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

Pfizer

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Kidney Transplantation

Interventions

CyclosporineDRUG

Standard of care

CP-690-,550DRUG

CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical biopsy proven acute rejection rate at 6 months

Time frame: 6 months

Secondary Outcomes

Pharmacokinetics of CP-690,550

Time frame: 12 months

Lymphocyte subsets

Time frame: 12 months

Posttransplant humoral alloreactivity

Time frame: 12 months

Safety and tolerability of CP-690,550

Time frame: 12 months

Data from ClinicalTrials.gov

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