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Completed

NCT Number: NCT00121810

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bakersfield, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

mycophenolate mofetil [CellCept]

Drug

1.0-1.5 g oral dose twice daily

Corticosteroids

Drug

As prescribed

Calcineurin inhibitors

Drug

As prescribed

sirolimus

Drug

As prescribed

Primary outcomes

  1. Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 12

    Time frame: baseline to 12 months

    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 outcomes

  1. Mean Percent Change in Glomerular Filtration Rate From Baseline to Month 24

    Time frame: Baseline to 24 months

    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.

  2. Mean Percent Change in Serum Creatinine From Baseline to Months 6, 12, and 24

    Time frame: baseline, 6, 12, and 24 months

    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.

  3. Mean Percent Change in Calculated Creatinine Clearance From Baseline to Months 6, 12, and 24

    Time frame: baseline 6, 12, and 24 months

    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

  4. 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

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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®)

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Jul 21, 2005
Registry last updated
Apr 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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