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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00658359
First received: April 9, 2008
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: Cyclosporine
Drug: CP-690,550
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 2, Multicenter, Open-label, Active Comparator-controlled, Extension Trial To Evaluate The Long-term Safety And Efficacy Of Cp-690,550 In Renal Allograft Recipients

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Long-term efficacy of CP-690,550 [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Long-term safety and tolerability of CP-690,550 [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Additional measures of efficacy of CP-690,550 [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Effects of CP-690,550 on health outcome assessments [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Relationship of CP-690,550 concentration and safety/efficacy endpoints [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: August 2008
Estimated Study Completion Date: July 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Arm 1
Treatment Arm 1 will also receive standard of care medications
Drug: Cyclosporine
Standard of care
Experimental: Treatment Arm 2
Treatment Arm 2 will also receive standard of care medications
Drug: CP-690,550
CP-690,550 tablets dosed BID Months 12-72
Experimental: Treatment Arm 3
Treatment Arm 3 will also receive standard of care medications
Drug: CP-690,550
CP-690,550 tablets dosed BID Months 12-72

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658359

  Hide Study Locations
Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
UCLA Kidney Transplant Research
Los Angeles, California, United States, 90024
UCLA Kidney Transplant Research
Los Angeles, California, United States, 90095
Stanford School of Medicine
Palo Alto, California, United States, 94304
Stanford University Medical Center
Palo Alto, California, United States, 94304
Stanford University Medical Center
Palo Alto, California, United States, 94305
Sharp Memorial Hospital
San Diego, California, United States, 92123
Balboa Institute of Transplantation
San diego, California, United States, 92123
California Pacific Medical Center
San Francisco, California, United States, 94115
UCSF Medical Center
San Francisco, California, United States, 94143
University of California San Francisco
San Francisco, California, United States, 94143
University of California, Sanfrancisco
San Francisco, California, United States, 94143-0780
United States, Colorado
Renal Division Clinical Trials Office - drug storage
Aurora, Colorado, United States, 80045
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06504
United States, Florida
Investigational Drug Services
Gainesville, Florida, United States, 32610
University of Florida
Gainesville, Florida, United States, 32610
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Illinois
NUCATS's Clinical Research Unit
Chicago, Illinois, United States, 60611
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Hurley Medical Center
Flint, Michigan, United States, 48503
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, North Carolina
University of North Carolina, Department of Medicine/Nephrology
Chapel Hill, North Carolina, United States, 27599
Division of Pharmacotherapy
Chapel Hill, North Carolina, United States, 27599-7360
Investigational Drug Services (IDS) / UNC Healthcare
Chapel Hill, North Carolina, United States, 27514
Transplant Clinic / UNC Healthcare
Chapel Hill, North Carolina, United States, 27514
UNC Department of Sugery/Adominal Transplant Division
Chapel Hill, North Carolina, United States, 27599-7211
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
Drug Shipment Address Medical University of South Carolina-Investigational Drug Services
Charleston, South Carolina, United States, 29425
Medical University of South Carolina, Department of Transplantation Surgery
Charleston, South Carolina, United States, 29425
Nephrology Clinic
Charleston, South Carolina, United States, 29425
United States, Texas
Annette C. and Harold C. Simmons Transplant Institute at Baylor University Medical Center
Dallas, Texas, United States, 75246
Baylor University Medical Center
Dallas, Texas, United States, 75246
Dallas Transplant Insitute
Dallas, Texas, United States, 75204
Australia, New South Wales
Royal Prince Alfred Hospital, Transplant Ambulatory Care
Camperdown, New South Wales, Australia, 2050
Orange Base Hospital
Orange, New South Wales, Australia, 2800
Westmead Hospital, Department of Renal Medicine
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Central Northern Adelaide Renal and Transplantation Service
Adelaide, South Australia, Australia, 5000
The Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Hopital Erasme / Nephrologie
Anderlecht, Belgium, 1070
Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, RS, Brazil, 90020-090
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, RS, Brazil, 90035-074
Ambulatorio Pos Transplante do Hospital do Rim a Hipertensao
Sao Paulo, SP, Brazil, 04039-033
Hospital do Rim e Hipertensao
Sao Paulo, SP, Brazil, 04038-002
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Czech Republic
Institut Klinicke a Experimentalni Mediciny
Praha 4, Czech Republic, 140 21
France
Hopital Necker
Paris Cedex 15, France, 75743
CHRU de Nancy-Brabois - Service de Nephrologie
Vandoeuvre Les Nancy, France, 54500
Germany
Centrum 13 Medizinische Klinik
Berlin, Germany, 10117
Italy
Unita' Operativa di Nefrologia Dialisi e Trapianti, Azienda Ospedaliero Universitaria di Bologna
Bologna, BO, Italy, 40138
Istituto di Clinica Chirurgica, Universita Cattolica del Sacro Cuore
Roma, RM, Italy, 00168
A.O.U di Bologna - Policlinico S. Orsola Malpighi
Bologna, Italy, 40138
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Department of Surgery, Yonsei University College of Medicine Severance Hospital
Seoul, Korea, Republic of, 120-752
Asan Medical Center, Department of Surgery
Seoul, Korea, Republic of, 138-736
Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Norway
Oslo universitetssykehus HF- Rikshospitalet, Medisinsk avdeling
Oslo, Norway, 0372
Poland
Akademicki Szpital Kliniczny im. J. Mikulicza-Radeckiego
Wroclaw, Poland, 50-556
Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego we Wroclawiu
Wroclaw, Poland, 50-556
Portugal
Hospitais da Universidade de Coimbra EPE
Coimbra, Portugal, 3000-075
Hospital Curry Cabral
Lisboa, Portugal, 1069-166
Spain
Hospital Universitari de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Clinic I Provincial de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00658359     History of Changes
Other Study ID Numbers: A3921050, 2008-002345-23
Study First Received: April 9, 2008
Last Updated: May 11, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Immunosuppression
JAK3 inhibitor
kidney transplantation

Additional relevant MeSH terms:
Tofacitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on July 26, 2015