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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: April 9, 2008
Last updated: August 18, 2015
Last verified: August 2015
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 ]

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


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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

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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 
Study First Received: April 9, 2008
Last Updated: August 18, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
JAK3 inhibitor
kidney transplantation

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

ClinicalTrials.gov processed this record on May 26, 2016