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



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 70
Updated:4/21/2016
Start Date:January 2010
End Date:March 2013

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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

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.


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.
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43
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Galveston, Texas 77555
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Ann Arbor, Michigan 48109
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Aurora, Colorado 80010
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Baltimore, Maryland 21287
356
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Birmingham, Alabama 35209
1051
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Boston, Massachusetts 02118
2
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Boston, MA
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Buffalo, New York 14215
393
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Burlington, Vermont 05401
180
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Burlington, VT
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Charleston, South Carolina 29407
818
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Charlottesville, Virginia 22904
491
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Chicago, Illinois 60612
849
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Dallas, Texas 75216
1549
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Detroit, Michigan 48202
610
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Durham, North Carolina 27710
607
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Fort Worth, Texas 76104
1574
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Greenville, North Carolina 27834
574
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Harrisburg, Pennsylvania 17105
332
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Harrisburg, PA
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Houston, Texas 77030
1605
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Houston, TX
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Livingston, New Jersey 07039
199
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Livingston, NJ
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Los Angeles, California 90095
2599
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Los Angeles, CA
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Lubbock, Texas 79410
1772
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Miami, Florida 33136
1256
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Miami, FL
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Minneapolis, Minnesota 55402
1118
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Montreal, Quebec
248
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Montreal,
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Nashville, Tennessee 37205
946
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
180
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Norfolk, Virginia 23507
470
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Norfolk, VA
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Omaha, Nebraska 68144
1285
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Orange, California 92868
2576
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Orlando, Florida 32806
1115
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Orlando, FL
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Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Portland, OR
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Richmond, Virginia 23249
476
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Royal Oak, Michigan 48073
614
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Sacramento, California 95825
2617
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Salt Lake City, Utah 84103
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San Diego, California 92123
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San Francisco, California 94121
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Seattle, Washington 98103
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Spokane, Washington 99202
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St. Louis, Missouri 63110
1036
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Tampa, Florida 33613
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Tucson, Arizona 85745
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Worcester, Massachusetts 01665
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Worcester, MA
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