EUCTR2018-002716-27-GB进行中（未招募）1 期
A Phase 2, Randomized, Double-blind, Placebo-controlled Study of Cemdisiran in Adult Patients with IgA Nephropathy - A Phase 2 Study of Cemdisiran in Adult Patients with IgA Nephropathy
Alnylam Pharmaceuticals Inc0 个研究点目标入组 30 人开始时间: 2019年1月7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
- 30
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 =18 years and =65 years of age at the time of informed consent
- •2. Clinical diagnosis of primary IgAN as demonstrated by historical biopsy collected within 60 months of Screening
- •3. Treated for IgAN with stable, optimal pharmacological therapy. In general, stable and optimal treatment will include maximum allowed or tolerated ACE inhibitor or an ARB for at least 3 months prior to start of run-in period
- •4. Urine protein =1 g/24-hour at Screening from a valid 24-hour urine collection (see Section 6.4.1.1), and mean urine protein =1 g/24-hour from two valid 24-hour urine collections at the end of the run-in period, prior to randomization
- •5. Hematuria as defined by =10 RBCs per high powered field (RBC/hpf) by microscopy or a positive urine dipstick (2+ [moderate] and above) measured by a central laboratory at Screening
- •6. Females of child-bearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use a highly effective method of contraception 14 days before first dose, throughout study participation, and for 90 days after last dose administration
- •7. Previously vaccinated with meningococcal group ACWY conjugate vaccine and meningococcal group B vaccine or willingness to receive these vaccinations as well as prophylactic antibiotic treatment if required by local standard of care
- •8. Previously vaccinated or willingness to receive vaccinations for Hib and Streptococcus pneumoniae according to current national/local vaccination guidelines for vaccination use
- •9. Patient is willing and able to provide written informed consent and to comply with the study requirements
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Concomitant significant renal disease other than IgAN
- •2. A diagnosis of rapidly progressive glomerulonephritis as measured by eGFR loss >30% over the duration of the run-in phase
- •3. Secondary etiologies of IgAN (eg, inflammatory bowel disease, celiac disease)
- •4. Diagnosis of Henoch-Schonlein Purpura (IgA Vasculitis)
- •5. eGFR <30 mL/min/1.73 m2 2 weeks prior to randomization (local results may be used for assessment of eligibility)
- •6. Has any of the following laboratory parameter assessments:
- •a. Alanine transaminase (ALT) >1.5×upper limit of normal (ULN), International Normalized Ratio (INR) >2 (or >3.5 if on anticoagulants), or total bilirubin >1.5×ULN (unless bilirubin elevation is due to Gilbert’s syndrome)
- •7. Confirmed positive IgG/IgM/IgA ADAs to cemdisiran at Screening
- •8. Clinical laboratory test results considered clinically relevant and unacceptable in the opinion of the Investigator
- •9. Positive hepatitis B virus (HBV) surface antigen, HBV core antibody, hepatitis C virus (HCV) antibody (unless HCV viral load demonstrated negative)
- •10. Treatment with systemic steroids for more than 7 days or other immunosuppressant agents in the 6 months prior to randomization
- •11.Treatment with dual RAS blockade in the 3 months prior to entry into the run-in phase
- •12. 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
- •13.Known human immunodeficiency virus (HIV) infection, HCV infection or HBV infection
- •14. Malignancy (except for non-melanoma skin cancers, cervical in situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate cancer) within the last 5 years
- •15. Active psychiatric disorder, including, but not limited to schizophrenia, bipolar disorder, or severe depression despite current pharmacological intervention
- •16. Known medical history or evidence of chronic liver disease or cirrhosis
- •17. Has other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation
- •18. History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc
- •19. History of intolerance to SC injection(s) or significant abdominal scarring that could potentially hinder study drug administration or evaluation of local tolerability
- •20. Known contraindication to meningococcal vaccines (group ACWY conjugate and group B vaccines) required for this study. Refer to the most recent local product information for each vaccine for the current list of contraindications
- •21. Unable to take antibiotics for meninigococcal prophylaxis, if required by local standard of care
- •22. Sustained blood pressure >140/90 mmHg as defined by 2 or more readings during the run-in period, measured in supine position after 10 minutes of rest
- •23. Receipt of an organ transplant (including hematologic transplant)
- •24. History of meningococcal infection within 12 months before Screening
- •25. Patients with systemic bacterial or fungal infections, that require systemic treatment with antibiotics or antifungals
- •26. Patients with functional or anatomic asplenia
- •27. Patients who consume more than 14 units of alcohol a week (unit 1 glass of wine [125 mL] = 1 measure of spirits [approximately 1 fluid ounce] = ½ pint of beer [approximately 284 mL])
研究者
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