Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00658359

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 II

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:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

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

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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 54 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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:	January 3, 2012
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 February 09, 2012