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

Completed · Phase 4

Conditions studied: End Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy, Renal Transplantation

In brief

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.

Key facts

Study ID

NCT01950819

Run by

Novartis Pharmaceuticals

People needed

2037

Starts

2013-12-03

Expected to finish

2018-01-17

Last updated by the study team

2019-01-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent obtained.
• Subject randomized within 24 hr of completion of transplant surgery.
• Recipient of a kidney with a cold ischemia time < 30 hours.
• 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.

You may not qualify if…

• Subject unable to tolerate oral medication at time of randomization.
• Use of other investigational drugs at the time of enrollment.
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
• Multi-organ transplant recipient.
• Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.
• 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.
• Subject who is HIV-positive.
• 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.
• 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).
• Subject with a BMI greater than 35.
• Subject with severe systemic infections, current or within the two weeks prior to randomization.
• Subject requiring systemic anticoagulation.
• History of malignancy of any organ system.
• Subject with severe restrictive or obstructive pulmonary disorders.
• Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled.
• Subject with white blood cell (WBC) count ≤ 2,000 /mm3 or with platelet count ≤ 50,000 /mm3.
• Pregnant or nursing (lactating) women.
• 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.

Where it is running

• Novartis Investigative Site — Loma Linda, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Sacramento, 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 — Denver, Colorado, 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 — Boston, Massachusetts, United States
• Novartis Investigative Site — Burlington, Massachusetts, United States
• Novartis Investigative Site — Ann Arbor, Michigan, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Livingston, New Jersey, United States
• Novartis Investigative Site — Buffalo, New York, United States
• Novartis Investigative Site — The Bronx, New York, United States
• Novartis Investigative Site — Chapel Hill, North Carolina, United States
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Winston-Salem, North Carolina, United States
• Novartis Investigative Site — Cleveland, Ohio, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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