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

Phase 2

Withdrawn

• Conditions: Kidney Transplantation
• Interventions: Drug: Cyclosporine; Drug: CP-690-,550

• Registration Number: NCT00556257
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-11-08
• Study First Submitted QC: 2007-11-08
• Study First Posted: 2007-11-09
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-27
• Last Update Posted: 2008-05-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm 1	Cyclosporine	Treatment Arm 1 will also receive standard of care medications.
Treatment Arm 2	CP-690-,550	Treatment Arm 2 will also receive select standard of care medications.

Primary Outcome Measures

Name	Time	Method
Clinical biopsy proven acute rejection rate at 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of CP-690,550	12 months
Lymphocyte subsets	12 months
Posttransplant humoral alloreactivity	12 months
Safety and tolerability of CP-690,550	12 months