EUCTR2017-000663-33-GB进行中（未招募）1 期
A Phase 2, Proof-of-Concept, Randomized, Double-Blinded, Placebo-Controlled Study of ACH-0144471 Treatment for 6 Months in Patients with C3 Glomerulopathy (C3G)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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. Must have confirmed primary C3G as per the following:
- •Initial diagnosis of C3G established at least 3 months prior to the first dose of study drug
- •Initial diagnosis prior to the age of 55
- •Not secondary to another underlying condition in the opinion of the PI
- •2. Confirmation of DDD or C3GN diagnosis by review of a renal biopsy obtained no more than 30 days (and preferably within 2 weeks) of first dose of study drug by the study’s central pathology laboratory
- •3. Must be between the ages of 17 and 65 years, inclusive
- •4. Clinical evidence of ongoing disease based on significant proteinuria (defined as =1 g/day of protein in a 24-hour urine) attributable to C3G disease in the opinion of the PI, and present prior to study entry and confirmed during Screening
- •5. If on corticosteroids, anti-hypertensive medications, anti-proteinuric medications (e.g., ACE inhibitors or angiotensin receptor blockers [ARBs]), or mycophenolate mofetil (MMF), must be on a stable dose for at least four weeks prior to the first screening visit
- •6. Female participants of childbearing potential must agree to use an acceptable method of contraception (as defined in Section 5.5.5) from the date of signing the informed consent to the first day of dosing (Day 1), and must agree to use a highly effective form of contraception (as defined in Section 5.5.5) from the first day of dosing to 30 days after their last dose of study drug. Female participants of childbearing potential must also have a negative serum pregnancy test during Screening and negative urine pregnancy test on Day 1. Female participants of non-childbearing potential need not employ a method of contraception
- •7. Non-sterile male participants must agree to use a highly effective form of contraception (as defined in Section 5.5.5) with their partner(s) of childbearing potential from the first day of dosing to 90 days after their last dose of study drug.
- •Males who are surgically sterile need not employ additional contraception.
- •Males must agree not to donate sperm while enrolled in this study and for 90 days after their last dose of study drug.
- •8. Must be capable of providing written informed consent, must be willing and able to comply with the requirements and restrictions listed in the consent form and with all procedures in the protocol, including, the visit schedule, the treatment plan, the schedule for laboratory testing, and other study procedures
- •9. Must be up-to-date on routine vaccinations, or willing to be brought up-to-date, based on local guidelines
- •10. Must be willing to comply with study-specific vaccination requirements, including those for N. meningitidis, H. influenzae, and S. pneumoniae
- •11. Must be willing, at all times for the duration of study participation, to have transportation and telephone access, and to be within one hour of an emergency medical center
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Have a history or presence of any clinically relevant co-morbidities
- •that would make the patient inappropriate for the study (for example, a
- •comorbidity which is likely to result in deterioration of the patient's
- •condition, affect the patient's safety during the study, or confound the
- •results of the study), in the opinion of the PI
- •2. Have ever received ACH-0144471
- •3. Have more than 50% fibrosis or more than 50% of glomeruli with
- •cellular crescents on the pre-treatment renal biopsy
- •4. Have an estimated GFR <30 mL/min/1.73 m^2 at the time of screening or at any time over the preceding four weeks
- •5. Have C4 levels <80% LLN at the time of screening
- •6. Is a renal transplant recipient or receiving renal replacement therapy
- •7. Have a history of a major organ transplant (e.g., heart, lung, kidney,
- •liver) or hematopoietic stem cell/marrow transplant
- •8. Have evidence of monoclonal gammopathy of unclear
- •significance(MGUS), infections, malignancy, autoimmune diseases, or other conditions to which C3G may be secondary
- •9. Have other renal diseases that would interfere with interpretation of
- •10. Have a comorbid condition that would pose a safety risk to the
- •patient, including participating in a renal biopsy, or interfere with
- •completion of the trial (e.g., active malignancy, uncontrolled congestive
- •heart failure within the previous 6 months, myocardial infarction within
- •the previous 12 months, other significant acute or chronic illness that is
- •not controlled, or requirement for continuous anticoagulant therapy)
- •11. Have been diagnosed with or show evidence of hepatobiliary
- •cholestasis
- •12. Are known to have Gilbert's syndrome and/or have a history
- •suggestive of Gilbert's syndrome
- •13. Females who are pregnant, nursing, or planning to become pregnant
- •during the study or within 90 days of study drug administration
- •14. Have a history of febrile illness, a body temperature >38°C, or other
- •evidence of a clinically significant active infection, within 14 days prior
- •to study drug administration
- •15. Have evidence of human immunodeficiency virus (HIV) (positive
- •serology for HIV antibody [HIV Ab]), hepatitis B infection (positive
- •hepatitis B surface antigen [HbsAg]), or hepatitis C infection (positive
- •anti-HCV antibody [HCV Ab]) at Screening or historically
- •16. Have a history of meningococcal infection, or a first-degree relative
- •or household contact with a history of meningococcal infection
- •17. Have a contraindication to one or more of the required vaccinations
- •18. Have a history of hypersensitivity reactions to commonly used
- •antibacterial agents, including beta-lactams, penicillin, aminopenicillins,
- •fluoroquinolones, cephalosporins, and carbapenems, which, in the
- •opinion of the investigator and/or an appropriately qualified
- •immunology or infectious disease expert, would make it difficult to
- •properly provide either empiric antibiotic therapy or treat an active
- •19. Have participated in a clinical study in which an investigational drug
- •was given within 30 days, or within 5 half-lives of the investigational
- •drug, whichever is longer, prior to the first dose of study drug
- •20. Have received eculizumab at any dose or interval within the past 75
- •days prior to the first dose of study drug
- •21. Have received tacrolimus or cyclosporine within 2 weeks of the first
- 另有 3 项未显示
研究者
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