Status:
TERMINATED
Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant
Lead Sponsor:
Drexel University College of Medicine
Collaborating Sponsors:
Novartis
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
The use of CNI's after kidney transplantation is associated with typical adverse effects such as potential contribution to progressive impairment of renal function, hypertension, and metabolic abnorma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00928811
Start Date
May 1 2009
End Date
April 1 2010
Last Update
February 10 2015
Active Locations (1)
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1
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102