Study Evaluating Rapamune in Patients After Kidney Transp... | NCT00240214

Studies
Study Evaluating Rapamune in Patients After Kidney Transplantation

NCT00240214

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Terminated

Last Update Posted

Mar 14, 2008Estimated

Enrollment

500Actual

Phase

Not provided

Conditions

Renal Transplantation

Interventions

sirolimus

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2001

Primary Completion Date

Feb 2008Actual

Completion Date

Feb 2008Actual

First Submitted Date

Oct 13, 2005

First Submission Date that Met QC Criteria

Oct 13, 2005

First Posted Date

Oct 17, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2008

Last Update Posted Date

Mar 14, 2008Estimated

Description Module

Brief Summary

The purpose of this study is to obtain data on the effectiveness and safety of Rapamune under everyday conditions

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		sirolimus	Drug: sirolimus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sirolimus	Drug	Tablet, dosage is determined by trough level	1

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director
Trial Manager	For Germany, medinfoDEU@wyeth.com	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Multiple Cities			Germany

Intervention Browse Module

MeSH Terms

ID	Term
D020123	Sirolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided