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
  Purpose

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.


Condition Intervention Phase
Kidney Transplant
Drug: Everolimus and tacrolimus
Drug: CellCept® and tacrolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 613
Study Start Date: January 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Everolimus and low dose tacrolimus 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
Active Comparator: CellCept® and standard dose tacrolimus 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025817

  Hide Study Locations
Locations
United States, Alabama
Novartis Investigative Site
Birmingham, Alabama, United States, 35233
United States, Arizona
Novartis Investigative Site
Tucson, Arizona, United States, 85742-5022
United States, California
Novartis Investigative Site
Los Angeles, California, United States, 90095
Novartis Investigative Site
Los Angeles, California, United States, 90048
Novartis Investigative Site
Los Angeles, California, United States, 90033
Novartis Investigative Site
Orange, California, United States, 92868
Novartis Investigative Site
Sacramento, California, United States, 95817
Novartis Investigative Site
San Diego, California, United States, 92103
Novartis Investigative Site
San Diego, California, United States, 92123
Novartis Investigative Site
San Francisco, California, United States, 94115
Novartis Investigative Site
San Francisco, California, United States, 94143-0780
United States, Colorado
Novartis Investigative Site
Aurora, Colorado, United States, 80045
United States, Florida
Novartis Investigative Site
Miami, Florida, United States, 33136
Novartis Investigative Site
Orlando, Florida, United States, 32804
Novartis Investigative Site
Tampa, Florida, United States, 33606
United States, Illinois
Novartis Investigative Site
Chicago, Illinois, United States, 60612
Novartis Investigative Site
Chicago, Illinois, United States, 60637
United States, Maryland
Novartis Investigative Site
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02111
Novartis Investigative Site
Worcester, Massachusetts, United States, 01655
United States, Michigan
Novartis Investigative Site
Ann Arbor, Michigan, United States, 48109-0331
Novartis Investigative Site
Detroit, Michigan, United States, 48236
Novartis Investigative Site
Detroit, Michigan, United States, 48202-2689
Novartis Investigative Site
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Novartis Investigative Site
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Novartis Investigative Site
St. Louis, Missouri, United States, 63110
United States, Nebraska
Novartis Investigative Site
Omaha, Nebraska, United States, 68198-3285
United States, New Jersey
Novartis Investigative Site
Livingston, New Jersey, United States, 07039
United States, New York
Novartis Investigative Site
Buffalo, New York, United States, 14215
Novartis Investigative Site
New York, New York, United States, 10032
United States, North Carolina
Novartis Investigative Site
Durham, North Carolina, United States, 27710
Novartis Investigative Site
Greenville, North Carolina, United States, 27834
United States, Oregon
Novartis Investigative Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Novartis Investigative Site
Harrisburg, Pennsylvania, United States, 17105-8700
United States, South Carolina
Novartis Investigative Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
Novartis Investigative Site
Nashville, Tennessee, United States, 37212-3139
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75246
Novartis Investigative Site
Fort Worth, Texas, United States, 76104
Novartis Investigative Site
Galveston, Texas, United States, 77555-0144
Novartis Investigative Site
Houston, Texas, United States, 77030
Novartis Investigative Site
Lubbock, Texas, United States, 79430
United States, Utah
Novartis Investigative Site
Salt Lake City, Utah, United States, 84132
United States, Vermont
Novartis Investigative Site
Burlington, Vermont, United States, 05401
United States, Virginia
Novartis Investigative Site
Charlottesville, Virginia, United States, 22908
Novartis Investigative Site
Norfolk, Virginia, United States, 23507
Novartis Investigative Site
Richmond, Virginia, United States, 23298
United States, Washington
Novartis Investigative Site
Seattle, Washington, United States, 98195
Novartis Investigative Site
Spokane, Washington, United States, 99204
Canada, Alberta
Novartis Investigative Site
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 2M4
Novartis Investigative Site
Montreal, Quebec, Canada, H2L 4M1
Canada
Novartis Investigative Site
Saskatchewan, Canada, S7K 0M7
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01025817     History of Changes
Other Study ID Numbers: CRAD001AUS92
Study First Received: November 19, 2009
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Novartis:
Kidney transplant
renal transplant
immunosuppression
mycophenolate mofetil
tacrolimus
everolimus

Additional relevant MeSH terms:
Mycophenolate mofetil
Everolimus
Sirolimus
Tacrolimus
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