The study is undertaken to explore the safety of using Simulect at monthly dose intervals to
reduce the need of high dose/level CNI's such as Prograf.
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Full eligibility criteria for NCT00928811
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Male or female 18-75
First kidney transplant from a living or deceased donor
Receiving CNI and MPA
Able to tolerate full dose MPA
Calculated glomerular filtration rate >=30ml/min by Cockcroft-Gault equation
Able to tolerate renal graft biopsies
Provided written, informed consent
Females of childbearing potential must have a negative pregnancy test within 48 hours prior to the first Simulect administration
Known hypersensitivity to Simulect
Current preformed PRA>10%
Multi organ or second kidney transplant
Use of any investigational immunosuppressive drug within 1 month of inclusion
Female patients who are pregnant, lactating or of child bearing potential and not practicing two approved methods of birth control
Known malignancy or history of malignancy other than excised basal or squamous cell carcinoma of the skin
HBV, HCV, or HIV positive patients
Current severe infection
Receiving an organ from an extended criteria donor per United Network for Organ Sharing (UNOS) guidelines
Dialysis dependent one month post transplant
Live too far away from the transplant center for adequate follow up
All locations for NCT00928811
United States (1)
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
View full eligibility
Tris trial is registered with FDA with number: NCT00928811. The sponsor of the trial is Drexel University College of Medicine and it is looking for 5 volunteers for the current phase.
Official trial title: One-year Exploratory Study to Evaluate the Safety of Partial Replacement of CNI With Chronic Administration of Simulect in de Novo Normal-risk Kidney Transplant Recipients Treated With MPA
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