At a glance
ClinicalIndex Comparison Record- ✓Recipient of a first-time kidney transplant
- ✓Age 18 to 70 years, inclusive
- ✕Recipient of any non-kidney transplant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 6-Month, Phase 2, Multicenter, Randomized, Open-Label, Comparative Study Of 2 Dose Levels Of CP-690,550 Administered Concomitantly With IL-2 Receptor Antagonist Induction Therapy, Mycophenolate Mofetil And Corticosteroids Versus A Tacrolimus-Based Immunosuppressive Regimen For The Prevention Of Allograft Rejection In De Novo Renal Allograft Recipients
In Brief
A Phase 2 clinical trial evaluating CP-690,550 and tacrolimus for Kidney Transplantation. Completed, enrolled 61 participants across 20 sites.
Detailed Summary
This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.
Study Details
Timeline
Interventions
15 mg twice daily
30 mg twice daily
dose adjusted according to level