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

Completed · Phase 3

Conditions studied: Kidney Transplant

In brief

The purpose of this phase 3b study is to compare the safety and efficacy of everolimus with low dose tacrolimus to mycophenolate mofetil with standard dose tacrolimus in kidney transplant recipients.

Key facts

Study ID

NCT01025817

Run by

Novartis Pharmaceuticals

People needed

613

Starts

2010-01-01

Expected to finish

2013-03-01

Last updated by the study team

2015-11-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Donor organ with a cold ischemic time > 30 hours;
• Males or females who produce less than 100 ml of urine in the first 24 hours post-transplantation;
• Males or females who are recipients of ABO incompatible transplants, or T cell, or B cell crossmatch positive transplant;
• Males or females with severe total hypercholesterolemia or total hypertriglyceridemia (Patients on lipid lowering treatment with controlled hyperlipidemia are acceptable);
• Males or females 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.

Where it is running

• Novartis Investigative Site — Birmingham, Alabama, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Orange, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — San Francisco, California, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Worcester, Massachusetts, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — Royal Oak, Michigan, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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