A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients

NCT ID: NCT00106639

Last Updated: 2013-03-12

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

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CP-690,550 15 mg BID

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

15 mg twice daily

CP-690,550 30 mg BID

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

30 mg twice daily

tacrolimus

Group Type ACTIVE_COMPARATOR

tacrolimus

Intervention Type DRUG

dose adjusted according to level

Interventions

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CP-690,550

15 mg twice daily

Intervention Type DRUG

CP-690,550

30 mg twice daily

Intervention Type DRUG

tacrolimus

dose adjusted according to level

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Recipient of a first-time kidney transplant
* Between the ages of 18 and 70 years, inclusive

Exclusion Criteria

* Recipient of any non-kidney transplant
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

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Palo Alto, California, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status

Pfizer Investigational Site

San Francisco, California, United States

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Pfizer Investigational Site

San Francisco, California, United States

Site Status

Pfizer Investigational Site

Stanford, California, United States

Site Status

Pfizer Investigational Site

Denver, Colorado, United States

Site Status

Pfizer Investigational Site

Chicago, Illinois, United States

Site Status

Pfizer Investigational Site

New Orleans, Louisiana, 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

New York, New York, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

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Pfizer Investigational Site

Portland, Oregon, United States

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Pfizer Investigational Site

Dallas, Texas, United States

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Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

Richmond, Virginia, United States

Site Status

Pfizer Investigational Site

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Busque S, Leventhal J, Brennan DC, Steinberg S, Klintmalm G, Shah T, Mulgaonkar S, Bromberg JS, Vincenti F, Hariharan S, Slakey D, Peddi VR, Fisher RA, Lawendy N, Wang C, Chan G. Calcineurin-inhibitor-free immunosuppression based on the JAK inhibitor CP-690,550: a pilot study in de novo kidney allograft recipients. Am J Transplant. 2009 Aug;9(8):1936-45. doi: 10.1111/j.1600-6143.2009.02720.x.

Reference Type DERIVED
PMID: 19660021 (View on PubMed)

Related Links

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Other Identifiers

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A3921009

Identifier Type: -

Identifier Source: org_study_id

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