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Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient

NCT ID: NCT00263328

Last Updated: 2015-07-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2014-06-30

Brief Summary

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A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months posttransplant. Patients who completed study A3921009 were offered the opportunity to participate in study A3921021 which will extend the evaluation of safety and efficacy of CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be discontinued.

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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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Treatment group 1

Standard of care

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

Standard of care

Treatment group 2

Treatment group 2 also receives mycophenolate mofetil

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

CP-690,550 5 mg BID

Treatment group 3

Treatment group 3 does not receive mycophenolate mofetil

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

CP-690,550 10 mg BID

Interventions

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Tacrolimus

Standard of care

Intervention Type DRUG

CP-690,550

CP-690,550 5 mg BID

Intervention Type DRUG

CP-690,550

CP-690,550 10 mg BID

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Enrollment in Stage 1 of Study A3921009 and have completed 6-months of treatment with trial medications (CP-690,550 or tacrolimus)
* Recipient of a first-time kidney transplant

Exclusion Criteria

* Subject with any untreated condition that may affect drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
* Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants.
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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Multi Organ Transplant Center

Los Angeles, California, United States

Site Status

St. Vincent Medical Center

Los Angeles, California, United States

Site Status

Transplant Research Institute

Los Angeles, California, United States

Site Status

Stanford School of Medicine

Palo Alto, California, United States

Site Status

Balboa Institute of Transplantation

San Diego, California, United States

Site Status

California Institute of Renal Research

San Diego, California, United States

Site Status

Sharp Memorial Hospital

San Diego, California, United States

Site Status

California Pacific Medical Center

San Francisco, California, United States

Site Status

University of California, San Francisco, Kidney Transplant Unit

San Francisco, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

University of Colorado Health Sciences Center Renal Clinical Trials Office

Aurora, Colorado, United States

Site Status

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Northwestern University-Feinberg School of Medicine, Division of Organ Transplantation

Chicago, Illinois, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Jack J Dreyfus Clinic

New York, New York, United States

Site Status

Recanati/Miller Transplantation Institute

New York, New York, United States

Site Status

New York Presbyterian Hospital / Weill Cornell Medical Center

New York, New York, United States

Site Status

Legacy Good Samaritan Hospital

Portland, Oregon, United States

Site Status

Legacy Transplant Services

Portland, Oregon, United States

Site Status

Northwest Renal Clinic

Portland, Oregon, United States

Site Status

Dallas Transplant Institute

Dallas, Texas, United States

Site Status

Annette C & Harold C Simmons Transplant Institute

Dallas, Texas, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

Baylor All Saints Medical Center

Fort Worth, Texas, United States

Site Status

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States

Site Status

Medical College of Wisconsin

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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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921021&StudyName=Extension%20Study%20Of%20Stage%201%20Subjects%20Of%20Study%20A3921009%20For%20The%20Prevention%20Of%20Acute%20Rejection%20In%20Kidney%20Transplant%20Patient

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3921021

Identifier Type: -

Identifier Source: org_study_id

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