Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients

Pfizer

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00658359

A3921050

2008-002345-23 (EudraCT Number)

Details and patient eligibility

About

This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.

Enrollment: 178 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who successfully completed Study A3921030

Exclusion criteria

• 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)

---

178 participants in 3 patient groups

Treatment Arm 1

Active Comparator group

Description:

Treatment Arm 1 will also receive standard of care medications

Treatment:

Drug: Cyclosporine

Treatment Arm 2

Experimental group

Description:

Treatment Arm 2 will also receive standard of care medications

Treatment:

Drug: CP-690,550

Drug: CP-690,550

Treatment Arm 3

Experimental group

Description:

Treatment Arm 3 will also receive standard of care medications

Treatment:

Drug: CP-690,550

Drug: CP-690,550