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

  Show 36 Study Locations
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 April 17, 2014