Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:December 3, 2013
End Date:January 17, 2018

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A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft
function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal
transplant recipients.


Inclusion Criteria:

1. Written informed consent obtained.

2. Subject randomized within 24 hr of completion of transplant surgery.

3. Recipient of a kidney with a cold ischemia time < 30 hours.

4. Recipient of a primary (or secondary, if first graft is not lost due to immunological
reasons) renal transplant from a deceased heart beating, living unrelated, living
related non-human leukocyte antigen identical or an expanded criteria donor.

Exclusion Criteria:

1. Subject unable to tolerate oral medication at time of randomization.

2. Use of other investigational drugs at the time of enrollment.

3. History of hypersensitivity to any of the study drugs or to drugs of similar chemical
classes.

4. Multi-organ transplant recipient.

5. Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC)
crossmatch positive transplant.

6. Subject at high immunological risk for rejection as determined by local practice for
assessment of anti-donor reactivity e.g. high PRA, presence of pre-existing DSA.

7. Subject who is HIV-positive.

8. HBsAg and/or a HCV positive subject with evidence of elevated LFTs (ALT/AST levels ≥
2.5 times ULN). Viral serology results obtained within 6 months prior to randomization
are acceptable.

9. Recipient of a kidney from a donor who tests positive for human immunodeficiency virus
(HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV).

10. Subject with a BMI greater than 35.

11. Subject with severe systemic infections, current or within the two weeks prior to
randomization.

12. Subject requiring systemic anticoagulation.

13. History of malignancy of any organ system.

14. Subject with severe restrictive or obstructive pulmonary disorders.

15. Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be
controlled.

16. Subject with white blood cell (WBC) count ≤ 2,000 /mm3 or with platelet count ≤ 50,000
/mm3.

17. Pregnant or nursing (lactating) women.

18. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using effective methods of contraception during
dosing of study treatment.
We found this trial at
43
sites
Ann Arbor, Michigan 48109
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Aurora, Colorado 80010
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Aurora, CO
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Baltimore, Maryland 21287
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Baltimore, MD
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Birmingham, Alabama 35209
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Birmingham, AL
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Boston, Massachusetts 02118
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Boston, MA
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Boston, Massachusetts 02118
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Boston, MA
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Boston, Massachusetts 02118
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Boston, MA
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Bronx, New York 10461
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Bronx, NY
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Buffalo, New York 14215
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Buffalo, NY
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Burlington, Massachusetts 01805
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Burlington, MA
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Caba, Buenos Aires
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Caba,
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Chapel Hill, North Carolina 27599
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Chapel Hill, NC
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Charleston, South Carolina 29407
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Charleston, SC
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Charlottesville, Virginia 22904
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Charlottesville, VA
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Chicago, Illinois 60612
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Chicago, IL
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Cleveland, Ohio 44109
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Cleveland, OH
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Cleveland, Ohio 44109
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Cleveland, OH
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Columbus, Ohio 43205
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Columbus, OH
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Dallas, Texas 75216
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Dallas, TX
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Denver, Colorado 80262
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Denver, CO
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Detroit, Michigan 48202
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Detroit, MI
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Durham, North Carolina 27710
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Durham, NC
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Fort Worth, Texas 76104
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Fort Worth, TX
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Harrisburg, Pennsylvania 17105
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Harrisburg, PA
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Livingston, New Jersey 07039
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Livingston, NJ
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Loma Linda, California 92354
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Loma Linda, CA
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Los Angeles, California 90095
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Los Angeles, California 90095
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Los Angeles, California 90095
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Madison, Wisconsin 53705
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Madison, WI
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Milwaukee, Wisconsin 53209
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Milwaukee, WI
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Nashville, Tennessee 37205
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Nashville, TN
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Providence, Rhode Island 02908
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Providence, RI
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Sacramento, California 95825
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Sacramento, CA
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Saint Louis, Missouri 63128
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Saint Louis, MO
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Salt Lake City, Utah 84103
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Salt Lake City, UT
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San Diego, California 92123
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San Diego, CA
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San Francisco, California 94121
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San Francisco, CA
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San Francisco, California 94121
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Seattle, Washington 98103
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Seattle, WA
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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