Non-inferiority Study of the Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01025817
First received: November 19, 2009
Last updated: May 20, 2013
Last verified: May 2013

November 19, 2009
May 20, 2013
January 2010
March 2013   (final data collection date for primary outcome measure)
Composite efficacy failure rates demonstrated by treated biopsy proven acute rejection episodes (BPAR), graft loss, death, loss to follow-up [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01025817 on ClinicalTrials.gov Archive Site
  • To compare renal function outcome (GFR (glomerular filtration rate)) of everolimus with low dose tacrolimus regimen to that of CellCept® with standard dose tacrolimus regimen [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Incidence of CMV (viremia, syndrome and disease) and BKV (viremia, viruria, or nephropathy) [ Time Frame: Day 28 and Months 2, 3, 4, and 6 ] [ Designated as safety issue: No ]
  • Incidence of new onset diabetes mellitus defined as non-diabetic patients before transplantation, who are receiving glucose lowering treatment for more than 30 days post-transplant [ Time Frame: Days 1, 3, 5, 7, 14, and 28 and Months 2, 3, 4, 6, 7, 9, and 12 ] [ Designated as safety issue: No ]
  • Incidence of chronic kidney disease with associated proteinuria [ Time Frame: Days 1, 7, 14, and 28 and Months 2, 3, 4, 6, 7, 9, and 12 ] [ Designated as safety issue: No ]
  • Incidence of adverse events, serious adverse events, and tacrolimus-associated adverse events [ Time Frame: Days 1, 3, 4, 5, 7, 14, and 28 and Months 2, 3, 4, 6, 7, 9, and 12 ] [ Designated as safety issue: Yes ]
  • To compare renal function (GFR (glomerular filtration rate)) of everolimus with low dose tacrolimus regimen to that of CellCept® with standard dose tacrolimus regimen [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Incidence of CMV (viremia, syndrome and disease) and BKV (viremia, viruria, or nephropathy) [ Time Frame: Day 28 and Months 2, 3, 4, and 6 ] [ Designated as safety issue: No ]
  • Incidence of new onset diabetes mellitus defined as non-diabetic patients before transplantation, who are receiving glucose lowering treatment for more than 30 days post-transplant [ Time Frame: Days 1, 3, 5, 7, 14, and 28 and Months 2, 3, 4, 6, 7, 9, and 12 ] [ Designated as safety issue: No ]
  • Incidence of chronic kidney disease with associated proteinuria [ Time Frame: Days 1, 7, 14, and 28 and Months 2, 3, 4, 6, 7, 9, and 12 ] [ Designated as safety issue: No ]
  • Incidence of adverse events, serious adverse events, and tacrolimus-associated adverse events [ Time Frame: Days 1, 3, 4, 5, 7, 14, and 28 and Months 2, 3, 4, 6, 7, 9, and 12 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Non-inferiority Study of the Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Patients
A 12 Month, Multi-center, Randomized, Open-label Non-inferiority Study Comparing the Safety and Efficacy of Concentration-controlled Everolimus With Low Dose Tacrolimus to CellCept® (Mycophenolate Mofetil) With Standard Dose Tacrolimus in de Novo Renal Transplant Recipients

The purpose this study is to compare the safety and efficacy of everolimus with low dose tacrolimus to CellCept® (mycophenolate mofetil) with standard dose tacrolimus in kidney transplant patients.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplant
  • Drug: Everolimus and tacrolimus

    Everolimus:

    • Dosage form: 0.75 mg, 0.25 mg, and 0.5 mg tablets
    • Dose: 1.5 mg per day
    • Frequency: 0.75 mg twice daily

    Tacrolimus:

    • Dose adjusted to maintain specific blood levels
  • Drug: CellCept® and tacrolimus

    CellCept:

    • Dose form: 250mg capsule
    • Dose: 2g per day
    • Frequency: 1g twice daily

    Tacrolimus:

    • Dose adjusted to maintain specific blood levels
  • Experimental: Everolimus and low dose tacrolimus
    Intervention: Drug: Everolimus and tacrolimus
  • Active Comparator: CellCept® and standard dose tacrolimus
    Intervention: Drug: CellCept® and tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
613
March 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Male or female renal recipients 18-70 years of age undergoing kidney transplantation, either primary or re-transplant;
  • Recipient of a cadaveric, deceased donor (including expanded criteria donor organs and deceased donor organs after cardiac death), living unrelated or non-HLA identical living related donor kidney;
  • Graft must be functional (producing greater than or equal to 100 ml of urine within 24 hours after transplantation) at time of randomization.

Exclusion criteria:

  • Donor organ with a cold ischemic time > 30 hours;
  • Patients who produce less than 100 ml of urine in the first 24 hours post-transplantation;
  • Patients who are recipients of ABO incompatible transplants, or T cell, or B cell crossmatch positive transplant;
  • Patients with severe total hypercholesterolemia or total hypertriglyceridemia (Patients on lipid lowering treatment with controlled hyperlipidemia are acceptable);
  • Patients who have any surgical or any medical condition, such as severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus, which in the opinion of the investigator, might alter the absorption, distribution, metabolism and/or excretion of study medication.

Other protocol related inclusion/exclusion criteria may apply.

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01025817
CRAD001AUS92
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2013

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