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A Study Of CP-690,550 In Stable Kidney Transplant Patients

NCT ID: NCT01710033

Last Updated: 2012-12-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant

Keywords

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CP-690,550 kidney transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tables twice daily (BID) for 28 days

CP-690,550 5 mg BID

Group Type EXPERIMENTAL

CP-690,550 5 mg BID

Intervention Type DRUG

CP-690,550 5 mg BID for 28 days

CP-690,550 15 mg BID

Group Type EXPERIMENTAL

CP-690,550 15 mg BID

Intervention Type DRUG

CP-690,550 15 mg BID for 28 days

CP-690,550 30 mg BID

Group Type EXPERIMENTAL

CP-690,550 30 mg BID

Intervention Type DRUG

CP-690,550 30 mg BID for 28 days

Interventions

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Placebo

Placebo tables twice daily (BID) for 28 days

Intervention Type DRUG

CP-690,550 5 mg BID

CP-690,550 5 mg BID for 28 days

Intervention Type DRUG

CP-690,550 15 mg BID

CP-690,550 15 mg BID for 28 days

Intervention Type DRUG

CP-690,550 30 mg BID

CP-690,550 30 mg BID for 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Any rejection episodes in the preceding 3 months.
* Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Indianapolis, Indiana, United States

Site Status

Pfizer Investigational Site

Minneapolis, Minnesota, United States

Site Status

Pfizer Investigational Site

St Louis, Missouri, United States

Site Status

Pfizer Investigational Site

St Louis, Missouri, United States

Site Status

Pfizer Investigational Site

Livingston, New Jersey, United States

Site Status

Pfizer Investigational Site

Madison, Wisconsin, United States

Site Status

Pfizer Investigational Site

, ,

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921007&StudyName=A%20Study%20Of%20CP-690%2C550%20In%20Stable%20Kidney%20Transplant%20Patients

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Other Identifiers

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A3921007

Identifier Type: -

Identifier Source: org_study_id