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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00658359
First received: April 9, 2008
Last updated: June 24, 2014
Last verified: June 2014
  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: 178
Study Start Date: August 2008
Estimated Study Completion Date: May 2015
Estimated 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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site Active, not recruiting
Los Angeles, California, United States, 90048
Pfizer Investigational Site Completed
Los Angeles, California, United States, 90095
Pfizer Investigational Site Active, not recruiting
Palo Alto, California, United States, 94304
Pfizer Investigational Site Active, not recruiting
Palo Alto, California, United States, 94305
Pfizer Investigational Site Active, not recruiting
San Diego, California, United States, 92123
Pfizer Investigational Site Active, not recruiting
San Francisco, California, United States, 94143
Pfizer Investigational Site Active, not recruiting
San Francisco, California, United States, 94115
United States, Colorado
Pfizer Investigational Site Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Pfizer Investigational Site Active, not recruiting
New Haven, Connecticut, United States, 06504
Pfizer Investigational Site Active, not recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
Pfizer Investigational Site Active, not recruiting
Gainesville, Florida, United States, 32610
Pfizer Investigational Site Active, not recruiting
Tampa, Florida, United States, 33606
United States, Illinois
Pfizer Investigational Site Active, not recruiting
Chicago, Illinois, United States, 60611
United States, Michigan
Pfizer Investigational Site Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Pfizer Investigational Site Active, not recruiting
Detroit, Michigan, United States, 48202
Pfizer Investigational Site Active, not recruiting
Flint, Michigan, United States, 48503
United States, Missouri
Pfizer Investigational Site Active, not recruiting
St. Louis, Missouri, United States, 63110
United States, North Carolina
Pfizer Investigational Site Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
Pfizer Investigational Site Active, not recruiting
Chapel Hill, North Carolina, United States, 27599-7211
Pfizer Investigational Site Active, not recruiting
Chapel Hill, North Carolina, United States, 27599-7360
Pfizer Investigational Site Active, not recruiting
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Pfizer Investigational Site Active, not recruiting
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
Pfizer Investigational Site Active, not recruiting
Charleston, South Carolina, United States, 29425
Pfizer Investigational Site Active, not recruiting
Charleston, South Carolina, United States, 29401
United States, Texas
Pfizer Investigational Site Active, not recruiting
Dallas, Texas, United States, 75246
Pfizer Investigational Site Active, not recruiting
Dallas, Texas, United States, 75204
Pfizer Investigational Site Active, not recruiting
Fort Worth, Texas, United States, 76104
Australia, New South Wales
Pfizer Investigational Site Active, not recruiting
Camperdown, New South Wales, Australia, 2050
Pfizer Investigational Site Active, not recruiting
Orange, New South Wales, Australia, 2800
Pfizer Investigational Site Active, not recruiting
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Pfizer Investigational Site Active, not recruiting
Adelaide, South Australia, Australia, 5000
Pfizer Investigational Site Active, not recruiting
Woodville, South Australia, Australia, 5011
Australia, Victoria
Pfizer Investigational Site Active, not recruiting
Parkville, Victoria, Australia, 3050
Belgium
Pfizer Investigational Site Active, not recruiting
Anderlecht, Belgium, 1070
Pfizer Investigational Site Active, not recruiting
Leuven, Belgium, 3000
Brazil
Pfizer Investigational Site Active, not recruiting
Porto Alegre, RS, Brazil, 90035-074
Pfizer Investigational Site Active, not recruiting
Sao Paulo, SP, Brazil, 04039-033
Pfizer Investigational Site Active, not recruiting
Sao Paulo, SP, Brazil, 04038-002
Canada, Alberta
Pfizer Investigational Site Active, not recruiting
Edmonton, Alberta, Canada, T6G 2B7
Czech Republic
Pfizer Investigational Site Active, not recruiting
Praha 4, Czech Republic, 140 21
France
Pfizer Investigational Site Active, not recruiting
Paris Cedex 15, France, 75743
Pfizer Investigational Site Active, not recruiting
Vandoeuvre Les Nancy, France, 54500
Germany
Pfizer Investigational Site Active, not recruiting
Berlin, Germany, 10117
Italy
Pfizer Investigational Site Active, not recruiting
Bologna, Italy, 40138
Pfizer Investigational Site Active, not recruiting
Roma, Italy, 00168
Korea, Republic of
Pfizer Investigational Site Completed
Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site Active, not recruiting
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site Active, not recruiting
Seoul, Korea, Republic of, 138-736
Netherlands
Pfizer Investigational Site Active, not recruiting
Rotterdam, Netherlands, 3015 GD
Pfizer Investigational Site Active, not recruiting
Rotterdam, Netherlands, 3015 CE
Norway
Pfizer Investigational Site Active, not recruiting
Oslo, Norway, 0424
Poland
Pfizer Investigational Site Recruiting
Wroclaw, Poland, 50-556
Pfizer Investigational Site Recruiting
Wroclaw, Poland, 50-417
Portugal
Pfizer Investigational Site Completed
Coimbra, Portugal, 3000-075
Pfizer Investigational Site Completed
Lisboa, Portugal, 1069-166
Spain
Pfizer Investigational Site Active, not recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Pfizer Investigational Site Active, not recruiting
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
Study First Received: April 9, 2008
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Immunosuppression
JAK3 inhibitor
kidney transplantation

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 23, 2014