Budesonide for Mycophenolic Acid-induced Diarrhea in Renal Transplant Recipients

University of Kansas

Status and phase

Terminated

Phase 2

Conditions

Diarrhea

Treatments

Drug: Placebos

Drug: Entocort

Study type

Interventional

Funder types

Other

Identifiers

NCT02991768

STUDY00140436

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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