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Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®

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ClinicalTrials.gov Identifier: NCT00652834
Recruitment Status : Completed
First Posted : April 4, 2008
Results First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Suphamai Bunnapradist, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE April 1, 2008
First Posted Date  ICMJE April 4, 2008
Results First Submitted Date  ICMJE December 2, 2014
Results First Posted Date  ICMJE March 4, 2016
Last Update Posted Date March 4, 2016
Study Start Date  ICMJE April 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2016)
GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score [ Time Frame: one month ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
This study aims at providing evidence gastrointestinal mucosal findings in patients receiving MMF and improvement of that findings after conversion from MMF to Myfortic® as demonstrated by SBCE. [ Time Frame: one month ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
To demonstrate the improvement of gastrointestinal symptoms after conversion to Myfortic® from MMF therapy. [ Time Frame: one month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®
Official Title  ICMJE Gastrointestinal Mucosal Findings in Patients Receiving Mycophenolic Acid (MPA) as Demonstrated by Small Bowel Capsule Endoscopy (SBCE)
Brief Summary 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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastrointestinal Lesions
  • Signs and Symptoms, Digestive
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Procedure: Small bowel capsule endoscopy (SBCE)
  • Drug: myfortic
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2016)
23
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2008)
20
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00652834
Other Study ID Numbers  ICMJE 11-001911
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Suphamai Bunnapradist, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: suphamai bunnapradist, MD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP