EUCTR2017-002562-42-SI进行中（未招募）1 期
A Blinded, Placebo-Controlled Extension to Study TRCA-301 to Evaluate the Long-term Safety and Durability of Effect of TRC101 in Subjects with Chronic Kidney Disease and Metabolic Acidosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 196
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Have provided written informed consent prior to participation in the study.
- •2.Have completed the 12-week treatment period and attended the Week 12 Visit in the parent study TRCA-301.
- •3.Have a blood bicarbonate value of = 12 mEq/L at the Week 12 Visit in Study TRCA-301, based on onsite measurement using the i-STAT point-of-care device.
- •4.Have adequate peripheral venous access for blood draws.
- •5.Women who are of childbearing potential must have negative pregnancy test at the Week 12 Visit and be willing to use an acceptable method of birth control until 1 month after study completion. Acceptable methods include hormonal contraception (oral contraceptives, patch, implant, and injection), intrauterine devices, double barrier methods (e.g., vaginal diaphragm, vaginal sponge, condom, spermicidal jelly), sexual abstinence or a vasectomized partner. Women who are surgically sterile with documentation of such, or who are at least 1-year post-last menstrual period and > 55 years of age, are considered not to be of childbearing potential.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 105
排除标准
- •1.Have any level of low blood bicarbonate at the Week 12 Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
- •2.Required dialysis for acute kidney injury or worsening CKD during the parent study TRCA-301.
- •3.Planned initiation of renal replacement therapy (dialysis or transplantation) within 6 months following study entry.
- •4.Have a history or current diagnosis of clinically significant diabetic gastroparesis (based on Investigator’s judgment) or a history of bariatric surgery.
- •5.Have a history or current diagnosis of bowel obstruction, swallowing disorders, severe gastrointestinal (GI) disorders, inflammatory bowel disease, major GI surgery, or active gastric/duodenal ulcers.
- •6.Have a serum calcium = 8.0 mg/dL at the Week 10 Visit in the parent study, TRCA-301.
- •7.Have active cancer during the 1 year prior to the Week 12 Visit, other than non-melanoma skin cancer, or cancer that is currently being treated or will be treated during the study. Subjects with cancers that are being treated with hormonal therapy only may be permitted with approval of the Medical Monitor.
- •8.Inability to consume the study drug, known allergy to the study drug or otherwise comply with the protocol.
- •9.Have, in the opinion of the Investigator, any medical condition, uncontrolled systemic disease or serious concurrent illness that would significantly decrease study compliance or jeopardize the safety of the subject or affect the validity of the study results.
研究者
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