NCT02991768终止2 期
Budesonide for Mycophenolic Acid (MPA)-Induced Diarrhea in Renal Transplant Recipients
Pooja Budhiraja, MD1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2017年1月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Complete Remission of Diarrhea
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Entocort EC
Experimental
Subjects will take 6mg Entocort EC by mouth daily for 8 weeks.
干预措施: Entocort (Drug)
Placebo
Placebo Comparator
Subjects will take 6mg matching placebo pill daily for 8 weeks.
干预措施: Placebos (Drug)
结局指标
主要结局
Complete Remission of Diarrhea
时间窗: Week 8
Measured using symptom diary. Complete remission (CR) is defined as a mean of \<3 stools/day and a mean of \<1 watery stool per day without use of anti-diarrheal drugs.
次要结局
- Change in Gastrointestinal Symptom Rating Scale (GSRS)(Change from Baseline to Week 16)
- Change in Gastrointestinal Quality of Life Index (GIQLI)(Change from Baseline to Week 16)
- MPA Dose(Change from Baseline to Week 16)
研究者
Pooja Budhiraja, MD
Assistant Professor
University of Kansas Medical Center
研究点 (1)
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