EUCTR2016-003825-41-HR进行中（未招募）1 期
A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety 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
- 210
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.Male or female subjects 18 to 85 years of age at the Screening 1 Visit.
- •3.Have a blood bicarbonate value of 12 to 20 mEq/L at Screening 1 and Screening 2 Visits AND an average value for Screening 1, Screening 2, and Baseline Visits (i.e., baseline blood bicarbonate) within the range 12 to 20 mEq/L based on onsite measurement using an i-STAT point of care device.
- •Screening 1 and Screening 2 Visits must be at least 5 days apart.
- •Note: Subjects with baseline blood bicarbonate values of 12 to 18 mEq/L are eligible without restriction. Once 105 subjects with baseline blood bicarbonate values of > 18 to 20 mEq/L have been enrolled, randomization may be closed to additional subjects with baseline blood bicarbonate in this range.
- •4.At both Screening Visits have an eGFR value of 20 to 40 mL/min/1.73m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation as reported by the central laboratory. If a central laboratory eGFR value at Screening 2 Visit is not available, eGFR can be calculated using CKD EPI equation based on onsite serum creatinine measurement at the Baseline Visit to establish subject’s eligibility.
- •Screening 1 and Screening 2 Visits must be at least 5 days apart.
- •5.Have stable renal function as defined by eGFR values at both Screening Visits that are not different by more than 20% (the higher of the two Screening eGFR values will be used as the denominator to calculate the 20% allowable difference).
- •6.At both Screening Visits have systolic blood pressure < 170 mmHg (all three replicates).
- •7.Have a hemoglobin A1c (HbA1c) value of = 9.0% at the Screening 1 Visit based on central laboratory measurement.
- •8.Have adequate peripheral venous access for blood draws.
- •9.Women who are of childbearing potential must have negative pregnancy tests at the Screening 1 Visit and Day 1 and be willing to use an acceptable method of birth control from the Screening 1 Visit 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 either Screening Visit that, in the opinion of the Investigator, requires emergency intervention or evaluation for an acute acidotic process.
- •2.Have had anuria, dialysis, acute kidney injury, history of acute renal insufficiency or known = 30% increase in serum creatinine or known = 30% acute or chronic decrease in eGFR in the 3 months prior to the Screening 1 Visit.
- •3.Have chronic obstructive pulmonary disease (COPD) that is treated with chronic oral steroids, that requires the subject to be on oxygen, or that required hospitalization within the previous 6 months.
- •4.Had heart failure with maximum New York Heart Association (NYHA) Class IV symptoms, or that required hospitalization with a primary cause of heart failure, during the preceding 6 months (see Append 3).
- •5.Have had a heart or kidney transplant.
- •Note: Patients on the cadaveric transplant list or being evaluated for a future living donor transplant may be enrolled.
- •6.Planned initiation of renal replacement therapy (dialysis or transplantation) within 12 weeks following randomization.
- •7.Have had a stroke or transient ischemic attack (TIA) within the 6 months prior to randomization.
- •8.Have had a cardiac event within 12 weeks prior to randomization, including: myocardial infarction, acute coronary syndrome, coronary bypass grafting, percutaneous coronary intervention, valve procedure, inpatient or outpatient treatment for acute decompensated heart failure.
- •9.Have been hospitalized for any reason during the 2 months prior to the Screening 1 Visit, other than for pre-planned diagnostic or minor invasive procedures. Note: Subjects who had major CV procedures or percutaneous cardiac procedures during this time frame are excluded, even if the procedures were pre planned.
- •10.Have a history or current diagnosis of clinically significant diabetic gastroparesis (based on Investigator’s judgment) or a history of bariatric surgery.
- •11.Have a history or current diagnosis of bowel obstruction, swallowing disorders, severe GI disorders, inflammatory bowel disease, major GI surgery, frequent diarrhea or active gastric/duodenal ulcers.
- •12.Have liver enzyme (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) or total bilirubin values > 3 × the upper limit of normal (ULN) at Screening based on central laboratory measurements.
- •13.Have a serum calcium = 8.0 mg/dL at the Screening 1 Visit based on central laboratory measurement.
- •14.Have a serum potassium value < 3.8 mEq/L or > 5.9 mEq/L at the Screening 1 or Screening 2 Visit.
- •15.Have active cancer during the 1 year prior to Screening, 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.
- •16.Have received any investigational medication during the last month (28 days or = 5 half-lives [if known], whichever is longer) preceding the Screening 1 Visit.
- •17.Have used any of the following in the 14 days prior to the Screening 1 Visit: lanthanum carbonate, colesevelam, cholestyramine or sodium or calcium polystyrene sulfonate, calcium acetate, sevelamer, bixalomer, patiromer, and other polymeric binder drugs.
- •18.Have had a change in doses (including starting or stopping treatment) in the 2 weeks prior to the Screening 1 Visit or during Screening Period to the following: calcium-containing su
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