A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients

Pfizer

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00106639

A3921009

Details and patient eligibility

About

This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.

Enrollment: 61 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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61 participants in 3 patient groups

CP-690,550 15 mg BID

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

CP-690,550 30 mg BID

Experimental group

Treatment:

Drug: CP-690,550

Drug: CP-690,550

tacrolimus

Active Comparator group

Treatment:

Drug: tacrolimus