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Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)

Last updated on December 10, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Caba, Buenos Aires, 1425 Argentina
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients aged 18 years or older.

- Patients who received a renal transplant (primary, secondary, tertiary, etc.) without
pancreas, from Expanded Criteria Donors (ECD), 3 months prior and no later than 1 year
at the time of study enrollment.

- Patients who provided informed consent.

- Patients without sirolimus as base therapy.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients who are unwilling or unable to provide informed consent or who lack a legal
guardian or designee able to provide consent on their behalf.

- Patients who are unable to complete the study.

- Patients who are participating in another clinical trial during the last 6 months.

- Pregnant or lactating patients.

NCT00697112
Pfizer
Completed
Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)

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Descriptive Information
Brief Title Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)
Official Title Surveillance Registry Of Sirolimus Use In Recipients Of Kidney Allograft From Expanded Criteria Donors (ECD)
Brief Summary The purpose of this observational study is to examine the clinical outcomes of the use of sirolimus as base therapy in kidney allograft recipients from Expanded Criteria Donors (ECD) under conditions of routine clinical practice. The primary objective is to identify the current criteria/reasons to use sirolimus as base therapy in this selected population and define and understand the emerging patterns of immunosuppressive treatment with sirolimus.
Detailed Description pilot study
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Kidney allograft recipients
Condition Renal Transplantation
Intervention Drug: Sirolimus
Non interventional. Sirolimus administered by Principal Investigator per standard practice and labeling.
Other Name: Rapamune
Study Groups/Cohorts A
Intervention: Drug: Sirolimus
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 Completed
Actual Enrollment
 (submitted: December 3, 2013)
53
Original Estimated Enrollment
 (submitted: June 12, 2008)
100
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients aged 18 years or older.
  • Patients who received a renal transplant (primary, secondary, tertiary, etc.) without pancreas, from Expanded Criteria Donors (ECD), 3 months prior and no later than 1 year at the time of study enrollment.
  • Patients who provided informed consent.
  • Patients without sirolimus as base therapy.

Exclusion Criteria:

  • Patients who are unwilling or unable to provide informed consent or who lack a legal guardian or designee able to provide consent on their behalf.
  • Patients who are unable to complete the study.
  • Patients who are participating in another clinical trial during the last 6 months.
  • Pregnant or lactating patients.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina
Removed Location Countries  
 
Administrative Information
NCT Number NCT00697112
Other Study ID Numbers 0468H-102385
B1741025
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2013

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

BY EMAIL

Contact

[email protected]

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