NCT00676221

Brief Summary

Hypothesis: Presently, some patients' mycophenolate mofetil (MMF.,Cellcept) related gastrointestinal (GI) symptoms are not being spontaneously reported. It is postulated that a conversion to enteric-coated mycophenolate sodium (EC-MPS.,Myfortic) from MMF will reduce the objectively measured GI symptom burden and improve GI-related quality of life. Primary Objective: To determine the incidence of GI-related symptoms and the health related quality of life of renal transplant patients that are currently tolerating MMF. Assessed by GSRS and GIQLI. Secondary Objective: To determine the impact on GI symptoms and the health related quality of life of renal transplant patients converted from MMF to Myfortic. Assessed by GSRS and GIQLI.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

May 15, 2008

Status Verified

May 1, 2008

Enrollment Period

2.1 years

First QC Date

May 8, 2008

Last Update Submit

May 14, 2008

Conditions

Kidney Transplant

Keywords

Renal transplant recipientImmunosuppressionGastro-intestinal symptomsQuality of lifeCellceptMyforticKidney transplant patients.

Outcome Measures

Primary Outcomes (1)

  • To determine the incidence of GI related symptoms (GSRS) and the health related quality of life (GIQLI) of renal transplant recipients who are currently tolerating or willing to tolerate MMF.

    12 weeks

Secondary Outcomes (4)

  • To determine the impact on GI symptoms and the health related quality of life of renal transplant patients converted from MMF to EC-MPS.

    12 weeks

  • Adverse events.

    12 weeks

  • Renal function as determined by Cockroft-Gault equation.

    12 weeks

  • Routine hematological and biochemical bloodwork changes.

    12 weeks

Interventions

MyforticDRUG

Mycophenolate Mofetil (Cellcept) discontinued at Baseline visit. Mycophenolate Sodium(Myfortic)commenced the following day at equimolar doses orally BID. Cellcept 1000mg bid = Myfortic 720mg bid

Also known as: EC-MPS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable primary or secondary renal transplant recipients, males and females. 18-75 years of age.
  • Stable GFR (\>30ml/min) Cockroft-Gault equation at time of last clinic visit and at Screening/Baseline visit.
  • Immunosuppression drug regimen that includes MMF(Cellcept)for at least 4 weeks prior to study enrollment.
  • Renal transplant recipients who are tolerating or willing to tolerate GI symptoms related to MMF.
  • Patients willing and capable of given written informed consent for study participation.

You may not qualify if:

  • Non-stable renal transplant recipients ( infection, thrombocytopenia,neutropenia, anemia, fluctuating GFR, acute rejection \< 1 week prior to study enrollment etc.)
  • Malignancies other than treated basal cell and squamous cell carcinoma of the skin.
  • Other serious medical conditions ( uncontrolled diabetes, peptic ulcers, etc)
  • GI symptoms not related to MMF (ie infectious diarrhoea)
  • Women of childbearing potential who are unwilling to use effective means of contraception.
  • Presence of psychiatric illness that would interfere with study requ1rements.
  • Ongoing acute medical intervention or hospitalization.
  • Patients receiving any investigational drug or having received any investigational drug within 30 days prior to study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Serdar Yilmaz, MD., PhD

    Foothills Medical Centre, Div. of Transplant Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 12, 2008

Study Start

July 1, 2006

Primary Completion

August 1, 2008

Study Completion

September 1, 2008

Last Updated

May 15, 2008

Record last verified: 2008-05

Locations

CA(1)