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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

July 15, 2005
April 13, 2011
August 2003
November 2009   (final data collection date for primary outcome measure)
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.

Not Provided
Complete list of historical versions of study NCT00121810 on ClinicalTrials.gov Archive Site
  • 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.

Not Provided
Not Provided
Not Provided
 
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®)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: mycophenolate mofetil [CellCept]
    1.0-1.5 g oral dose twice daily
  • Drug: Corticosteroids
    As prescribed
  • Drug: Calcineurin inhibitors
    As prescribed
  • Drug: Sirolimus
    As prescribed
  • Experimental: 1
    Interventions:
    • Drug: mycophenolate mofetil [CellCept]
    • Drug: Corticosteroids
    • Drug: Sirolimus
  • Active Comparator: 2
    Interventions:
    • Drug: mycophenolate mofetil [CellCept]
    • Drug: Corticosteroids
    • Drug: Calcineurin inhibitors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
305
November 2009
November 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00121810
ML17140
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP