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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Foothills Medical Centre.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Novartis
Information provided by:
Foothills Medical Centre
ClinicalTrials.gov Identifier:
NCT00676221
First received: May 8, 2008
Last updated: May 14, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Kidney Transplant
Drug: Myfortic
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient Reported Outcomes in Renal Transplant Patients Tolerating GI Symptoms Converted to Myfortic (EC-MPS).

Resource links provided by NLM:


Further study details as provided by Foothills Medical Centre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the impact on GI symptoms and the health related quality of life of renal transplant patients converted from MMF to EC-MPS. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Adverse events. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Renal function as determined by Cockroft-Gault equation. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Routine hematological and biochemical bloodwork changes. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: July 2006
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Myfortic

    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

    Other Names:
    • Myfortic
    • EC-MPS
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676221

Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N2T9
Sponsors and Collaborators
Foothills Medical Centre
Novartis
Investigators
Principal Investigator: Serdar Yilmaz, MD., PhD Foothills Medical Centre, Div. of Transplant Surgery
  More Information

No publications provided

Responsible Party: Serdar Yilmaz MD., PhD., FACS. Regional Chief, Div. of Transplant Surgery, Foothills Medical Centre, Div. of Transplant Surgery
ClinicalTrials.gov Identifier: NCT00676221     History of Changes
Other Study ID Numbers: E-20097
Study First Received: May 8, 2008
Last Updated: May 14, 2008
Health Authority: Canada: Health Canada

Keywords provided by Foothills Medical Centre:
Renal transplant recipient
Immunosuppression
Gastro-intestinal symptoms
Quality of life
Cellcept
Myfortic
Kidney transplant patients.

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014