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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00658359
First Posted: April 15, 2008
Last Update Posted: August 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • Long-term safety and tolerability of CP-690,550 [ Time Frame: 6 years ]

Secondary Outcome Measures:
  • Additional measures of efficacy of CP-690,550 [ Time Frame: 6 years ]
  • Effects of CP-690,550 on health outcome assessments [ Time Frame: 3 years ]
  • Relationship of CP-690,550 concentration and safety/efficacy endpoints [ Time Frame: 6 years ]

Enrollment: 178
Study Start Date: August 2008
Study Completion Date: June 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658359


  Show 70 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00658359     History of Changes
Other Study ID Numbers: A3921050
2008-002345-23 ( EudraCT Number )
First Submitted: April 9, 2008
First Posted: April 15, 2008
Last Update Posted: August 20, 2015
Last Verified: August 2015

Keywords provided by Pfizer:
Immunosuppression
JAK3 inhibitor
kidney transplantation

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Tofacitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Protein Kinase Inhibitors