A Study Of CP-690,550 In Stable Kidney Transplant Patients

Pfizer

Status and phase: Completed; Phase 1

Conditions: Kidney Transplant

Treatments: Drug: Placebo; Drug: CP-690,550 30 mg BID; Drug: CP-690,550 5 mg BID; Drug: CP-690,550 15 mg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01710033

A3921007

Details and patient eligibility

About

This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients. In Stage 1, ascending doses of CP-690,550 were to be administered sequentially to 3-4 cohorts of subjects. After Stage 1, one dose level was to be selected for dosing in an expanded cohort in Stage 2.

Enrollment: 28 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medically stable kidney transplant patients 6 or more months after transplantation.
• Subjects must be on mycophenolate mofetil 1-2 gm daily
• In Cohort 3 (and 4, if conducted) in Stage 1 and the expanded cohort in Stage 2, subjects must be on a calcineurin inhibitor-free regimen.

Exclusion criteria

• Any rejection episodes in the preceding 3 months.
• Treated with Thymoglobulin or OKT3 for acute rejection in the past 6 months.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

CP-690,550 5 mg BID

Experimental group

Treatment:

Drug: CP-690,550 5 mg BID

CP-690,550 15 mg BID

Experimental group

Treatment:

Drug: CP-690,550 15 mg BID

CP-690,550 30 mg BID

Experimental group

Treatment:

Drug: CP-690,550 30 mg BID