Conditions: Gastrointestinal Lesions Signs and Symptoms, Digestive
Keywords: Renal transplant recipients Gastrointestinal findings in small bowel capsule endoscopy Mycophenolic acid Mycophenolate Mofetil Mycophenolate Sodium
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 23
Healthy volunteers: no

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.

Arms:
arm 1: 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: intervention 1: Small bowel capsule endoscopy (SBCE) intervention 2: myfortic
Intervention descriptions: intervention 1: SBCE will be performed at Day 2 and Day 30. intervention 2: switching from mycophenolate mofetil to mycophenolic acid on equimolar basis

Protocol document: