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

Last updated on May 10, 2018

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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Study Evaluating The Use Of Sirolimus In Recipients Of Kidney Allografts From Expanded Criteria Donors (ECD)
Surveillance Registry Of Sirolimus Use In Recipients Of Kidney Allograft From Expanded Criteria Donors (ECD)
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.
pilot study
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Kidney allograft recipients
Renal Transplantation
Drug: Sirolimus
Non interventional. Sirolimus administered by Principal Investigator per standard practice and labeling.
Other Name: Rapamune
A
Intervention: Drug: Sirolimus
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
December 2012
December 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
 
NCT00697112
0468H-102385
B1741025
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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