AzTrials
AzTrials

Kidney TransplantPhase 4NCT00676221

Patient Reported Outcomes in Renal Transplant Patients Tolerating Gastrointestinal (GI) Symptoms Converted to Myfortic (EC-MPS)

A Phase 4 study testing Myfortic in people with Kidney Transplant, run by Foothills Medical Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Kidney Transplant
What is being tested?
Myfortic
Type of treatment
Pill or oral medicine
How many people
110 participants
Where
1 siteCanada
Study dates
Jul 2006to Sep 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Foothills Medical Centre

    Calgary, Alberta, T2N2T9

Other trials in Canada

About this study

Official title: Patient Reported Outcomes in Renal Transplant Patients Tolerating GI Symptoms Converted to Myfortic (EC-MPS).

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.

Read the detailed description

Investigator originated proposal. Single centre-Foothills Medical Centre, Southern Alberta Transplant Program.

Study design: Three month, longitudinal, open-label, single arm study. Number of study visits: 3 (Baseline, 4-6 weeks, 12 weeks)

Planned sample size :Approx. 110 subjects. Study population will be primary or secondary renal transplant recipients who are stable and are on maintenance immunosuppressive medication which includes MMF.

Gastrointestinal rating scale (GSRS) and Gastrointestinal Quality of Life Index (GIQLI)will be the evaluation tool for GI symptoms, completed by study subject via a "touch screen" pc. at baseline, 4-6 week and final 12 week visit.

Study subjects will discontinue MMF following the evening dose on the day of Baseline visit and commence EC-MPS at equimolar doses of subject's current MMF dose.

At Final study visit (Week 12) study subject will be given the option of continuing on EC-MPS or resuming MMF.

Endpoints:

Primary: Incidence of patients tolerating MMF related GI symptoms.

Secondary:

  1. Patient reported symptoms and quality of life after conversion from MMF to EC-MPS.
  2. Adverse events.
  3. Renal function as determined by Cockroft-Gault equation
  4. Routine hematological and chemistry bloodwork.

Statistical consideration: Descriptive, pair T-Test analysis.

Being tested
Myfortic
Keywords
Renal transplant recipient, Immunosuppression, Gastro-intestinal symptoms, Quality of life, Cellcept, Myfortic, Kidney transplant patients.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MyforticDrug

    Also called EC-MPS

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (4)

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

    Measured: 12 weeks

  2. Adverse events.

    Measured: 12 weeks

  3. Renal function as determined by Cockroft-Gault equation.

    Measured: 12 weeks

  4. Routine hematological and biochemical bloodwork changes.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2008 (estimated)
  2. Study startJul 2006
  3. Primary completionAug 2008 (estimated)
  4. Study completionSep 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00676221
Sponsor's protocol ID
E-20097
Status last verified
May 2008
First submitted
8 May 2008
Last updated
15 May 2008
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Myfortic in people with Kidney Transplant, run by Foothills Medical Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00676221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in