EUCTR2018-000921-29-IT进行中（未招募）1 期
Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients with Enteric Hyperoxaluria: A Phase III Randomized, DoubleBlind, Placebo-Controlled Study (URIROX-2) - NA
ALLENA PHARMACEUTICALS INCORPORATED0 个研究点目标入组 500 人开始时间: 2021年6月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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.Has signed and dated the Institutional Review Board (IRB)/Ethics Committee (EC approved informed consent form (ICF) before undergoing any Screening procedure
- •2.Is >= 18 years of age at Screening
- •3.Has an underlying enteric disorder associated with malabsorption (e.g., malabsorptive bariatric surgery a minimum of 12 months prior to screening,
- •inflammatory bowel, inflammatory bowel disease with small bowel involvement, short bowel syndrome, or other malabsorption syndrome) with known or suspected history of HOx (e.g., history of calcium oxalate kidney stones or oxalate nephropathy)
- •4.Has UOx excretion >= 50 mg/24 hr on an adequate (i.e., appropriate creatinine [mg/kg body weight] for sex) 24-hour urine collection at Screening
- •5.Has at least 1 documented kidney stone (spontaneous kidney stone
- •passage or intervention to remove kidney stone, or new or enlarged
- •stone on imaging) within 2 years prior to Screening (See Exclusion
- •Criterion 6)
- •6.Has provided 2 adequate 24-hour urine collections at Baseline, with average UOx excretion >= 50 mg/24 hr (and neither is < 40 mg/24 hr)
- •7.For subjects taking concomitant medication for management of kidney stone risk factors (e.g., thiazides, calcium supplements, alkali therapy, allopurinol): has been on a stable dose regimen for > 8 weeks prior to Screening, and with no changes in dosing (dose level or dosing frequency) anticipated during the first 24 weeks of the study Treatment Period
- •8.For female subjects: Is either medically incapable of pregnancy (e.g.,
- •has undergone hysterectomy or tubal ligation), is otherwise permanently
- •sterile, or is postmenopausal (defined as minimum 12 consecutive
- •months of amenorrhea not due to an alternative medical cause) or if a
- •woman is of childbearing potential, has a negative Screening serum
- •pregnancy test, is not pregnant or nursing at Screening, and agrees to
- •use a highly effective method of birth control for as defined in the
- •protocol for the duration of the study inclusive of the 1 month follow-up
- •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 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1.Has > 30% variability in the ratio of creatinine (mg)/body weight (kg) among the 3 24-hour urine collections prior to randomization (1 at screening - 2 at baseline)
- •2.Has eGFR< 30 mL/minute/1.73 m2 at Screening
- •3.Cannot establish Baseline kidney stone burden per study image acquisition requirements
- •4.Has a known genetic, congenital, or other cause of kidney stones (e.g., primary hyperoxaluria, cystinuria, primary hyperparathyroidism, medullary sponge kidney), or recent kidney stone (to satisfy Inclusion Criterion 5) was determined to be due to:
- •- infection (e.g., struvite stone, recurrent urinary tract infections)
- •- medications associated with crystalluria (e.g., carbonic anhydrase inhibitors [acetazolamide, topiramate], triamterene, protease inhibitors, guaifenesin, ephedrine, sulfonamides)
- •- medications known to cause fat malabsorption (e.g. orlistat)
- •5.Exclusions due to ongoing medication use at screening:
- •- Supplemental vitamin C (> 200 mg daily, including multivitamins)
- •- Chronic use of long-acting narcotic medication(s), or shortacting/immediate release narcotics at aggregate doses > 50 Morphine Milligram Equivalents (MME)/day
- •- Chronic therapy with high doses of systemic steroids use (i.e., > 10 mg/day prednisone or equivalent daily) or intensification of existing immunosuppressant or immunomodulatory therapy for treatment of acute disease flare within 4 weeks prior to Screening or during Screening
- •Note: Stable subjects on low chronic dose of steroids or maintenance
- •regimens of other immunosuppressant/immunomodulatory drugs, such
- •as transplant recipients, are not excluded
- •6.Any clinically significant finding during Screening (e.g., abnormality on Baseline imaging requiring assessment or intervention, acutely decreased kidney function, or other significant laboratory abnormalities), any ongoing clinically significant illness requiring an intervention or change in management within 4 weeks prior to Screening
- •(e.g., flare of inflammatory bowel disease), or any planned surgical/invasive procedure during the first 24 weeks of the study
- •Note: Subjects may be rescreened following resolution of the condition that led them to satisfy this exclusion criterion
- •7.Malignancy or treatment for malignancy within 12 months prior to Screening with the exception of localized basal cell or squamous cell skin cancer
- •Note: Subjects whose malignancy is in remission and who are on a stable dose of chronic suppressive or maintenance therapy are not excluded
- •8.Has received reloxaliase in any other clinical study, or participation in
- •another drug or device clinical trial within 30 days prior to or during
- •9.Is not, per Investigator judgment, an ideal clinical trial candidate due
- •to a personal issue or medical condition that is likely to impede
- •successful study completion.
研究者
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