A Study Of CP-690,550 In Stable Kidney Transplant Patients
Completed · Phase 1 · Has a placebo group
Conditions studied: Kidney Transplant
In brief
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.
Key facts
- Study ID
- NCT01710033
- Run by
- Pfizer
- People needed
- 28
- Starts
- 2003-09-01
- Expected to finish
- 2005-04-01
- Last updated by the study team
- 2012-12-26
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Medically stable kidney transplant patients 6 or more months after transplantation.
- Subjects must be on mycophenolate mofetil 1-2 gm daily
- In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2, subjects must be on a calcineurin inhibitor-free regimen.
You may not qualify if…
- Any rejection episodes in the preceding 3 months.
- Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.
Where it is running
- Pfizer Investigational Site — Birmingham, Alabama, United States
- Pfizer Investigational Site — Birmingham, Alabama, United States
- Pfizer Investigational Site — Birmingham, Alabama, United States
- Pfizer Investigational Site — Los Angeles, California, United States
- Pfizer Investigational Site — Indianapolis, Indiana, United States
- Pfizer Investigational Site — Minneapolis, Minnesota, United States
- Pfizer Investigational Site — St Louis, Missouri, United States
- Pfizer Investigational Site — St Louis, Missouri, United States
- Pfizer Investigational Site — Livingston, New Jersey, United States
- Pfizer Investigational Site — Madison, Wisconsin, United States
- Pfizer Investigational Site —
Full record on ClinicalTrials.gov
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