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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Transplant

Intervention: Everolimus and tacrolimus (Drug); mycophenolate mofetil and tacrolimus (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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.

Clinical Details

Official title: A 12 Month, Multi-center, Randomized, Open-label Non-inferiority Study Comparing Safety and Efficacy of Concentration-controlled Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in de Novo Renal Transplant Recipients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Incidence of Composite Efficacy Failure

Secondary outcome:

Estimated Glomerular Filtration Rate (eGFR)

Number of Participants With Incidence of CMV (Viremia, Syndrome and Disease)

Number of Participants With Incidence Rates of BKV Viremia, BKV Viruria, or BKV Nephropathy

Number of Participants With Incidence of New Onset of Diabetes Mellitus

Number of Participants With Incidence of Proteinuria Events

Number of Participants With Incidence of Adverse Events, Serious Adverse Events, and Tacrolimus-associated Adverse Events

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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;

- 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.

Locations and Contacts

Novartis Investigative Site, Birmingham, Alabama 35233, United States

Novartis Investigative Site, Tucson, Arizona 85742-5022, United States

Novartis Investigative Site, Los Angeles, California 90033, United States

Novartis Investigative Site, Los Angeles, California 90048, United States

Novartis Investigative Site, Los Angeles, California 90095, United States

Novartis Investigative Site, Orange, California 92868, United States

Novartis Investigative Site, Sacramento, California 95817, United States

Novartis Investigative Site, San Diego, California 92103, United States

Novartis Investigative Site, San Diego, California 92123, United States

Novartis Investigative Site, San Francisco, California 94115, United States

Novartis Investigative Site, San Francisco, California 94143-0780, United States

Novartis Investigative Site, Aurora, Colorado 80045, United States

Novartis Investigative Site, Miami, Florida 33136, United States

Novartis Investigative Site, Orlando, Florida 32804, United States

Novartis Investigative Site, Tampa, Florida 33606, United States

Novartis Investigative Site, Chicago, Illinois 60637, United States

Novartis Investigative Site, Chicago, Illinois 60612, United States

Novartis Investigative Site, Baltimore, Maryland 21201, United States

Novartis Investigative Site, Boston, Massachusetts 02111, United States

Novartis Investigative Site, Worcester, Massachusetts 01655, United States

Novartis Investigative Site, Ann Arbor, Michigan 48109-0331, United States

Novartis Investigative Site, Detroit, Michigan 48202-2689, United States

Novartis Investigative Site, Detroit, Michigan 48236, United States

Novartis Investigative Site, Royal Oak, Michigan 48073, United States

Novartis Investigative Site, Minneapolis, Minnesota 55455, United States

Novartis Investigative Site, St. Louis, Missouri 63110, United States

Novartis Investigative Site, Omaha, Nebraska 68198-3285, United States

Novartis Investigative Site, Livingston, New Jersey 07039, United States

Novartis Investigative Site, Buffalo, New York 14215, United States

Novartis Investigative Site, New York, New York 10032, United States

Novartis Investigative Site, Durham, North Carolina 27710, United States

Novartis Investigative Site, Greenville, North Carolina 27834, United States

Novartis Investigative Site, Portland, Oregon 97239, United States

Novartis Investigative Site, Harrisburg, Pennsylvania 17105-8700, United States

Novartis Investigative Site, Montreal, Quebec H1T 2M4, Canada

Novartis Investigative Site, Montreal, Quebec H2L 4M1, Canada

Novartis Investigative Site, Charleston, South Carolina 29425, United States

Novartis Investigative Site, Nashville, Tennessee 37212-3139, United States

Novartis Investigative Site, Dallas, Texas 75246, United States

Novartis Investigative Site, Fort Worth, Texas 76104, United States

Novartis Investigative Site, Galveston, Texas 77555-0144, United States

Novartis Investigative Site, Houston, Texas 77030, United States

Novartis Investigative Site, Lubbock, Texas 79430, United States

Novartis Investigative Site, Salt Lake City, Utah 84132, United States

Novartis Investigative Site, Burlington, Vermont 05401, United States

Novartis Investigative Site, Charlottesville, Virginia 22908, United States

Novartis Investigative Site, Norfolk, Virginia 23507, United States

Novartis Investigative Site, Richmond, Virginia 23298, United States

Novartis Investigative Site, Seattle, Washington 98195, United States

Novartis Investigative Site, Spokane, Washington 99204, United States

Additional Information

Starting date: January 2010
Last updated: June 5, 2014

Page last updated: August 23, 2015

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