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

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drexel University College of Medicine
• Collaborator: Novartis
• Treatments: Antibodies, Monoclonal; Basiliximab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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