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Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients

NCT00483756 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2013-03-14

Study results available
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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. 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.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Cyclosporine

Standard of care

DRUG

CP-690,550

CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12

DRUG

CP-690,550

CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-02-28
Completion
2010-04-30

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00483756 on ClinicalTrials.gov