 6, 12, and 24 months
Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation)
baseline, 6, 12, and 24 months
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Unknown Facility
Bakersfield, California, 93309, United States
Unknown Facility
Los Angeles, California, 90033, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Palo Alto, California, 94304-1509, United States
Unknown Facility
Riverside, California, 92501, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Hartford, Connecticut, 06106-3316, United States
Unknown Facility
Washington D.C., District of Columbia, 20010-2975, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Maywood, Illinois, 60153, United States
Unknown Facility
Indianapolis, Indiana, 46202-5124, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Lexington, Kentucky, 40536-0293, United States
Unknown Facility
New Orleans, Louisiana, 70112, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Boston, Massachusetts, 02114-2696, United States
Unknown Facility
Detroit, Michigan, 48202-2689, United States
Unknown Facility
Camden, New Jersey, 08103, United States
Unknown Facility
Livingston, New Jersey, 07039, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cincinnati, Ohio, 45267-0558, United States
Unknown Facility
Portland, Oregon, 97201, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Sioux Falls, South Dakota, 57105, United States
Unknown Facility
Memphis, Tennessee, 38104, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Galveston, Texas, 77555, United States
Unknown Facility
San Antonio, Texas, 78284, United States
Unknown Facility
Charlottesville, Virginia, 22908, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 15, 2005
First Posted
July 21, 2005
Study Start
August 1, 2003
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
April 15, 2011
Results First Posted
February 24, 2011
Record last verified: 2011-04