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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

Treatments: Drug: Cyclosporine; Drug: CP-690,550

Study type: Interventional

Funder types: Industry

Identifiers

NCT00483756

A3921030

Details and patient eligibility

About

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.

Enrollment: 338 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Recipient of any non-kidney transplant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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338 participants in 3 patient groups

1

Active Comparator group

Description:

Treatment Arm 1 will also receive standard of care medications

Treatment:

Drug: Cyclosporine

2

Experimental group

Description:

Treatment Arm 2 will also receive standard of care medications

Treatment:

Drug: CP-690,550

Drug: CP-690,550

3

Experimental group

Description:

Treatment Arm 3 will also receive standard of care medications

Treatment:

Drug: CP-690,550

Drug: CP-690,550