EUCTR2021-001519-10-ES进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Lumasiran in Patients with Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Age 18 years or older (or age of legal consent, whichever is older).
- •Recurrent kidney stone disease, defined as =2 stone events within the 5 years prior to screening. For inclusion, a historical kidney stone event is defined as:
- •1. the visible passage of a kidney stone
- •2. a procedural intervention for removal of an asymptomatic or symptomatic stone
- •3. a new (=1 mm) or enlarged (by =2 mm) kidney stone on CT imaging
- •The 2 most recently analyzed kidney stones prior to randomization contained 50% or more of calcium oxalate; if only one stone analysis is available, then it must have contained 50% or more of calcium oxalate.
- •24-hour urinary oxalate levels from 2 valid 24-hour urine collections obtained during screening are >ULN.
- •Willing to adhere to dietary recommendations appropriate for stone formers including limiting vitamin C supplementation to <200 mg daily.
- •If taking medications and/or hydrating for kidney stone prophylaxis, or taking medications that alter urinary oxalate excretion and/or kidney stone formation, must have been on a stable regimen for at least 60 days before randomization, and willing to remain on this stable regimen for the duration of the study.
- •Body mass index (the weight in kilograms divided by the square of the height in meters) of 20 to <40 kg/m2.
- •Patient is able to understand and is willing and able to comply with the study requirements and to provide written informed consent.
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Has any of the following laboratory parameter assessments at screening:
- •a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × ULN
- •b. Total bilirubin >1.5 × ULN. Patients with elevated total bilirubin that is secondary to documented Gilbert’s syndrome are eligible if the total bilirubin is <2 × ULN
- •c. International normalized ratio (INR) >2.0 (patients on oral anticoagulant [eg, warfarin] with an INR <3.5 will be allowed)
- •Has an eGFR of <30 mL/min/1.73m2 at screening (calculation will be based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] creatinine formula;
- •Received an investigational agent within the last 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug, or are in follow-up of another clinical study prior to study enrollment
- •Patients with a known history of secondary causes of elevated urinary oxalate and/or recurrent kidney stones including:
- •a. Primary hyperoxaluria
- •b. Severe eating disorders (anorexia or bulimia)
- •c. Chronic inflammatory bowel disease
- •d. Intestinal surgery with malabsorption or chronic diarrhea
- •e. Sarcoidosis
- •f. Primary hyperparathyroidism
- •g. Complete distal renal tubular acidosis
- •Has other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation.
- •History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc.
- •History of intolerance to SC injection(s)
- •Is not willing to comply with the contraceptive requirements during the study period
- •Female patient is pregnant, planning a pregnancy, or breast-feeding
- •Unwilling or unable to limit alcohol consumption throughout the course of the study
- •History of alcohol abuse, within the last 12 months before screening, in the opinion of the Investigator.
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