Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

• Status: Terminated
• Trial end date: 2019-04-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to learn if using a Entocort (budesonide) to treat diarrhea will be effective and safe for kidney transplant patients, allowing them to continue with MPA medication.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pooja Budhiraja, MD
• Treatments: Budesonide; Mycophenolic Acid

Criteria

Inclusion Criteria:

• Kidney transplant recipients > 1 months post-transplant,

• No history of chronic diarrhea pre-transplant,

• >3 watery/soft stools after transplant on at least 4 days in the week without anti-diarrheal for at least 2 weeks or using anti-diarrheals for at least 4 days in the week > 2 weeks

• Subjects on at least 180mg twice a day of mycophenolate-sodium or 250 mg twice a day of cellcept

Exclusion Criteria:

• Diagnosis of any known colonic diseases (i.e. Crohn's disease, ulcerative colitis, ischemic colitis, Celiac disease), partial colonic resection, small bowel resection, history of cholecystectomy, Irritable Bowel Syndrome, fecal Incontinence, Bacterial overgrowth, infectious diarrhea (c difficle, cryptospora, giardia, isospora, Human Immunodeficiency Virus), Cytomegalovirus colitis

• Subjects with recent acute rejection treated with high dose steroids

• Subjects taking Boswellia serrata extract, over-the-counter herbs, cholestyramine, nonsteroidal salicylates (other than daily ASA)

• Subjects with active malignancy, liver cirrhosis, active peptic ulcer disease, known intolerance or resistance to budesonide, pregnancy, breast-feeding, mental retardation

• Unable to provide informed consent