Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
NCT00483756
Last updated date
ABOUT THIS STUDY
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 this
research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant
patients for 12 months. Patients will be assigned to one of three treatment groups after
receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing
regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be
a standard-of-care control arm. Patients will continue to take the assigned study medication
for 12 months as well as other standard transplant medications such as prednisone.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Kidney Transplantation
Sex
Females and Males
Age
18-70 years
Inclusion Criteria
Show details
- Recipient of a first-time kidney transplant
- Between the ages of 18 and 70 years, inclusive
Exclusion Criteria
Show details
- Recipient of any non-kidney transplant
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Kidney TransplantationStudy Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients
NCT00519116
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Kidney TransplantationCollection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients
NCT01375127
- Los Angeles, California
- Los Angeles, California
- Palo Alto, California
- San Francisco, California
- San Francisco, California
- Stanford, California
- Aurora, Colorado
- Tampa, Florida
- Chicago, Illinois
- Chicago, Illinois
- Boston, Massachusetts
- Springfiled, Massachusetts
- Ann Arbor, Michigan
- Detroit, Michigan
- St. Louis, Missouri
- Livingston, New Jersey
- New York, New York
- Valhalla, New York
- Chapel Hill, North Carolina
- Dallas, Texas
- Dallas, Texas
- Fort Worth, Texas
- Richmond, Virginia
- Camperdown, New South Wales
- Westmead, New South Wales
- Adelaide, South Australia
- Clayton, Victoria
- Parkville, Victoria
- Anderlecht,
- Porto Alegre, RS
- Sao Paulo, SP
- Edmonton, Alberta
- Praha 4 - Krc,
- Nantes Cedex 1,
- Paris Cedex 15,
- Toulouse Cedex 9,
- Berlin,
- Hamburg,
- Roma,
- Rotterdam,
- Oslo,
- L'Hospitalet de Llobregat, Barcelona
- Barcelona,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Kidney TransplantationA 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients
NCT00106639
- Los Angeles, California
- Los Angeles, California
- Palo Alto, California
- San Diego, California
- San Francisco, California
- San Francisco, California
- Stanford, California
- Denver, Colorado
- Chicago, Illinois
- New Orleans, Louisiana
- St. Louis, Missouri
- St. Louis, Missouri
- Livingston, New Jersey
- New York, New York
- New York, New York
- Portland, Oregon
- Dallas, Texas
- Dallas, Texas
- Richmond, Virginia
- Milwaukee, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Kidney TransplantationStudy of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients
NCT00483756
- Little Rock, Arkansas
- Los Angeles, California
- Los Angeles, California
- Palo Alto, California
- San Diego, California
- San Francisco, California
- San Francisco, California
- Stanford, California
- Aurora, Colorado
- New Haven, Connecticut
- New Haven, Connecticut
- Gainesville, Florida
- Gainsville, Florida
- Tampa, Florida
- Chicago, Illinois
- Chicago, Illinois
- Baltimore, Maryland
- Boston, Massachusetts
- Springfield, Massachusetts
- Springfield, Massachusetts
- Ann Arbor, Michigan
- Detroit, Michigan
- Rochester, Minnesota
- St. Louis, Missouri
- Livingston, New Jersey
- New York, New York
- Valhalla, New York
- Chapel Hill, North Carolina
- Chapel Hill, North Carolina
- Chapel Hill, North Carolina
- Chapel Hill, North Carolina
- Portland, Oregon
- Philadelphia, Pennsylvania
- Charleston, South Carolina
- Dallas, Texas
- Dallas, Texas
- Fort Worth, Texas
- Camperdown, New South Wales
- Westmead, New South Wales
- Adelaide, South Australia
- Woodville, South Australia
- Clayton, Victoria
- Parkville, Victoria
- Anderlecht,
- Leuven,
- Porto Alegre, RS
- Sao Paulo, SP
- Sao Paulo, SP
- Edmonton, Alberta
- Praha 4,
- Nantes,
- Paris Cedex 15,
- Toulouse Cedex 9,
- Vandoeuvre Les Nancy,
- Berlin,
- Hamburg,
- Bologna,
- Roma,
- Seoul,
- Seoul,
- Seoul,
- Rotterdam,
- Oslo,
- Warszawa,
- Wroclaw,
- Coimbra,
- Lisboa,
- Hospitalet de Llobregat, Barcelona
- Barcelona,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study of a JAK3 Inhibitor for the Prevention of Acute Rejection in Kidney Transplant Patients | |||
Official Title ICMJE | A Phase 2 Randomized, Multicenter, Active Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Co-administration of CP-690,550 and Mycophenolate Mofetil / Mycophenolate Sodium in De Novo Renal Allograft Recipients | |||
Brief Summary | 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 this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
Condition ICMJE | Kidney Transplantation | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 338 | |||
Original Enrollment ICMJE | 300 | |||
Actual Study Completion Date ICMJE | April 2010 | |||
Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Italy, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Spain, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00483756 | |||
Other Study ID Numbers ICMJE | A3921030 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |