Study Evaluating Sirolimus in Kidney Transplant Recipients in India
NCT00195481
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
- Patients in End Stage Renal Disease who are above 13 years of age and weigh more than 40 kilograms.
- Patients scheduled to receive a kidney from a cadaveric donor, from a living unrelated donor or from a living related donor.
- Evidence of major infections at the time of sirolimus administration
- Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the
study and during the treatment phase.
- Females who are pregnant, breast feeding or in reproductive age group and not using a
medically acceptable form of contraception
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 | Study Evaluating Sirolimus in Kidney Transplant Recipients in India | |||
Official Title ICMJE | A Post Marketing Surveillance Looking at Safety of Rapamune (Sirolimus) in Indian Population Undergoing de Novo Renal Transplantation. | |||
Brief Summary | To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: Rapamune | |||
Study Arms ICMJE | Not Provided | |||
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 | |||
Enrollment ICMJE | 100 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2005 | |||
Actual Primary Completion Date | December 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
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 | India | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00195481 | |||
Other Study ID Numbers ICMJE | 0468H-101543 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
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 | December 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |