Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients
NCT00254709
Last updated date
ABOUT THIS STUDY
The purpose of this study is to test two different sirolimus-based immunosuppressive regimens
for elderly kidney transplant recipients.
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
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Failure, Graft Rejection, Aged
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
60 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- End stage renal disease
- Kidney transplantation
- Both donor and recipient older than 60 years
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Prior or concurrent transplant of any organ other than the kidney
- Current clinically significant infections
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Kidney Failure, Graft Rejection, AgedStudy Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients
NCT00254709
ALL GENDERS
60 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients | |||
| Official Title ICMJE | Open, Pilot, Comparative Study to Evaluate the Efficacy and Safety of Two Immunosuppressor Regimens, Anti Il-2, Sirolimus Mycophenolate, Mophetyl and Steroids Versus Sirolimus, Cyclosporine, and Withdrawal of Cyclosporine Since the Third Month and Steroids in Elderly Population | |||
| Brief Summary | The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients. | |||
| 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 | Drug: Sirolimus | |||
| 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 | |||
| Actual Enrollment ICMJE | 66 | |||
| Original Enrollment ICMJE | 80 | |||
| Actual Study Completion Date ICMJE | September 2005 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 60 Years and older (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 | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00254709 | |||
| Other Study ID Numbers ICMJE | 0468-100970 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| 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 | January 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||