Small Bowel Capsule Endoscopy Findings in Patients Receiving Cellcept®

NCT00652834 | Completed Phase 4 Results

• 1 other identifier: 11-001911
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastrointestinal Lesions; Signs and Symptoms, Digestive

Keywords

Renal transplant recipients; Gastrointestinal findings in small bowel capsule endoscopy; Mycophenolic acid; Mycophenolate Mofetil; Mycophenolate Sodium

Outcome Measures

Primary Outcomes (1)

• GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score

  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

Study Arms (1)

kidney recipients with GI symptoms

OTHER

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); Drug: myfortic

Interventions

Small bowel capsule endoscopy (SBCE) PROCEDURE

SBCE will be performed at Day 2 and Day 30.

Also known as: PillCamEso

kidney recipients with GI symptoms

myfortic DRUG

switching from mycophenolate mofetil to mycophenolic acid on equimolar basis

Also known as: EC-MPS

kidney recipients with GI symptoms

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Novartis: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (8)

• 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.

  PMID: 8588243 BACKGROUND

• 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.

  PMID: 10868649 BACKGROUND

• 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.

  PMID: 12492713 BACKGROUND

• 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.

  PMID: 11522119 BACKGROUND

• 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.

  PMID: 14974944 BACKGROUND

• 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.

  PMID: 9110389 BACKGROUND

• 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.

  PMID: 15848552 BACKGROUND

• 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.

  PMID: 25196230 RESULT

MeSH Terms

Conditions

Signs and Symptoms, Digestive

Interventions

Endoscopy; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Limitations and Caveats

We did not enroll asymptomatic patients and in the extension of the trial the number of patients re-examined were few and the data obtained from them are not enough to provide definitive information.

Results Point of Contact

• Title: Dr. Bunnapradist
• Organization: UCLA Kidney Transplant Research Program

bunnapradist@mednet.ucla.edu

310-794-8516

Study Officials

• suphamai bunnapradist, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: April 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 4, 2016
• Results First Posted: March 4, 2016

Record last verified: 2014-12

Locations

US (1)