- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00652834
Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®
February 5, 2016 updated by: Suphamai Bunnapradist, University of California, Los Angeles
Gastrointestinal Mucosal Findings in Patients Receiving Mycophenolic Acid (MPA) as Demonstrated by Small Bowel Capsule Endoscopy (SBCE)
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).
Study Overview
Status
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
23
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- University of California, Los Angeles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
SBCE will be performed at Day 2 and Day 30.
Other Names:
switching from mycophenolate mofetil to mycophenolic acid on equimolar basis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: suphamai bunnapradist, MD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Behrend M. Adverse gastrointestinal effects of mycophenolate mofetil: aetiology, incidence and management. Drug Saf. 2001;24(9):645-63. doi: 10.2165/00002018-200124090-00002.
- Shaw LM, Sollinger HW, Halloran P, Morris RE, Yatscoff RW, Ransom J, Tsina I, Keown P, Holt DW, Lieberman R, et al. Mycophenolate mofetil: a report of the consensus panel. Ther Drug Monit. 1995 Dec;17(6):690-9. doi: 10.1097/00007691-199512000-00025. No abstract available.
- Ojo AO, Meier-Kriesche HU, Hanson JA, Leichtman AB, Cibrik D, Magee JC, Wolfe RA, Agodoa LY, Kaplan B. Mycophenolate mofetil reduces late renal allograft loss independent of acute rejection. Transplantation. 2000 Jun 15;69(11):2405-9. doi: 10.1097/00007890-200006150-00033.
- Meier-Kriesche HU, Steffen BJ, Hochberg AM, Gordon RD, Liebman MN, Morris JA, Kaplan B. Long-term use of mycophenolate mofetil is associated with a reduction in the incidence and risk of late rejection. Am J Transplant. 2003 Jan;3(1):68-73. doi: 10.1034/j.1600-6143.2003.30112.x.
- Salvadori M, Holzer H, de Mattos A, Sollinger H, Arns W, Oppenheimer F, Maca J, Hall M; ERL B301 Study Groups. Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. Am J Transplant. 2004 Feb;4(2):231-6. doi: 10.1046/j.1600-6143.2003.00337.x.
- Dimenas E, Carlsson G, Glise H, Israelsson B, Wiklund I. Relevance of norm values as part of the documentation of quality of life instruments for use in upper gastrointestinal disease. Scand J Gastroenterol Suppl. 1996;221:8-13. doi: 10.3109/00365529609095544.
- Kleinman L, Faull R, Walker R, Ramesh Prasad GV, Ambuehl P, Bahner U. Gastrointestinal-specific patient-reported outcome instruments differentiate between renal transplant patients with or without GI complications. Transplant Proc. 2005 Mar;37(2):846-9. doi: 10.1016/j.transproceed.2004.12.106.
- Bunnapradist S, Sampaio MS, Wilkinson AH, Pham PT, Huang E, Kuo HT, Anastasi B, Danovitch GM, Lo SK. Changes in the small bowel of symptomatic kidney transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium. Am J Nephrol. 2014;40(2):184-90. doi: 10.1159/000365360. Epub 2014 Sep 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
April 1, 2008
First Submitted That Met QC Criteria
April 3, 2008
First Posted (Estimate)
April 4, 2008
Study Record Updates
Last Update Posted (Estimate)
March 4, 2016
Last Update Submitted That Met QC Criteria
February 5, 2016
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-001911
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Signs and Symptoms, Digestive
-
Seed HealthCurebase Inc.CompletedConstipation | Signs and Symptoms | Digestive Signs and Symptoms | Infrequent or Difficult EvacuationUnited States
-
AB Biotics, SACompleted
-
Kyowa Kirin Pharmaceutical Development LtdCompletedConstipation, Signs and Symptoms, DigestiveUnited Kingdom, Denmark, Norway, Israel, Spain
-
Children's Mercy Hospital Kansas CityTerminated
-
Centers for Disease Control and PreventionProcter and Gamble; Health Oriented Preventive EducationCompleted
-
U.S. Army Medical Research and Development CommandWithdrawnDiarrheaUnited States
-
Forest LaboratoriesCompleted
-
Microbiome Health SciencesCompleted
-
University of MalayaSecond Affiliated Hospital, School of Medicine, Zhejiang University; Zhejiang...Unknown
Clinical Trials on Small bowel capsule endoscopy (SBCE)
-
University Hospital FreiburgRecruitingGastroIntestinal BleedingGermany
-
Nantes University HospitalRecruiting
-
Odense University HospitalCompletedSimulation | Endoscopy | Education | Small Bowel Disease | Small Bowel Capsule EndoscopyDenmark
-
University of Southern CaliforniaCompletedObscure Gastrointestinal Bleeding (Occult or Overt)United States
-
Mayo ClinicMedtronic - MITGCompletedCrohn's DiseaseUnited States
-
Asian Institute of Gastroenterology, IndiaCompletedSmall Bowel Disease | Small Bowel Ulcers | Capsule Endoscopy | Small Bowel Tumor
-
Western Sydney Local Health DistrictWestmead hospital Westmead NSW 2145 AustraliaCompleted
-
Sygehus LillebaeltOdense University Hospital; Hospital of South West JutlandCompleted
-
Mayo ClinicJuvenile Diabetes Research Foundation; University of Chicago; Harvard UniversityCompletedType 1 DiabetesUnited States
-
University Medical Center GroningenMaastricht University Medical Center; Erasmus Medical Center; Medtronic - MITG; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) and other collaboratorsCompletedLynch Syndrome | Small Bowel NeoplasiaNetherlands