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Study Evaluating Rapamune in Patients After Kidney Transplantation

Last updated on November 16, 2019

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Study Location
Multiple Cities, , Germany
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
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients having received a renal allograft from a cadaveric or living donor with low
or moderate risk of developing acute rejection episodes.

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

- Contraindications according to Summary of the Product Characteristics (SmPC).

NCT00240214
Pfizer
Terminated
Study Evaluating Rapamune in Patients After Kidney Transplantation

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Descriptive Information
Brief TitleStudy Evaluating Rapamune in Patients After Kidney Transplantation
Official TitleAn Open Label Post Marketing Surveillance Assessment to Evaluate the Effectiveness and Safety of Rapamune in Patients After Kidney Transplantation Receiving a Rapamune Containing Regime
Brief SummaryThe purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationprimary care clinic
ConditionRenal Transplantation
InterventionDrug: sirolimus
Tablet, dosage is determined by trough level
Study Groups/Cohorts1
sirolimus
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 StatusTerminated
Actual Enrollment
 (submitted: October 13, 2005)
500
Original EnrollmentSame as current
Actual Study Completion DateFebruary 2008
Actual Primary Completion DateFebruary 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients having received a renal allograft from a cadaveric or living donor with low or moderate risk of developing acute rejection episodes.

Exclusion Criteria:

  • Contraindications according to Summary of the Product Characteristics (SmPC).
Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesGermany
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00240214
Other Study ID Numbers0468E-100875
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Germany, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMarch 2008

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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