Pharmacokinetics and Pharmacodynamics of MPA in Stable Re... | NCT00780429

Studies
Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients

NCT00780429

Sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Status

Unknown status

Last Update Posted

Oct 27, 2008Estimated

Enrollment

54Actual

Phase

Not provided

Conditions

Kidney Transplantation

Interventions

Not provided

Countries

Italy

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

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 24, 2008

First Submission Date that Met QC Criteria

Oct 24, 2008

First Posted Date

Oct 27, 2008Estimated

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

Oct 24, 2008

Last Update Posted Date

Oct 27, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study of the pharmacokinetic and pharmacodynamic variability of mycophenolate mofetil in renal transplant patients already on long-term MMF treatment (at least 6 months post-transplant; at least 3 months in therapy).

Study hypothesis: to investigate whether long-term MMF therapy alters IMPDH biological activity and if there are any correlations with the risk of AR.

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		MMF+cyclosporine
2		MMF+tacrolimus
3		MMF+sirolimus

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Renal transplant recipients
Age range: 18-70
Patients taking MMF
Able to understand and sign an informed consent

Exclusion Criteria:

Active myelodepression
Systemic infections or other that may affect MMF absorption
Pregnancy/breastfeeding
(History of) cancer
Drug abuse, psychiatric conditions
Already enrolled in other clinical trials or participation ended less than one month earlier
Known sensitivity to polysorbate 80 or MMF

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Male and female renal transplant patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Fondazione Policlinico San Matteo		Pavia		27100	Italy