CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
CP-690,550 5 mg BIDfrom 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.

Search/NCT01710033
NCT01710033Phase 1Completed
CompareCT.gov

Phase 1, Placebo-controlled, Randomized, Sequential, Parallel-group, Dose Escalation Study to Evaluate 28-day Multiple Dose Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CP-690,550 in Stable Renal Allograft Recipients

Pfizer·interventional·Posted Oct 18, 2012·Updated Dec 26, 2012

In Brief

A Phase 1 clinical trial evaluating Placebo, CP-690,550 5 mg BID, and 2 other interventions for Kidney Transplant. Completed, enrolled 28 participants across 11 sites.

Detailed Summary

This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplant
Countries, United States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2012
Enrollment StartSep 1, 2003
Primary CompletionApr 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.7 years ago

Interventions

Placebodrug

Placebo tables twice daily (BID) for 28 days

CP-690,550 5 mg BIDdrug

CP-690,550 5 mg BID for 28 days

CP-690,550 15 mg BIDdrug

CP-690,550 15 mg BID for 28 days

CP-690,550 30 mg BIDdrug

CP-690,550 30 mg BID for 28 days