NCT00187941

Brief Summary

Individuals absorb Cellcept (MMF/Mycophenolate Mofetil) at different rates and it is difficult to determine an individuals level of Mycophenolate Mofetil (MMF, trade name Cellcept)from a single measurement. We will enroll 20 subjects. Plasma samples to be collected pre-MMF dose (trough level) and at 30 and 120 min after the morning dose of MMF.This will be done weekly for the first month and then monthly for the next 6 mths. We hope to use a calculation of the subjects total MMF level during the first month to set a trough target level to use during the next 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

1.3 years

First QC Date

September 13, 2005

Last Update Submit

June 19, 2012

Conditions

Transplantation, RenalImmunosuppression

Keywords

transplantrenalCellcepttherapeutic drug levelMMFMPAimmunosuppression

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients whose measured AUC falls within or outside the therapeutic MPA target range (30-60 mg/L/h) at any given follow up interval, as average over the whole time period.

    7 months

  • Proportion of patients achieving one or more therapeutic level AUC.

    7 months

Secondary Outcomes (5)

  • Incidence of acute rejection of transplanted kidney

    7 months

  • Incidence of potentially MPA related toxicities

    7 months

  • Number of dose changes needed to achieve MPA AUC target within the first month post-transplant

    1 months

  • Number of dose changes needed to achieve the individualized MPA trough target levels following the first month.

    6 months

  • To obtain 20 to 25 intraindividual correlation estimates (of one type or another) within each patient: trough vs. AUC.

    7 months

Study Arms (1)

CellCept

OTHER

CellCept + Prograf or Neoral + Steroids

Drug: Mycophenolate Mofetil

Interventions

Mycophenolate MofetilDRUG

Targeted MPA exposure to 30-60 mg/L/h during the first month post-transplant.

Also known as: CellCept, MMF, RO 70-0003
CellCept

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female, age 18-80
  • On Cellcept (MMF) and Prograf (tacrolimus) based immunosuppression
  • Recipient of cadaveric or living donated kidney transplants

You may not qualify if:

  • Documented non-compliance prior transplant
  • Serum albumin \<2.5 mg/dl
  • Primary non-function
  • Not on Prograf
  • Pregnant females
  • Active serious digestive system disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • Guerra G, Srinivas TR, Schold JD, Eagan AE, Nawrocki, Shaw L, Kaplan B, Womer K, Meier-Kriesche HU. Prospective Blinded Pharmacokinetic Trial to Establish an Individualized MPA Trough Regimen. American Transplant Congress, San Francisco, California

    BACKGROUND

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Herwig-Ulf Meier-Kriesche, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

August 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations

US(1)