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Renal TransplantationPhase 4NCT00658333

A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms

A Phase 4 study testing Enteric-coated Mycophenolate Acid (EC-MPA) and Mycophenolate Mofetil (MMF) in people with Renal Transplantation, run by Novartis Pharmaceuticals at 37 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Renal Transplantation
What is being tested?
Enteric-coated Mycophenolate Acid (EC-MPA) and Mycophenolate Mofetil (MMF)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
37 sitesUnited States
Study dates
Mar 2008to Mar 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recipients of first or second cadaveric, living unrelated or living related kidney transplant.
  • Patients on a reduced daily dose (500mg to 1500mg) of MMF with existing but tolerable and controlled gastrointestinal symptoms.
  • Recipients who are at least 4 weeks post renal transplantation with stable renal function.

Who cannot join

  • Multi organ transplant or previous transplant with organ other than kidney
  • History of GI disorder prior to transplant
  • Evidence of GI disorder induced by infection, underlying medical condition, or con med other than MMF
  • Modification of GI med or MMF dose within one week
  • Evidence of graft rejection, treatment of acute rejection, unstable renal function within 1 week of (baseline) visit
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

United States37 sites

  • Novartis

    Aurora, Colorado, 80010

  • Novartis

    Baltimore, Maryland, 21201

  • Novartis

    Boston, Massachusetts, 02114

  • Novartis

    Boston, Massachusetts, 02215

  • Novartis

    Burlington, Vermont, 05401

  • Novartis

    Charlotte, North Carolina, 28207

  • Novartis

    Charlottesville, Virginia, 22908

  • Novartis

    Cleveland, Ohio, 44106

  • Novartis

    Dallas, Texas, 75230

  • Novarits

    Detroit, Michigan, 48236

  • Novartis

    Durham, North Carolina, 27710

  • Novarits

    Fargo, North Dakota, 58123

  • Novartis

    Greenville, North Carolina, 27834

  • Novartis

    Houston, Texas, 77054

  • Novartis

    Los Angeles, California, 90033

  • Novartis

    Los Angeles, California, 90057

  • Novartis

    Los Angeles, California, 90095

  • Novartis

    Murray, Utah, 84107

  • Novartis

    Nashville, Tennessee, 37232

  • Novartis

    New Orleans, Louisiana, 70121

  • Novartis

    New York, New York, 10029

  • Novartis

    New York, New York, 10032

  • Novartis

    New York, New York, 10065

  • Novartis

    Orange, California, 92868

  • Novartis

    Orlando, Florida, 32804

  • Novartis

    Philadelphia, Pennsylvania, 19140

  • Novartis

    Phoenix, Arizona, 85012

  • Novartis

    Portland, Maine, 04102

  • Novartis

    Portland, Oregon, 97210

  • Novartis

    Portland, Oregon, 97239

  • Novartis

    Providence, Rhode Island, 02903

  • Novartis

    San Diego, California, 92123

  • Novartis

    San Francisco, California, 94143

  • Novartis

    Springfield, Massachusetts, 01107

  • Novartis

    Temple, Texas, 76508

  • Novartis

    Washington D.C., District of Columbia, 20007

  • Novartis

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double Blind, Double Dummy Controlled Study to Assess the Tolerability of an Increased Dose of Enteric Coated MPA After Conversion From MMF in Renal Transplant Recipients Who Required MMF Dose Reductions Due to Gastrointestinal Symptoms

To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms

Being tested
Enteric-coated Mycophenolate Acid (EC-MPA), Mycophenolate Mofetil (MMF), Placebo MMF, Placebo EC-MPA
Keywords
Renal Transplantation, Immunosuppression, Renal transplant recipients, Gastrointestinal symptoms associated with MMF therapy

What participants receive

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

  • Enteric-coated Mycophenolate Acid (EC-MPA)Drug

    Also called myfortic®

  • Mycophenolate Mofetil (MMF)Drug

    Also called CellCept®

  • Placebo MMFDrug

  • Placebo EC-MPADrug

Study groups in NCT00658333
Study groupRoleWhat they receive
Enteric-coated Mycophenolate AcidExperimentalEquimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
Receives: Drug: Enteric-coated Mycophenolate Acid (EC-MPA); Drug: Placebo MMF
Mycophenolate MofetilActive comparatorMycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
Receives: Drug: Mycophenolate Mofetil (MMF); Drug: Placebo EC-MPA

What is being measured

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

  1. Number of Participants With Response (Yes/no)

    The primary variable was the response (yes/no) with positive response being defined as an increase of 360 mg/day enteric-coated mycophenolate acid (MPA)from the baseline daily dose, tolerated and maintained for a 4 week duration until the end of the study (Week 6). Tolerability was defined as the overall assessment of improvement or no change in the intensity of physician assessed gastrointestinal (GI) symptoms at end of study as reported on the physician administered evaluation of GI symptomatology.

    Measured: 6 weeks

Secondary outcomes (1)

  1. Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals

    The average daily doses of enteric-coated mycophenolate acid (MPA) and mycophenolate mofetil (MMF) at baseline and during the last 2 weeks of treatment. 1000 mg MMF = 720 mg enteric-coated MPA (MPA equivalent dose).

    Measured: Baseline and week 4 to week 6

Timeline

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

  1. First posted15 Apr 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionMar 2009
  4. Study completionMar 2009

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00658333
Sponsor's protocol ID
CERL080AUS67
Status last verified
Jul 2012
First submitted
23 Jan 2008
Last updated
7 Aug 2012

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Enteric-coated Mycophenolate Acid (EC-MPA) and Mycophenolate Mofetil (MMF) in people with Renal Transplantation, run by Novartis Pharmaceuticals at 37 sites in United States.

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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States. 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?

Yes. Results are posted in the registry (first posted 11 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Response (Yes/no) (time frame: 6 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 NCT00658333.

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 7 Aug 2012.

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