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

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.
ClinicalTrials.gov Identifier: NCT00658359
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : August 20, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Transplantation Drug: Cyclosporine Drug: CP-690,550 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
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
Study Start Date : August 2008
Primary Completion Date : March 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Long-term efficacy of CP-690,550 [ Time Frame: 6 years ]
  2. Long-term safety and tolerability of CP-690,550 [ Time Frame: 6 years ]

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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 Posted: April 15, 2008    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015

Keywords provided by Pfizer:
JAK3 inhibitor
kidney transplantation

Additional relevant MeSH terms:
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