CTRI/2022/11/047767暂停2 期
A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial to Evaluate Safety and Efficacy of US-APR2020 in Subjects With Chronic Kidney Disease Stage IV
Kibow Biotech Inc0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Adults between the ages of 18–80 years
- •2.CKD Stage IV with decling kidney function for a period more than 6 months
- •3.Serum Creatinine more than 2.0 mg/mL
- •4.Adherence to low protein diet (LPD) of 0.6–0.8 g/kg/day based on subject response and on advisory
排除标准
- •1.Those on probiotic supplements in the past 3 months
- •2.Pregnancy, breast feeding or females of child-bearing potential who are unwilling to use a reliable form of contraception.
- •3.Immunosuppressant medications therapy specific to immune mediated renal diseases
- •4.HIV/AIDs
- •5.Underweight (BMI = 18.5)
- •6.Subject with an infection that requires oral antibiotic administration at the time of randomization or close to that visit.
- •7.Those with gastrointestinal disease (irritable bowel syndrome or anal fissures or anal fistulas or perianal abscesses or perianal infections or diverticular diseases or colitis or colon polyps) at the time of screening and randomization, or within 6 months prior to the randomization visit (Visit 2)
- •8.Those with internal prosthesis including orthopedics, neurosurgery, heart valves, vascular stents ? 2 years post -surgery procedure. Those with Prosthesis > 2 years should not be excluded.
- •9.Those with biological/tissue grafts or prosthesis or implant
- •10.Those on anticoagulant medicines, including Vit K antagonists (e.g., warfarin, coumadin) or the new class of oral anti-coagulants approved by FDA in the last 10 years
- •11.Those on peritoneal dialysis
- •12.Those with acute kidney injury
- •13.Those with mental conditions or medically debilitating disease/disorder other than CKD, which, in the judgment of the investigator, would interfere with or serve as a contraindication to adherence to the study protocol or affect the ability to give informed consent or affect overall prognosis of the patient.
研究者
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