Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient

Pfizer

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00263328

A3921021

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 study A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months posttransplant. Patients who completed study A3921009 were offered the opportunity to participate in study A3921021 which will extend the evaluation of safety and efficacy of CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be discontinued.

Enrollment: 46 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrollment in Stage 1 of Study A3921009 and have completed 6-months of treatment with trial medications (CP-690,550 or tacrolimus)
• Recipient of a first-time kidney transplant

Exclusion criteria

• Subject with any untreated condition that may affect drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy).
• Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 3 patient groups

Treatment group 1

Active Comparator group

Description:

Standard of care

Treatment:

Drug: Tacrolimus

Treatment group 2

Experimental group

Description:

Treatment group 2 also receives mycophenolate mofetil

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Treatment group 3

Experimental group

Description:

Treatment group 3 does not receive mycophenolate mofetil

Treatment:

Drug: CP-690,550

Drug: CP-690,550