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

• Sponsor: Pfizer (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT00556257
• Collaborator: (none)
• Enrollment: 0
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: Cyclosporine; Drug: CP-690-,550	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Clinical biopsy proven acute rejection rate at 6 months [6 months]

Secondary Outcome Measures

1. Pharmacokinetics of CP-690,550 [12 months]

2. Lymphocyte subsets [12 months]

3. Posttransplant humoral alloreactivity [12 months]

4. Safety and tolerability of CP-690,550 [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00556257
• Other Study ID Numbers: A3921037
• First Posted: Nov 9, 2007
• Last Update Posted: May 30, 2008
• Last Verified: May 1, 2008

• Keywords provided by , ,: Immunosuppression, JAK3 inhibitor, kidney transplantation
• Additional relevant MeSH terms: Cyclosporine; Cyclosporins

Study Results

No Results Posted as of May 30, 2008