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Gastrointestinal and Health-related Quality of Life in Kidney Transplant Patients Treated With Mycophenolate Mofetil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400647
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : February 7, 2017
Information provided by (Responsible Party):

Brief Summary:

This study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will also access the relationship between mycophenolic acid (MPA) dose in those patients receiving enteric-coated mycophenolate sodium formulation(EC-MPS).

Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then again at 12 weeks post-conversion.

Condition or disease Intervention/treatment Phase
Maintenance Kidney Transplant Drug: Enteric-coated Mycophenolate sodium (EC-MPS) Drug: Mycophenolate mofetil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A 12-week Multicenter, Randomized, Open Study to Evaluate the Effects of Enteric-coated Mycophenolate Sodium (EC-MPS) in Terms of Quality of Life in Patients With Gastrointestinal (GI) Symptoms Treated With MMF (Mycophenolate Mofetil) After Kidney Transplant.
Study Start Date : July 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Arm Intervention/treatment
Experimental: EC MPS
Up to 1440mg taken in two doses
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
Active Comparator: Mycophenolate mofetil
250 mg or 500 mg in two equal doses
Drug: Mycophenolate mofetil

Primary Outcome Measures :
  1. To determine the effect of the use of EC-MPS on the quality of life of patients requiring MMF dose reduction due to gastrointestinal symptoms [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. To determine whether EC-MPS enables the administration of higher doses with good tolerability, compared with standard MMF treatment, in patients with shown susceptibility to undesirable GI effects [ Time Frame: 12 weeks ]
  2. To measure health-related quality of life (HRQOL) through the GI quality of life index (GIQLI) and the psychological general well-being index (PGWB) [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  1. Patients who are recipients of a renal transplant.
  2. Patients treated with an immunosuppressive regiment including MMF before recruitment.
  3. Patients suffering from GI side effects related to MMF standard doses or patients treated with a reduced MMF dose to control the aforementioned GI side effects.
  4. Patients 18 years or older.
  5. Patients who have given written informed consent to participate in the study
  6. Patients complying with all study requirements including completing questionnaires and attending to the three study visits.

Exclusion criteria

  1. Patients with GI symptoms assumed or known not to be caused by MPA therapy (eg. oral bisphosphonate induced, infectious diarrhea)
  2. Acute rejection less than 1 week before recruitment.
  3. Females of childbearing potential who are pregnant, planning to get pregnant and/or breast feeding or not willing to practice an approved method of birth control.
  4. Presence of psychiatric disorder, such as schizophrenia or major depression, in the investigator's opinion, could interfere with study requirements.
  5. Patients undergoing surgery due to acute illness or hospitalized.
  6. Existence of any medical condition which, in the investigator's opinion based on anamnesis or medical records, could affect study completion, including but not limiting visual problems or cognitive deterioration.
  7. Patients currently treated or who have been treated with any other study drug or treatment within 30 days prior to baseline visit.

Other protocol-defined inclusion/exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400647

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Basel, Switzerland
Sponsors and Collaborators
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Study Director: Novartis Novartis
Additional Information:
Publications of Results:
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Responsible Party: Novartis Identifier: NCT00400647    
Other Study ID Numbers: CERL080AES06
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Keywords provided by Novartis:
kidney transplant
enteric-coated mycophenolate sodium
quality of life
gastrointestinal symptoms
Additional relevant MeSH terms:
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Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action