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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00121810
First received: July 15, 2005
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: mycophenolate mofetil [CellCept]
Drug: Corticosteroids
Drug: Calcineurin inhibitors
Drug: Sirolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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®)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12 [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24 [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]

    A secondary efficacy endpoint was mean percent change in renal function from baseline to 24 months postrandomization, as measured by Glomerular Filtration Rate utilizing renal clearance of cold iothalamate.

    percent change= [(Glomerular Filtration Rate at Month 24-Glomerular Filtration Rate at baseline)/Glomerular Filtration Rate at baseline]*100 percent.


  • Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24 [ Time Frame: baseline, 6, 12, and 24 months ] [ Designated as safety issue: No ]

    Renal allograft function determined by mean percent change from baseline in serum creatinine by treatment group at 6, 12, and 24 months postrandomization.

    percent change= [(serum creatinine at Month t-serum creatinine at baseline)/serum creatinine at baseline]*100 percent, where t=6, 12, and 24 months postrandomization.


  • Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24 [ Time Frame: baseline 6, 12, and 24 months ] [ Designated as safety issue: No ]

    Renal allograft function determined by mean percent change from baseline in calculated creatinine clearance (Cockroft and Gault method) by treatment group at 6, 12, and 24 months postrandomization.

    percent change= [(calculated creatinine clearance at Month t - calculated creatinine clearance at baseline)/calculated creatinine clearance at baseline]*100 percent, where t=6, 12, and 24 months postrandomization


  • Mean Percent Change in Calculated Glomerular Filtration Rate From Baseline to Months 6, 12, and 24 (Nankivell Equation) [ Time Frame: baseline, 6, 12, and 24 months ] [ Designated as safety issue: No ]

    Renal allograft function determined by mean percent change from baseline in calculated Glomerular Filtration Rate (Nankivell equation) by treatment group at 6, 12, and 24 months postrandomization.

    percent change= [(calculated Glomerular Filtration Rate at Month t - calculated Glomerular Filtration Rate at baseline)/calculated Glomerular Filtration Rate at baseline]*100 percent, where t=6, 12, and 24 months postrandomization.



Enrollment: 305
Study Start Date: August 2003
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: mycophenolate mofetil [CellCept]
1.0-1.5 g oral dose twice daily
Drug: Corticosteroids
As prescribed
Drug: Sirolimus
As prescribed
Active Comparator: 2 Drug: mycophenolate mofetil [CellCept]
1.0-1.5 g oral dose twice daily
Drug: Corticosteroids
As prescribed
Drug: Calcineurin inhibitors
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121810

  Hide Study Locations
Locations
United States, California
Bakersfield, California, United States, 93309
Los Angeles, California, United States, 90057
Los Angeles, California, United States, 90033
Palo Alto, California, United States, 94304-1509
Riverside, California, United States, 92501
San Diego, California, United States, 92123
San Francisco, California, United States, 94115
United States, Colorado
Denver, Colorado, United States, 80262
United States, Connecticut
Hartford, Connecticut, United States, 06106-3316
United States, District of Columbia
Washington, District of Columbia, United States, 20010-2975
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Maywood, Illinois, United States, 60153
United States, Indiana
Indianapolis, Indiana, United States, 46202-5124
Indianapolis, Indiana, United States, 46202
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Lexington, Kentucky, United States, 40536-0293
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston, Massachusetts, United States, 02114-2696
United States, Michigan
Detroit, Michigan, United States, 48202-2689
United States, New Jersey
Camden, New Jersey, United States, 08103
Livingston, New Jersey, United States, 07039
United States, New York
New York, New York, United States, 10029
New York, New York, United States, 10032
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati, Ohio, United States, 45267-0558
United States, Oregon
Portland, Oregon, United States, 97201
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Memphis, Tennessee, United States, 38104
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas, Texas, United States, 75246
Galveston, Texas, United States, 77555
San Antonio, Texas, United States, 78284
United States, Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00121810     History of Changes
Other Study ID Numbers: ML17140
Study First Received: July 15, 2005
Results First Received: November 18, 2009
Last Updated: April 13, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mycophenolate mofetil
Sirolimus
Everolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 28, 2014