NCT00943228

Brief Summary

The primary objective of this study is to determine whether 4 grams daily of mycophenolate mofetil (MMF) results in a greater proportion of individuals adequately exposed as measured by drug levels (area under the curve of \> 40 mg\*hr/L).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2010

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

First Submitted

Initial submission to the registry

July 6, 2009

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

August 9, 2012

Status Verified

August 1, 2012

Enrollment Period

2 years

First QC Date

July 6, 2009

Last Update Submit

August 8, 2012

Conditions

Acute Rejection of Renal Transplant

Keywords

Renal transplantationAdequate exposureAcute rejectionmycophenolate mofetilimmunosuppression

Outcome Measures

Primary Outcomes (1)

  • Adequate drug exposure. MPA AUC > 40 mg*hr/l

    First two weeks - 14 days

Secondary Outcomes (2)

  • Gastrointestinal symptoms (nausea, vomiting, abdominal pain, diarrhea).

    First two weeks - 14 days

  • Leukopenia, anemia, thrombocytopenia and infection.

    First two weeks - 14 days

Study Arms (1)

mycophenolate mofetil

EXPERIMENTAL

mycophenolate mofetil 2000mg BID (4g/day) for 14 days, followed by mycophenolate 1000mg BID (2g/day) thereafter

Drug: mycophenolate mofetil

Interventions

mycophenolate mofetilDRUG

High dose 4gms daily

Also known as: MMF, Cellcept
mycophenolate mofetil

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing single organ kidney transplantation.
  • Age \> 18 years old.
  • Patients who would normally receive our standard therapy of basiliximab, tacrolimus, MMF and steroids.
  • All patients will be required to sign informed consent.

You may not qualify if:

  • Patients will be excluded if they require anti-thymocyte induction therapy, have documented gastroparesis, have known intolerance to MMF, or are prescribed cyclosporine.
  • As a standard policy all women of childbearing age will be informed about the risks of all immunosuppressive drugs on fetal outcomes and will be required to use 2 forms of birth control.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Related Publications (1)

  • Kiberd BA, Lawen J, Daley C. Limits to intensified mycophenolate mofetil dosing in kidney transplantation. Ther Drug Monit. 2012 Dec;34(6):736-8. doi: 10.1097/FTD.0b013e31826d7bfa.

    PMID: 23007746DERIVED

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Bryce A Kiberd, MD

    Dalhousie University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2009

First Posted

July 22, 2009

Study Start

February 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

August 9, 2012

Record last verified: 2012-08

Locations

CA(1)