Study Comparing Standard Dose and Reduced Dose Tacrolimus... | NCT00519116

Studies
Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients

NCT00519116

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Dec 11, 2023Actual

Enrollment

150

Phase

Phase 4

Conditions

Kidney Transplantation

Interventions

Rapamune® (Sirolimus)
Tacrolimus
Perioperative 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

Dec 2023

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

Oct 2000

Primary Completion Date

Not provided

Completion Date

Aug 2001

First Submitted Date

Jul 27, 2007

First Submission Date that Met QC Criteria

Aug 20, 2007

First Posted Date

Aug 21, 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

Dec 7, 2023

Last Update Posted Date

Dec 11, 2023Actual

Description Module

Brief Summary

Detailed Description

The study evaluated renal graft function (based on the calculated creatinine clearance) 6 months after kidney transplantation in patients receiving either a regimen of 'reduced-dose' tacrolimus + sirolimus + corticosteroids or a regimen of 'standard-dose' tacrolimus + sirolimus + corticosteroids. The two treatment groups were also compared with respect to the incidence of acute graft rejection at 6 months and patient and graft survival at 6 months after 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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
Rapamune® (Sirolimus)	Drug
Tacrolimus	Drug
Perioperative Corticosteroids	Drug	The corticosteroids use was left up to the investigators decision.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Calculated creatinine clearance at month 6 post transplantation		6 months

Secondary Outcomes

Measure	Description	Time Frame
Patient and graft survival at 6 months post transplantation; the safety of sirolimus + corticosteroids given concomitantly with reduced or standard dose tacrolimus		6 months

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, living-unrelated, or living-related mismatched donor
Patients with a secondary transplant must have maintained a primary graft for at least 6 months

Exclusion criteria:

Planned antibody induction
Multiple organ transplants
History of malignancy within five years of enrollment

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	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

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

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