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

Completed · Phase 2

Conditions studied: Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT00263328

Run by

Pfizer

People needed

46

Starts

2005-12-01

Expected to finish

2014-06-01

Last updated by the study team

2015-07-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Multi Organ Transplant Center — Los Angeles, California, United States
• St. Vincent Medical Center — Los Angeles, California, United States
• Transplant Research Institute — Los Angeles, California, United States
• Stanford School of Medicine — Palo Alto, California, United States
• Balboa Institute of Transplantation — San Diego, California, United States
• California Institute of Renal Research — San Diego, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California, San Francisco, Kidney Transplant Unit — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado Health Sciences Center Renal Clinical Trials Office — Aurora, Colorado, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Northwestern University-Feinberg School of Medicine, Division of Organ Transplantation — Chicago, Illinois, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Jack J Dreyfus Clinic — New York, New York, United States
• Recanati/Miller Transplantation Institute — New York, New York, United States
• New York Presbyterian Hospital / Weill Cornell Medical Center — New York, New York, United States
• Legacy Good Samaritan Hospital — Portland, Oregon, United States
• Legacy Transplant Services — Portland, Oregon, United States
• Northwest Renal Clinic — Portland, Oregon, United States
• Dallas Transplant Institute — Dallas, Texas, United States
• Annette C & Harold C Simmons Transplant Institute — Dallas, Texas, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Baylor All Saints Medical Center — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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