The Effect of Sirolimus on the Pharmacokinetics of Tacrol... | NCT00166829

Studies
The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus

NCT00166829

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Mar 8, 2007Estimated

Enrollment

Phase

Phase 4

Conditions

Kidney Transplantation

Interventions

sirolimus, tacrolimus, mycophenolate mofetil

Countries

Taiwan

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 2003

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 14, 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 7, 2007

Last Update Posted Date

Mar 8, 2007Estimated

Description Module

Brief Summary

The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.

Detailed Description

The controlled clinical trial held in NTUH in 2001 revealed that the bioavailability of tacrolimus when combined with sirolimus is lower than that reported in the literature where tacrolimus was not combined with sirolimus. To determine if the difference was due to the drug interaction between sirolimus and tacrolimus, a controlled clinical trial was proposed.

The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.

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

Name	Type	Description	Arm Group Labels	Other Names
sirolimus, tacrolimus, mycophenolate mofetil	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients

Secondary Outcomes

Measure	Description	Time Frame
Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

De novo kidney transplant patients
Aged 13 - 65 years
Having aminotransferase concentrations within 2 times the upper limit of normal

Exclusion Criteria:

Pregnancy
Tuberculosis
Hepatitis B or C carrier status
Human immunodeficiency virus-positive status
Retransplantation or multi-organ transplantation
History of rheumatoid arthritis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meng-Kun Tsai, MD, PhD	Contact	886-2-23123456	5622	mark9@ha.mc.ntu.edu.tw
Fe-Lin L Wu, PhD	Contact	886-2-23123456	8389	flwu@ha.mc.ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Po-Huang Lee, MD, PhD	National Taiwan University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19670189	Derived	Tsai MK, Wu FL, Lai IR, Lee CY, Hu RH, Lee PH. Decreased acute rejection and improved renal allograft survival using sirolimus and low-dose calcineurin inhibitors without induction therapy. Int J Artif Organs. 2009 Jun;32(6):371-80. doi: 10.1177/039139880903200608.

ID	Term
D020123	Sirolimus
D016559	Tacrolimus
D009173	Mycophenolic Acid

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D002208	Caproates
D000144