Renal TransplantationPhase 4NCT00400400
Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
A Phase 4 study testing Enteric-coated mycophenolate sodium (EC-MPS) and Mycophenolate mofetil in people with Renal Transplantation, run by Novartis Pharmaceuticals at 53 sites in United States.
Trial summary
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate… 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 sodium (EC-MPS) and Mycophenolate mofetil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 53 sitesUnited States
- Study dates
- Oct 2006to Jun 2008
- 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
- Males and females aged 18-75 years, Recipients of first or second cadaveric, living unrelated or living related kidney transplant
- Recipients who are at least 4 weeks post renal transplantation with stable renal function, Patients currently receiving MMF (all dosages are allowed) and either cyclosporine USP (MODIFIED) or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 2 weeks prior to study start
- Patients with at least one mild and/or moderate and/or severe upper or lower gastrointestinal (GI) complaints clearly associated with MMF therapy as determined by the treating physician. Additional mild GI complaints may coexist
- Patients' immunosuppressive regimen other than steroids (doses and type) as well as medication for treatment of GI symptoms must be unchanged for at least 1 week prior to study start
- Females of childbearing potential must have a negative pregnancy test prior to the inclusion period. The test should be performed locally at Baseline visit. If positive, the patient will not be included. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication
- Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
Who cannot join
- Multi-organ transplant patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (second kidney transplant is allowed)
- History of GI disorder (diarrhea, Gastroesophageal Reflux Disease (GERD), dyspepsia, Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS) prior to transplantation
- Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MMF, Modification of GI medication or MMF dose within last 1 week
- Evidence of graft rejection, treatment of acute rejection, or unstable renal function within 4 weeks prior to the Baseline visit, Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry
- Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin
- Pregnant or nursing (lactating) women, Women of child-bearing potential (WOCBP) not using an acceptable method of contraception such as: surgical sterilization, hormonal contraception, or double-barrier methods.
- Contraception should be maintained throughout the study and for 4 weeks after study drug discontinuation.
- Other protocol defined inclusion/exclusion criteria may apply.
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Piedmont Hospital
Atlanta, Georgia, 30309
Medical College of Georgia
Augusta, Georgia, 30912
University of Maryland
Baltimore, Maryland, 21201
The Johns Hopkins Hospital
Baltimore, Maryland, 21205
Mid-Atlantic Nephrology Associates
Baltimore, Maryland, 21228
Brigham and Women's Hospital
Boston, Massachusetts, 02115
UNC Chapel Hill
Chapel Hill, North Carolina, 27599-7211
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago Medical Center
Chicago, Illinois, 60637
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
CRSTI
Dallas, Texas, 75230
Denver Nephrology
Denver, Colorado, 80218
University of Colorado Health Science Center
Denver, Colorado, 80262
Henry Ford Health System
Detroit, Michigan, 48202
St. John Hospital Medical Center
Detroit, Michigan, 48236
Baylor All Saints
Fort Worth, Texas, 76104
University of Florida College of Medicine
Gainesville, Florida, 32610-0224
University of Texas Medical Branch
Galveston, Texas, 77555-0533
East Carolina University
Greenville, North Carolina, 27834
Pinnacle Health at Harrisburg Hospital
Harrisburg, Pennsylvania, 17105
Clarian Health Partners
Indianapolis, Indiana, 46202
Univ of KS Medical Ctr
Kansas City, Kansas, 64111
St. Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
University of Kentucky Medical Center
Lexington, Kentucky, 40536
St. Baranabas Medical Center
Livingston, New Jersey, 07039
University of Southern California
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
National Institute of Transplantation
Los Angeles, California, 90057
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Loyola University Medical Center
Maywood, Illinois, 60153
The University of Tennessee Health Science Center
Memphis, Tennessee, 38104
University of Minnesota
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2372
Yale University Transplantation
New Haven, Connecticut, 06520
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
AKDHC Medical Research Services, LLC
Phoenix, Arizona, 85012
Oregon Health & Science University
Portland, Oregon, 97239-3098
Rhode Island Hospital
Providence, Rhode Island, 02903
Virginia Commonwealth University
Richmond, Virginia, 23298
UC Davis Medical Center
Sacramento, California, 95817
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132
University of California San Diego
San Diego, California, 92103-8401
University of California, San Diego
San Diego, California, 92103
University of California
San Francisco, California, 94143
University of Washington
Seattle, Washington, 98195-6521
Northwest Louisiana Nephrology Research
Shreveport, Louisiana, 71101
WKHS/LSUHSC Regional Transplant Center
Shreveport, Louisiana, 71103
Washington University School of Medicine
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
Washington Hospital Transplant Research
Washington D.C., District of Columbia, 20010
Wake Forest
Winston-Salem, North Carolina, 27157
About this study
Official title: A 4-week, Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group Study to Compare the Gastrointestinal Safety and Tolerability of EC-MPS & MMF When Administered in Combination With Calcineurin Inhibitors in Renal Transplant Recipients Experiencing Gastrointestinal Intolerance
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).
- Conditions
- Renal Transplantation
- Being tested
- Enteric-coated mycophenolate sodium (EC-MPS), Mycophenolate mofetil, Placebo to mycophenolate sodium, Placebo to mycophenolate mofetil
- Keywords
- RenalTransplantation, KidneyTransplantation, MPA, EC-MPS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric-coated mycophenolate sodium (EC-MPS)Drug
Also called Myfortic®
Enteric-coated mycophenolate sodium supplied as 180 mg tablets.
Mycophenolate mofetil supplied as 250 mg capsules.
Placebo to mycophenolate sodiumDrug
Placebo to mycophenolate sodium matching tablets.
Placebo to mycophenolate mofetilDrug
Placebo to mycophenolate mofetil matching capsules.
| Study group | Role | What they receive |
|---|---|---|
| Enteric-coated mycophenolate sodium | Experimental | Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study. Receives: Drug: Enteric-coated mycophenolate sodium (EC-MPS); Drug: Placebo to mycophenolate mofetil |
| Mycophenolate mofetil | Active comparator | Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study. Receives: Drug: Mycophenolate mofetil; Drug: Placebo to mycophenolate sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy
Response assessed using the Gastrointestinal Symptom Rating Scale (GSRS), designed to assess common symptoms with gastrointestinal (GI) disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The total score is an average of scores across all 15 items; a higher score indicates more GI symptoms. Response was defined as Day 30 improvement in the GSRS Total Score (change from baseline) of greater than or equal to 0.3. Minimum score is 1; maximum score is 7.
Measured: Baseline, Day 30
Secondary outcomes (6)
Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR)
TAR was defined as an episode of acute rejection that was suspected on clinical grounds and was treated and confirmed by the investigator according to the patient's response to therapy.
BPAR was defined a treated acute rejection that was confirmed by biopsy. A graft core biopsy was performed before or within 24 hours of initiation of anti-rejection therapy and was assessed by the pathologist at the center according to the BANFF 1997 criteria.
Measured: 30 days
Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score
The Severity Score for each GI symptom for each participant was calculated based on the physician's evaluation of current GI symptoms recorded at Baseline and Day 30. For each of the 16 individual GI symptoms the severity score ranged from 0 (absent) to 3 (severe). The Overall Total Score is the Mean of severity ratings of the 16 individual symptoms.
Measured: Baseline, Day 30
Number of Participants With Reported Dose Changes or Interruption of Study Medication During the 30 Days of Treatment
The number of participants with reported dose changes or interruption of study medication during the 30 days of treatment.The most common dose adjustments were dose increases back to baseline levels following a decrease or interruption and decreases due to abnormal laboratory value Adverse Events (leucopenia, thrombocytopenia, neutropenia, or anemia).
Measured: 30 days
Change From Baseline in Lower and Upper GI Symptom Burden Measured by GI Symptom Rating Scale Score
This is reflected by the total score. The total score incorporates lower and upper GI elements. GSRS overall score is the mean of 15 individual GI symptom scores, each rated on a 7- point scale: 1 = no discomfort, 2= minor discomfort, 3 = mild discomfort, 4 = moderate discomfort, 5 = moderately sever discomfort, 6 = severe discomfort and 7 = very severe discomfort. Change from Baseline was calculated using ANCOVA, model includes GSRS, center and treatment group.
Measured: Baseline, Day 30
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
The GSRS has five subscales (reflux, diarrhea, constipation, abdominal pain, indigestion) producing a mean subscale score ranging from 1 (=no discomfort at all) to 7 (very severe discomfort). The mean score at baseline (BL), the mean score at Day 30 and the mean Change from BL to Day 30 is presented for each of the five subscales.
Measured: Baseline to Day 30
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI has 5 different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) that are rated on a 5-point scale from 0 to 4. The individual scores are summed to produce a total score of the 36 items for a total possible score of 0 to 144. Lower scores represent greater dysfunction.
Measured: Baseline, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal TransplantationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400400
- Sponsor's protocol ID
- CERL080AUS51
- Status last verified
- Jul 2011
- First submitted
- 15 Nov 2006
- Last updated
- 15 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week, Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group Study to Compare the Gastrointestinal Safety and Tolerability of EC-MPS & MMF When Administered in Combination With Calcineurin Inhibitors in Renal Transplant Recipients Experiencing Gastrointestinal Intolerance
- ClinicalTrials.gov ID
- NCT00400400
- Acronym / sponsor ID
- CERL080AUS51
- Conditions
- Renal Transplantation
- Keywords
- RenalTransplantation, KidneyTransplantation, MPA, EC-MPS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jun 2008 (actual)
- First posted
- 16 Nov 2006 (estimated)
- Results
- Posted 15 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enteric-coated mycophenolate sodium | Experimental | Drug: Enteric-coated mycophenolate sodium (EC-MPS), Drug: Placebo to mycophenolate mofetilEnteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study. |
| Mycophenolate mofetil | Active comparator | Drug: Mycophenolate mofetil, Drug: Placebo to mycophenolate sodiumMycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females aged 18-75 years, Recipients of first or second cadaveric, living unrelated or living related kidney transplant
- Recipients who are at least 4 weeks post renal transplantation with stable renal function, Patients currently receiving MMF (all dosages are allowed) and either cyclosporine USP (MODIFIED) or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 2 weeks prior to study start
- Patients with at least one mild and/or moderate and/or severe upper or lower gastrointestinal (GI) complaints clearly associated with MMF therapy as determined by the treating physician. Additional mild GI complaints may coexist
- Patients' immunosuppressive regimen other than steroids (doses and type) as well as medication for treatment of GI symptoms must be unchanged for at least 1 week prior to study start
- Females of childbearing potential must have a negative pregnancy test prior to the inclusion period. The test should be performed locally at Baseline visit. If positive, the patient will not be included. Effective contraception must be used during the trial, and for 4 weeks following discontinuation of the study medication
Key exclusion criteria (8 listed)
- Multi-organ transplant patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (second kidney transplant is allowed)
- History of GI disorder (diarrhea, Gastroesophageal Reflux Disease (GERD), dyspepsia, Inflammatory Bowel Disease (IBD) or Irritable Bowel Syndrome (IBS) prior to transplantation
- Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MMF, Modification of GI medication or MMF dose within last 1 week
- Evidence of graft rejection, treatment of acute rejection, or unstable renal function within 4 weeks prior to the Baseline visit, Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry
- Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteric-coated mycophenolate sodium (EC-MPS)Also: Myfortic®Enteric-coated mycophenolate sodium supplied as 180 mg tablets. | Drug | Enteric-coated mycophenolate sodium |
| Mycophenolate mofetilMycophenolate mofetil supplied as 250 mg capsules. | Drug | Mycophenolate mofetil |
| Placebo to mycophenolate sodiumPlacebo to mycophenolate sodium matching tablets. | Drug | Mycophenolate mofetil |
| Placebo to mycophenolate mofetilPlacebo to mycophenolate mofetil matching capsules. | Drug | Enteric-coated mycophenolate sodium |
Primary outcome
The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy
Time frame: Baseline, Day 30
Response assessed using the Gastrointestinal Symptom Rating Scale (GSRS), designed to assess common symptoms with gastrointestinal (GI) disorders. The GSRS has 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). The total score is an average of scores across all 15 items; a higher score indicates more GI symptoms. Response was defined as Day 30 improvement in the GSRS Total Score (change from baseline) of greater than or equal to 0.3. Minimum score is 1; maximum score is 7.
6 secondary outcomes
Number of Participants With Biopsy-proven Acute Rejection (BPAR) and Treated Acute Rejection (TAR)
Time frame: 30 days
Change From Baseline to Day 30 in the Severity of Gastrointestinal Symptoms Overall Total Score
Time frame: Baseline, Day 30
Number of Participants With Reported Dose Changes or Interruption of Study Medication During the 30 Days of Treatment
Time frame: 30 days
Change From Baseline in Lower and Upper GI Symptom Burden Measured by GI Symptom Rating Scale Score
Time frame: Baseline, Day 30
Change in Gastrointestinal Symptom Rating Scale Subscale Scores After 30 Days of Treatment
Time frame: Baseline to Day 30
Change From Baseline (BL) to Day 30 in the Gastrointestinal Quality of Life Index (GIQLI) Total Score and Subscale Scores
Time frame: Baseline, Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis study director
Novartis
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enteric-coated mycophenolate sodium (EC-MPS) and Mycophenolate mofetil in people with Renal Transplantation, run by Novartis Pharmaceuticals at 53 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 6 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: finished, as of the sponsor's last update on 15 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 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 15 Aug 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?
The Number of Participants Who Responded to the Conversion to Mycophenolate Sodium (EC-MPS) Therapy (time frame: Baseline, Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2011; AzTrials last refreshed its copy on 26 Oct 2026.