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

End Stage Renal Disease Clinical Trial

Official 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

Clinical Trial 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.

Clinical Trial 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 abnormalities. The study consists of a run-in phase (1 month),and treatment phase (11 months) and safety assessment phase (1 month). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00928811
Study type Interventional
Source Drexel University
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date May 2009
Completion date April 2010
View Details
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