Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
NCT00263328
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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.
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
- 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,
- 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
- 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,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient | |||
Official Title ICMJE | 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 | |||
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 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. | |||
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 * | Busque S, Leventhal J, Brennan DC, Steinberg S, Klintmalm G, Shah T, Mulgaonkar S, Bromberg JS, Vincenti F, Hariharan S, Slakey D, Peddi VR, Fisher RA, Lawendy N, Wang C, Chan G. Calcineurin-inhibitor-free immunosuppression based on the JAK inhibitor CP-690,550: a pilot study in de novo kidney allograft recipients. Am J Transplant. 2009 Aug;9(8):1936-45. doi: 10.1111/j.1600-6143.2009.02720.x. | |||
* 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 | 46 | |||
Original Enrollment ICMJE | 54 | |||
Actual Study Completion Date ICMJE | June 2014 | |||
Actual Primary Completion Date | January 2014 (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 | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00263328 | |||
Other Study ID Numbers ICMJE | A3921021 | |||
Has Data Monitoring Committee | No | |||
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 | June 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |