NCT00556257

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
Last Updated

May 30, 2008

Status Verified

May 1, 2008

First QC Date

November 8, 2007

Last Update Submit

May 27, 2008

Conditions

Kidney Transplantation

Keywords

Immunosuppression, JAK3 inhibitor, kidney transplantation

Outcome Measures

Primary Outcomes (1)

  • Clinical biopsy proven acute rejection rate at 6 months

    6 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

Treatment Arm 1

ACTIVE COMPARATOR

Treatment Arm 1 will also receive standard of care medications.

Drug: Cyclosporine

Treatment Arm 2

EXPERIMENTAL

Treatment Arm 2 will also receive select standard of care medications.

Drug: CP-690-,550

Interventions

CyclosporineDRUG

Standard of care

Treatment Arm 1
CP-690-,550DRUG

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

Treatment Arm 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recipient of first time kidney transplant
  • Between the ages of 18 and 70 years, inclusive

You may not qualify if:

  • Recipient of any non-kidney transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 8, 2007

First Posted

November 9, 2007

Study Start

August 1, 2007

Last Updated

May 30, 2008

Record last verified: 2008-05