NL-OMON50604已完成2 期
Multicenter, Randomized, Double-blind, Placebo-controlled Two Stage Study to Characterize the Efficacy, Safety, Tolerability and Pharmacokinetics of GZ/SAR402671 in Patients at risk of Rapidly Progressive Autosomal Dominant Polycystic Kidney Disease (ADPKD) - STAGED-PKD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male or female adult with ADPKD:
- •a) between ages of 18 and 50 years (inclusive) for patients in Stage 1
- •b) between 18 and 50 years (inclusive) for patients in Stage 2 with an eGFR
- •between 45 and 89.9 mL/min/1.73 m2 during the screening period
- •c) between 18 and 55 years (inclusive) for patients in Stage 2 with an eGFR
- •between 30 and 44.9 mL/min/1.73 m2 during the screening period
- •Diagnosis of ADPKD in patients with a family history, will be based on unified
- •Pei criteria. In the absence of a family history, the diagnosis will be based
- •on the presence of renal cysts bilaterally, totaling at least 20, in the
- •absence of findings suggestive of other cystic renal diseases.
- •- Mayo Imaging Classification of ADPKD Class 1C, 1D or 1E.
- •- Estimated glomerular filtration rate between 45 to 89,9 mL/min/1.73 m2 during
- •the screening period (Chronic Kidney Disease Epidemiology Collaboration
- •[CKD-EPI]) for stage 1.
- •- Estimated glomerular filtration rate between 30 and 89.9 mL/min/1.73 m2
- •screening period (CKD-EPI equation) for Stage 2.
- •- Stable treatment regimen of antihypertensive therapy for at least 30 days
- •prior to the screening visit for hypertensive patient.
- •- Able to read, comprehend, and respond to the study questionnaires.
- •- Patient has given voluntary written informed consent before performance of
- •any study related procedures not part of standard medical care.
- •- Patient does not have access to tolvaptan at the time of study start or
- •tolvaptan is not indicated for treatment of patient according to treating
- •physician (patient does not meet recommended criteria for treatment or does not
- •tolerate treatment with tolvaptan).
- •- The patient, if female of childbearing potential, must have a negative blood
- •pregnancy test (*-human chorionic gonadotropin [*-hCG]) at the screening visit
- •and a negative urine pregnancy test at the baseline visit.
- •- Female patients of childbearing potential and male patients must agree to
- •practice true abstinence in line with their preferred and usual lifestyle or to
- •use double-contraceptive methods (including a highly effective method of
- •contraception for female participants of childbearing potential) for the entire
- •duration of the study and for at least 6 weeks for females and 90 days for
- •males following their last dose of study drug
排除标准
- •- Systolic BP >160 mmHg at run-in and baseline visits.
- •- History of administration of tolvaptan or other Polycystic Kidney
- •Disease-modifying agents (somatostatin analogues) within 3 months prior to the
- •screening visit.
- •- The patient, in the opinion of the Investigator, is unable to adhere to the
- •requirements of the study or unable to undergo study assessments (eg, has
- •contraindications to pupillary dilation or unable to undergo magnetic resonance
- •imaging [MRI] [For example: patient*s weight exceeds weight capacity of the
- •MRI, ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia,
- •large abdominal/back tattoos, etc]).
- •- Current participation in another investigational interventional study or use
- •of investigational medicinal product (IMP), within 3 months or 5 half-lives,
- •whichever is longer, before randomization.
- •- The patient has a positive result of any of the following tests: hepatitis B
- •surface antigen [HBsAg], anti-hepatitis C virus [anti-HCV] antibodies,
- •anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti-HIV2
- •Ab). Patients with a positive hepatitis B surface antibody (HBsAb) test are
- •eligible if other criteria are met (ie, negative tests for: HBsAg, hepatitis B
- •core antibody [HBcAb], and hepatitis C virus antibody [HCVAb]). Patients immune
- •due to natural infection (positive HBsAb, negative HBsAg, positive HBcAb) are
- •eligible if they have a negative HBV DNA test.
- •- A history of drug and/or alcohol abuse within the past year prior to the
- •screening visit.
- •- A history of alcohol dependence within the 5 years prior to the screening
- •- Any patient who is the Investigator or any Subinvestigator, research
- •assistant, pharmacist, study coordinator, other staff, or relative thereof
- •directly involved in the conduct of the study.
- •- The patient is scheduled for in-patient hospitalization including elective
- •surgery, during the
- •- The patient has a clinically significant, uncontrolled medical condition
- •that, in the opinion of the investigator, would put the safety of the subject
- •at risk through participation, or which would affect the efficacy or safety
- •analysis if the condition exacerbated during the study, or that may
- •significantly interfere with study compliance, including all prescribed
- •evaluations and follow-up activities.
- •The list of medical conditions that should be taken into account includes, but
- •is not limited
- •to the following:
- •Congestive heart failure New York Heart Association (NYHA) Grade III/IV),
- •clinically significant cardiac arrhythmia, severe unstable angina pectoris
- •within 6 months of Visit 1, hypertensive
- •emergency within 6 months of Visit 1, stroke or transient ischemic attack
- •within 3 months of Visit 1, myocardial infarction within 3 months of Visit 1,
- •current malignancy, tuberculosis (current or untreated), Cushing's disease,
- •Addison's disease, uncontrolled diabetes mellitus, uncontrolled thyroid disorder
- •- Any country-related specific regulation that would prevent the patient from
- •entering the
- •- The patients did not adhere to treatment (<70% compliance rate) in the run-in.
- •- The patient has, according to World Health Organization (WHO) Grading (13), a
- •cortical cataract *1-quarter of the lens circumference (Grade cortical
- 另有 1 项未显示
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