Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00483756

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 this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.

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

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Randomized, Multicenter, Active Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Co-administration of CP-690,550 and Mycophenolate Mofetil / Mycophenolate Sodium in De Novo 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:

Measured glomerular filtration rate at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Clinical biopsy proven acute rejection rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measured glomerular filtration rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Pharmacokinetics of CP-690,550 and MPA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Health outcome measures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Safety and tolerability of combination regimens of CP-690,550 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Progression of chronic allograft lesions at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Lymphocyte subsets [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Efficacy of combination regimens of CP-690,550 at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	August 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Treatment Arm 1 will also receive standard of care medications	Drug: Cyclosporine Standard of care
2: Experimental Treatment Arm 2 will also receive standard of care medications	Drug: CP-690,550 CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12
3: Experimental Treatment Arm 3 will also receive standard of care medications	Drug: CP-690,550 CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12

Eligibility

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

Criteria

Inclusion Criteria:

Recipient of a first-time kidney transplant
Between the ages of 18 and 70 years, inclusive

Exclusion Criteria:

Recipient of any non-kidney transplant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483756

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 70 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 ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3921030
Study First Received:	June 6, 2007
Last Updated:	January 27, 2010
ClinicalTrials.gov Identifier:	NCT00483756 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Immunosuppression
JAK3 inhibitor
kidney transplantation.

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Cyclosporins

Immunosuppressive Agents
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 04, 2010