Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Suphamai Bunnapradist, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00652834
First received: April 1, 2008
Last updated: February 5, 2016
Last verified: December 2014
  Purpose
The purpose of this study is to learn more about symptoms and gastrointestinal lesions associated with taking myfortic® by switching patients to a delayed release formulation that is developed to alleviate GI symptoms. A comparison of the frequency and severity of GI symptoms observed in patients treated with MMF (cellcept®) after conversion to myfortic® will be measured by using a self-assessed questionnaire called Gastrointestinal Symptom Rating Scale (GSRS). To prove the incidence and improvement of GI lesions in patients treated with MMF (cellcept®) after conversion to myfortic® will be measured by using Small Bowel Capsule Endoscopy (SBCE).

Condition Intervention Phase
Gastrointestinal Lesions
Signs and Symptoms, Digestive
Procedure: Small bowel capsule endoscopy (SBCE)
Drug: myfortic
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gastrointestinal Mucosal Findings in Patients Receiving Mycophenolic Acid (MPA) as Demonstrated by Small Bowel Capsule Endoscopy (SBCE)

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score [ Time Frame: one month ] [ Designated as safety issue: No ]

    The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.

    A higher GSRS indicate worse symptoms and a difference between D30 and last SBCE scores greater or equal to 0.3 can be considered as a clinically significant improvement in the symptoms.



Enrollment: 23
Study Start Date: April 2009
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
kidney recipients with GI symptoms
This was a four-week study designed to investigate GI mucosal lesions by SBCE in kidney transplant recipients who were using MMF, and to examine the changes in clinical symptoms and intestinal mucosa lesions 30 days after switching over from MMF to EC-MPS. The patient was switched from MMF to EC-MPS (Myfortic) on the equimola basis.
Procedure: Small bowel capsule endoscopy (SBCE)
SBCE will be performed at Day 2 and Day 30.
Other Name: PillCamEso
Drug: myfortic
switching from mycophenolate mofetil to mycophenolic acid on equimolar basis
Other Name: EC-MPS

Detailed Description:
Myfortic® recently introduced to the market has shown to be similar to MMF in how effectively it works and how well it is tolerated. Both drugs have the same active ingredient, but they are different in the way that they deliver them to the body. Myfortic® is an advanced, enteric coated formulation of mycophenolate sodium (EC-MPS) that delays the release of the active ingredient, MPA. MPA has more potent effects on the lymphocytes than other cells. This makes for improved GI tolerability of the MPA therapy.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female patients between 18 and 75 years of age.
  • 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 who have used MMF at least 10 days and are currently receiving MMF. (up to 3g/day dosage allowed)
  • Patients with at least one moderate or severe upper or lower GI complaints.
  • Patients' immunosuppressive regimen other than steroids 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. 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.

Exclusion Criteria:

  • Multi-organ transplant patients or previous transplant with any other organ different from kidney.
  • The presence of a severe GI disorder. History of a significant GI disorder prior to transplant that has remained unchanged since transplant and/or the introduction of MMF will exclude patient.
  • 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 women.
  • Patients with thrombocytopenia (<75,000/mm3), with an absolute neutrophil count of <1,500/mm3 and/or leukocytopenia (<3,500/mm3), and/or hemoglobin <9.0 g/dL prior to enrollment.
  • Presence of clinically significant pyrexia and/or infection requiring continued therapy.
  • Evidence of severe liver disease [incl. abnormal liver profile i.e. AST, ALT or total bilirubin = 3 times the upper limit of normal].
  • Patients who have any anatomical GI tract defects which have risk of capsule getting stuck such as tumor or previous abdominal surgery.
  • Abnormal physical or laboratory findings of clinical significance within 2 weeks of inclusion which would interfere with the objectives of the study.
  • Patients with symptoms of significant illness or evidence of current drug and/or alcohol abuse.
  • Inability to self-administer the GSRS & OTE questionnaire.
  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
  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: NCT00652834

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Novartis
Investigators
Principal Investigator: suphamai bunnapradist, MD University of California, Los Angeles
  More Information

Publications:

Responsible Party: Suphamai Bunnapradist, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00652834     History of Changes
Other Study ID Numbers: 11-001911 
Study First Received: April 1, 2008
Results First Received: December 2, 2014
Last Updated: February 5, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Renal transplant recipients
Gastrointestinal findings in small bowel capsule endoscopy
Mycophenolic acid
Mycophenolate Mofetil
Mycophenolate Sodium

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016