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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00263328
First received: December 6, 2005
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: Tacrolimus
Drug: CP-690,550
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Multicenter, Phase 2, Open-Label, Controlled, Extension Study For Stage 1 Subjects Of Study A3921009 To Evaluate The Long-Term Safety And Efficacy Of CP-690,550 Versus Tacrolimus, When Co-Administered With Mycophenolate Mofetil In Renal Allograft Recipients

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To evaluate the long-term safety of CP-690,550. [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the long-term efficacy of CP-690,550. [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: December 2005
Estimated Study Completion Date: June 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment group 1
Standard of care
Drug: Tacrolimus
Standard of care
Experimental: Treatment group 2
Treatment group 2 also receives mycophenolate mofetil
Drug: CP-690,550
CP-690,550 5 mg BID
Experimental: Treatment group 3
Treatment group 3 does not receive mycophenolate mofetil
Drug: CP-690,550
CP-690,550 10 mg BID

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263328

Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90057
Pfizer Investigational Site
Palo Alto, California, United States, 94304
Pfizer Investigational Site
San Diego, California, United States, 92123
Pfizer Investigational Site
San Francisco, California, United States, 94143-0780
Pfizer Investigational Site
San Francisco, California, United States, 94115
Pfizer Investigational Site
Stanford, California, United States, 94305
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110-1092
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
New York, New York, United States, 10065
Pfizer Investigational Site
New York, New York, United States, 10029
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97210
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Dallas, Texas, United States, 75204
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00263328     History of Changes
Other Study ID Numbers: A3921021
Study First Received: December 6, 2005
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
immunosuppression
JAK3 inhibitor
kidney transplant
tofacitinib
Xeljanz
CP-690
550
tacromilus
mycophenolate mofetil

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014