Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant

Stopped early · Phase 2/Phase 3

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT00928811

Run by

Drexel University College of Medicine

People needed

5

Starts

2009-05-01

Expected to finish

2010-04-01

Last updated by the study team

2015-02-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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