EUCTR2018-001303-36-IT进行中（未招募）1 期
A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis - VALOR-CKD
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,000
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. Male or female subjects 18 to 85 years of age, inclusive.
- •2. The mean of two Screening eGFR measurements, drawn at least 2 weeks apart and both within 6 weeks of the first day of Part A, is 20 to 40 mL/min/1.73m2, inclusive.
- •3. Have stable renal function as defined by eGFR Screening values that are not different by > 20% (the higher of the two Screening eGFR values will be used as the denominator to calculate the 20% allowable difference)
- •4. Based on onsite measurement using an iSTAT point of care device, have three serum bicarbonate values, each >= 2 weeks apart from each other and all within 6 weeks of the A1 Visit, in the range from 12 to 20 mEq/L, inclusive.
- •5. Mean systolic and diastolic blood pressure (determined as the average of three replicates) must be < 160/92 mmHg at the Screening 2 Visit.
- •6. Receiving treatment with an ACE inhibitor and/or ARB at the maximum tolerated (for the individual subject) dose within the country-specific labeled dose range, without adjustments, for >= 4 weeks prior to the Screening 1 Visit and during the Screening Period.
- •7. If receiving an oral alkali supplement, the dose must be stable for >= 2 weeks prior to Screening 1 Visit and during the Screening Period. If not receiving alkali treatment, there must be no such treatment within the 2 weeks prior to Screening 1 Visit or during the Screening Period.
- •8. Have a hemoglobin A1c (HbA1c) value of <= 11.0% (0.11 fraction; 97 mmol/mol) at the Screening 1 Visit.
- •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 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1000
排除标准
- •1. Have any level of low serum 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, or acute kidney injury/acute renal failure in the 3 months prior to the Screening 1 Visit.
- •3. Had heart failure with maximum New York Heart Association (NYHA) Class IV symptoms during the 3 months prior to the Screening 1 Visit.
- •4. Had a heart, liver or kidney transplant.
- •5. Have an ileostomy or colostomy or have had a bowel resection or bariatric surgery. Subjects who have had gastric lap band procedures (no gastric resection) are allowed.
- •6. Have a corrected serum calcium < 8.0 mg/dL (80 mg/L; 2 mmol/L) at the Screening 1 Visit, based on central laboratory measurement.
研究者
相似试验
进行中（未招募）
1 期
Effects of a medication being studied (rilematovir) in infants and children and subsequently neonates in the hospital with a respiratory infection due to RSVRespiratory Syncytial VirusMedDRA version: 21.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-002023-11-HUJanssen-Cilag International NV737
进行中（未招募）
1 期
Efficacy and safety of adding LX4211 (an investigational oral compound) for patients with Type 1 Diabetes Mellitus (T1D) who have inadequate control of their blood glucose (sugar) levels on insulin alone.Type 1 Diabetes MellitusEUCTR2014-005153-39-LTexicon Pharmaceuticals, Inc.750
进行中（未招募）
1 期
Effects of a medication being studied (rilematovir) in infants and children and subsequently neonates in the hospital with a respiratory infection due to RSVEUCTR2020-002023-11-SEJanssen-Cilag International NV737
进行中（未招募）
1 期
A Study of the Effects of AMG 334 to Prevent Migraine HeadachesEUCTR2014-004464-38-NLAmgen Inc852
进行中（未招募）
1 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)Immunoglobulin A Nephropathy (IgAN)EUCTR2020-003084-26-CZChinook Therapeutics U.S., Inc.320