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Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00556257
First received: November 8, 2007
Last updated: May 27, 2008
Last verified: May 2008
History of Changes
  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 in addition to other standard transplant medications such as prednisone.


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 Pilot Randomized, Multicenter, Open-Label, Active Comparator-Controlled Trial Of A CP-690,550-Based Regimen In De Novo Kidney Allograft Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical biopsy proven acute rejection rate at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of CP-690,550 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Lymphocyte subsets [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Posttransplant humoral alloreactivity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety and tolerability of CP-690,550 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: August 2007
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 select standard of care medications.
 Drug: CP-690-,550
CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12

  Eligibility

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

Inclusion Criteria:

  • Recipient of 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: NCT00556257

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: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00556257     History of Changes
Other Study ID Numbers: A3921037
Study First Received: November 8, 2007
Last Updated: May 27, 2008
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 June 17, 2013