A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
NCT00195429
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
- End-stage renal disease, with patients scheduled to receive a kidney transplant.
- Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;
- Signed informed consent.
- Evidence of active systemic or localized major infection at the time of initial study
drug administration;
- Multiple organ transplants;
- Any pathology or medical condition that can interfere with this protocol study
proposal.
Other exclusion applies.
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
- Curitiba, PR
- Rio de Janeiro, RJ
- Rio de Janeiro, RJ
- Porto Alegre, RS
- Porto Alegre, RS
- Ribeirao Preto, RS
- Sao Jose do Rio Preto, SP
- Sao Paulo, SP
- Sao Paulo, SP
- Sao Paulo, SP
- Torreon, Coahuila
- Chihuahua,
- Mexico City DF,
- Sao Paulo,
- Bangalore, Karnataka
- Bangalore, Karnataka
- Saket, South Delhi
- Chennai, Tamil Nadu
- New Delhi,
- Roma, Lazio
- Roma, Lazio
- Palermo, Sicily
- Bari,
- Bologna,
- Cagliari,
- Firenze,
- L'Aquila,
- Milano,
- Pisa,
- Sassari,
- Siena,
- Udine,
- Varese,
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients | ||||||
Official Title ICMJE | A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients | ||||||
Brief Summary | This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE |
| ||||||
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 | 47 | ||||||
Original Enrollment ICMJE | 60 | ||||||
Actual Study Completion Date ICMJE | October 2007 | ||||||
Primary Completion Date | Not Provided | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other exclusion applies. | ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 13 Years and older (Child, 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 | Brazil | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00195429 | ||||||
Other Study ID Numbers ICMJE | 0468E-101535 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Not Provided | ||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||
Verification Date | April 2010 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |