At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 334 enrolled
Drug / intervention
Voclosporin +1 moredrug
Likely dose
Voclosporin 0.8 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIb, Randomized, Multicenter, Open-Label, Concentration Controlled, Safety Study of ISA247 (Voclosporin) and Tacrolimus (Prograf®) in De Novo Renal Transplant Patients
In Brief
A Phase 2 clinical trial evaluating Voclosporin and tacrolimus for Kidney Diseases. Completed, enrolled 334 participants across 45 sites in 2 countries.
Detailed Summary
This study will see if voclosporin is safe and effective in preventing kidney transplant rejection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Diseases
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2005
Enrollment StartJan 2006
Primary CompletionJul 2009
TodayJul 2026
First PostedDec 28, 2005
Enrollment StartJan 1, 2006
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.5 years ago
Interventions
Voclosporindrug
voclosporin 0.4, 0.6, 0.8 mg/kg po BID
tacrolimusdrug
tacrolimus 0.05 mg/kg po BID