Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients

NCT ID: NCT00658359

Last Updated: 2018-02-23

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

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2015-06-30

Brief Summary

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This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.

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 Arm 1

Treatment Arm 1 will also receive standard of care medications

Group Type ACTIVE_COMPARATOR

Cyclosporine

Intervention Type DRUG

Standard of care

Treatment Arm 2

Treatment Arm 2 will also receive standard of care medications

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

CP-690,550 tablets dosed BID Months 12-72

Treatment Arm 3

Treatment Arm 3 will also receive standard of care medications

Group Type EXPERIMENTAL

CP-690,550

Intervention Type DRUG

CP-690,550 tablets dosed BID Months 12-72

Interventions

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Cyclosporine

Standard of care

Intervention Type DRUG

CP-690,550

CP-690,550 tablets dosed BID Months 12-72

Intervention Type DRUG

CP-690,550

CP-690,550 tablets dosed BID Months 12-72

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who successfully completed Study A3921030

Exclusion Criteria

* 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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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Cedars-Sinai MedicalCenter

Los Angeles, California, United States

Site Status

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

UCLA Medical Center

Los Angeles, California, United States

Site Status

Stanford School of Medicine

Palo Alto, California, United States

Site Status

Stanford University Medical Center

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 - Pacific Campus

San Francisco, California, United States

Site Status

California Pacific Medical Center

San Francisco, California, United States

Site Status

UCSF Medical Center - Long Hospital

San Francisco, California, United States

Site Status

USCF Medical Center - Connie Frank Transplant Center

San Francisco, California, United States

Site Status

University of Colorado Denver

Aurora, Colorado, United States

Site Status

Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Yale Physicians Building

New Haven, Connecticut, United States

Site Status

University Of Florida

Gainesville, Florida, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

NUCATS's Clinical Research Unit

Chicago, Illinois, United States

Site Status

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Investigational Drug Services (IDS) / UNC Healthcare

Chapel Hill, North Carolina, United States

Site Status

Transplant Clinic/UNC Heathcare

Chapel Hill, North Carolina, United States

Site Status

UNC Department of Surgery, Clinical Trials Consortium

Chapel Hill, North Carolina, United States

Site Status

UNC Department of Surgery/Abdominal Transplant Division

Chapel Hill, North Carolina, United States

Site Status

Division of Pharmacotherapy, School of Pharmacy, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

University of North Carolina, Department of Medicine/Nephrology

Chapel Hill, North Carolina, United States

Site Status

Drexel University College of Medicine - Hahnemann University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Hahnemann University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina, Department of Transplantation Surgery

Charleston, South Carolina, United States

Site Status

Nephrology Clinic

Charleston, South Carolina, United States

Site Status

Dallas Transplant Institute

Dallas, Texas, United States

Site Status

Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center

Dallas, Texas, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status

Westmead Hospital, Department of Renal Medicine

Westmead, New South Wales, Australia

Site Status

Central Northern Adelaide Renal and Transplantation Service

Adelaide, South Australia, Australia

Site Status

The Queen Elizabeth Hospital

Woodville, South Australia, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Hopital Erasme

Anderlecht, Brussels Capital, Belgium

Site Status

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, , Belgium

Site Status

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital do Rim e Hipertensao

São Paulo, São Paulo, Brazil

Site Status

Ambulatorio Pos Transplante do Hospital do Rim a Hipertensao

São Paulo, São Paulo, Brazil

Site Status

Hospital do Rim e Hipertensao

São Paulo, , Brazil

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Institut Klinicke a Experimentalni Mediciny

Praha 4 Krc, , Czechia

Site Status

Hopital Necker

Paris, , France

Site Status

CHRU de Nancy-Brabois - Service de Nephrologie

Vandœuvre-lès-Nancy, , France

Site Status

Charite - Universitatsmedizin Berlin

Berlin, , Germany

Site Status

Istituto di Clinica Chirurgica, Universita Cattolica del Sacro Cuore

Roma, RM, Italy

Site Status

Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi

Bologna, , Italy

Site Status

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Site Status

Oslo universitetssykehus HF- Rikshospitalet

Oslo, , Norway

Site Status

Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego we Wroclawiu

Wroclaw, , Poland

Site Status

Hospitais da Universidade de Coimbra, EPE

Coimbra, , Portugal

Site Status

Hospital Curry Cabral

Lisbon, , Portugal

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Department of Surgery, Yonsei University College of Medicine Severance Hospital

Seoul, , South Korea

Site Status

Asan Medical Center, Department of Surgery

Seoul, , South Korea

Site Status

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Site Status

Countries

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United States Australia Belgium Brazil Canada Czechia France Germany Italy Netherlands Norway Poland Portugal South Korea Spain

Related Links

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Other Identifiers

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2008-002345-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A3921050

Identifier Type: -

Identifier Source: org_study_id

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