ACTRN12618000910202已完成2 期
A Phase 2a, Double-blind, Randomised, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS) who are receiving Irbesartan
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Dimerix Ltd
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Aged 18 to 80 (inclusive) at screening;
- •2. A diagnosis of primary FSGS confirmed by renal biopsy;
- •3. Must be receiving a stable dose of 300 mg daily of irbesartan (in any marketed
- •formulation) for at least 3 months prior to screening, and have no plan to
- •change treatment regime throughout the study;
- •4. Patients can be on stable doses of angiotensin converting enzyme inhibitors,
- •aldosterone inhibitors, direct renin inhibitor and/or sodium-glucose cotransporter-2 inhibitors. However, the dose and regimen must be stable for 3 months prior to screening and must have no plan to change treatment regime throughout the study;
- •5. If taking immunosuppressive medications (except for rituximab or
- •cyclophosphamide), must have a stable treatment regime for 3 months prior to
- •screening and do not have plans to alter the regimen except to maintain
- •therapeutic immunosuppression or in the event of AEs. Patients who have
- •received rituximab or cyclophosphamide must have ceased treatment for at
- •least 6 months prior to screening;
- •6. Mean of two PCR values (screening and baseline) of equal to or greater than 150 mg/mmol
- •(1326 mg/g), and within plus or minus 30% of the screening value at the baseline
- •assessment;
- •7. Estimated GFR equal to or greater than 25 mL/min/1.73 m2 using chronic kidney disease
- •epidemiology collaboration (CKD-EPI) formula at screening;
- •8. Serum potassium levels (screening and baseline) less than 5.5 mmol/L. If either value is 5.5 or above, the patient may receive dietary advice and be retested 1 week later;
- •9. A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •Not of childbearing potential, defined as surgically sterile (documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or postmenopausal (no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone [FSH] level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single
- •FSH measurement is insufficient.);
- •Of childbearing potential and agrees to use a highly effective method of contraception consistently during the treatment period and for at least 60 days after the last dose of investigational product;
- •10. A male patient with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period and for at least 60 days after the last dose of investigational product and refrains from donating sperm during this period;
- •11. Have given written informed consent prior to any study procedures being performed.
排除标准
- •1. Has FSGS secondary to another condition;
- •2. A history of type 1 diabetes mellitus, diagnosis of type 2 diabetes mellitus prior to FSGS positive renal biopsy, or non-fasting blood glucose greater than 10 mmol/L at screening;
- •3. A prior organ or stem cell transplant;
- •4. A major adverse cardiac event within 6 months before screening;
- •5. Lymphoma, leukaemia, or any malignancy within the past 5 years except for basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ that have been resected with no evidence of metastatic disease for 3 years;
- •6. Jaundice, active hepatitis, or known hepatobiliary disease (except asymptomatic cholelithiasis);
- •7. Alanine aminotransferase and/or aspartate aminotransferase greater than 2 times the upper limit of normal at screening;
- •8. Participation in any clinical study with an experimental medication or device within 90 days or 5 half-lives (whichever is longer) of screening or have previously participated in a study involving propagermanium;
- •9. Positive screening assessment for viral hepatitis B surface antigen or hepatitis C virus (HCV) antibody AND positive HCV RNA or human immunodeficiency virus (HIV), or a history of illicit drug injecting;
- •10. Seated blood pressure of equal to or greater than 160/100 mmHg at screening;
- •11. Body mass index equal to or greater than 35 kg/m2 at screening;
- •12. Past hospitalisation for a major depressive episode;
- •13. Is breast feeding or pregnant;
- •14. Unable to comply with the study procedures and assessments, including the ability to swallow capsules;
- •15. Any other disease, physical or psychological condition that the investigator or sponsor believes may contraindicate the use of the investigational medicinal product or affect the interpretation of study results or render the patient at high risk from treatment complications;
- •16. Are investigator site personnel directly affiliated with this study or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
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