Study Comparing Standard Dose and Reduced Dose Tacrolimus... | NCT00518271

Studies
Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients

NCT00518271

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Aug 20, 2007Estimated

Enrollment

120Actual

Phase

Phase 2

Conditions

Kidney Transplantation

Interventions

Rapamune® (Sirolimus)
Tacrolimus
Corticosteroids

Countries

Not provided

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

Aug 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2000

Primary Completion Date

Not provided

Completion Date

Jun 2002Actual

First Submitted Date

Jul 26, 2007

First Submission Date that Met QC Criteria

Aug 16, 2007

First Posted Date

Aug 20, 2007Estimated

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

Aug 16, 2007

Last Update Posted Date

Aug 20, 2007Estimated

Description Module

Brief Summary

Detailed Description

This study evaluated renal graft function based on calculated creatinine clearance at 6 months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated at 6 months post transplantation.

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
Rapamune® (Sirolimus)	Drug
Tacrolimus	Drug
Corticosteroids	Drug	Perioperative

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Graft function as measured by calculated creatinine clearance at month 6 post-transplantation.

Secondary Outcomes

Measure	Description	Time Frame
Blood serum creatinine, incidence of biopsy-confirmed acute graft rejection, and patient and graft survival at 6 months; presumptive acute rejection; incidence of infection; histologically-confirmed lymphoproliferative disease or malignancy.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

At least 18 years of age
End-stage renal disease in patients receiving a primary or secondary renal allograft from a cadaveric donor
Patients with secondary kidney transplant must have maintained their primary graft for at least 6 months

Exclusion criteria

Planned antibody induction
Multiple organ transplants
Patients at high risk of acute rejection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020123	Sirolimus
D016559	Tacrolimus
D000305	Adrenal Cortex Hormones

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D006728	Hormones
D006730

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