Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00263328

Purpose

A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study A3921009, kidney transplant patients were given a JAK3 inhibitor or tacrolimus for 6 months posttransplant. Patients who responded well in study A3921009 were offered the opportunity to participate in study A3921021 which will extend the evaluation of safety and efficacy of CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects will continue to receive CP-690,550.

Condition	Intervention	Phase
Kidney Transplantation	Drug: Tacrolimus Drug: CP-690,550	Phase II

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Phase 2, Open-Label, Controlled, Extension Study For Stage 1 Subjects Of Study A3921009 To Evaluate The Long-Term Safety And Efficacy Of CP-690,550 Versus Tacrolimus, When Co-Administered With Mycophenolate Mofetil In Renal Allograft Recipients

Further study details as provided by Pfizer:

Primary Outcome Measures:

To evaluate the long-term safety of CP-690,550. [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the long-term efficacy of CP-690,550. [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	54
Study Start Date:	July 2005
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment group 1: Active Comparator Standard of care	Drug: Tacrolimus Standard of care
Treatment group 2: Experimental Treatment group 2 also receives mycophenolate mofetil	Drug: CP-690,550 CP-690,550 5 mg BID
Treatment group 3: Experimental	Drug: CP-690,550 CP-690,550 10 mg BID

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Enrollment in Stage 1 of Study A3921009 and have completed 6-months of treatment with trial medications (CP-690,550 or tacrolimus)
Recipient of a first-time kidney transplant

Exclusion Criteria:

Subject with any untreated condition that may affect drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
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: NCT00263328

Locations

United States, California
Pfizer Investigational Site
San Diego, California, United States, 92123
Pfizer Investigational Site
Palo Alto, California, United States, 94304
Pfizer Investigational Site
Los Angeles, California, United States, 90057
Pfizer Investigational Site
San Francisco, California, United States, 94115
Pfizer Investigational Site
San Francisco, California, United States, 94143
Pfizer Investigational Site
San Francisco, California, United States, 94143-0780
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80262
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10029
Pfizer Investigational Site
New York, New York, United States, 10021
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97210
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75204
Pfizer Investigational Site
Dallas, Texas, United States, 75246
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3921021
Study First Received:	December 6, 2005
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00263328
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

immunosuppression, JAK3 inhibitor, and kidney transplantation

Study placed in the following topic categories:

Mycophenolate mofetil
Tacrolimus

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009