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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00556257

Enrollment

Registered

2007-11-09

Start date

2007-08-31

Completion date

Unknown

Last updated

2008-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Immunosuppression, JAK3 inhibitor, kidney transplantation

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.

Interventions

DRUGCyclosporine

Standard of care

DRUGCP-690-,550

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Clinical biopsy proven acute rejection rate at 6 months	6 months

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026