Study Comparing Conversion to Sirolimus vs. Continued Use... | NCT00038948

NCT00038948

Protocol Section

Identification Module

Results Section

Participant Flow Module

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

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression	Drug: Sirolimus Drug: tacrolimus Drug: Cyclosporine A
B	Active Comparator	Continued calcineurin inhibitor therapy	Drug: Sirolimus Drug: tacrolimus Drug: Cyclosporine A

Name	Type	Description	Arm Group Labels	Other Names
Sirolimus	Drug	Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled	A B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nankivell Glomerular Filtration Rate (GFR)	Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.	52 weeks

Secondary Outcomes

Measure	Description	Time Frame
First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.	Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).	52 and 104 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Monitor, MD	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22143911	Derived	Reichen J, Stickel F, Bhattacharya I, Matschke K, Maller E, Korth-Bradley J. Repeat-dose sirolimus pharmacokinetics and pharmacodynamics in patients with hepatic allografts. Eur J Clin Pharmacol. 2012 May;68(5):589-97. doi: 10.1007/s00228-011-1172-7. Epub 2011 Dec 6.

Arm/Group Information

ID	Title	Description
FG000	SRL Conversion in Stable Renal Transplant Recipients	Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
FG001	CNI Continuation in Stable Renal Transplant Recipients	Continued calcineurin inhibitor immunosuppression therapy

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000555 subjects FG001275 subjects
COMPLETED		FG000386 subjects FG001198 subjects
NOT COMPLETED		FG000169 subjects FG00177 subjects

Type	Comment	Reasons
Adverse Event		FG000131 subjects FG00143 subjects
Lost to Follow-up		FG0004 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	SRL Conversion in Stable Renal Transplant Recipients	Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
BG001	CNI Continuation in Stable Renal Transplant Recipients

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Median

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Nankivell Glomerular Filtration Rate (GFR)

Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.

Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min.

Posted

May 2009

Mean

Standard Error

mL/min

52 weeks

ID	Title	Description
OG000	SRL Conversion Strata 20.0-40.0 mL/Min	Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in stable renal transplant recipients
OG001	CNI Continuation Strata 20.0-40.0 mL/Min

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SRL Conversion in Stable Renal Transplant Recipients	Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal pain	General disorders		Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Abdominal pain	General disorders		Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
U. S. Contact Center	Wyeth			clintrialresults@wyeth.com

Intervention Browse Module

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D003524	Cyclosporins