EUCTR2021-006579-41-LT进行中（未招募）1 期
A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-controlled Study of Safety and Efficacy Of ANG-3070 in Patients with Primary Glomerular Disease and Persistent Proteinuria
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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 participants aged 18 and older.
- •2. Diagnosis of IgA nephropathy or primary FSGS confirmed by renal biopsy at any time in the past, except for patients with type II diabetes who must have had a renal biopsy within prior 5 years showing no evidence of diabetic kidney disease. Participants with genetic forms of FSGS may be enrolled without a renal biopsy if the clinical picture is consistent with the genetic testing results and they are on the standard of care therapy for at least 12 weeks prior to enrollment in the study.
- •3. Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) = 30 mL/min/1.73m2.
- •4. Urinary protein excretion, as measured by UPCR (geometric mean of 3 first-void urine), per threshold values below:
- •a) IgA nephropathy: = 750 mg/g or 85 mg/mmol of creatinine
- •b) FSGS = 1000 mg/g or 113 mg/mmol of creatinine
- •5. Stable blood pressure = 140/90 mmHg with stable antihypertensive regimen for at least 12
- •weeks prior to screening.
- •6. All participants must be on the SOC therapy including the maximally tolerated/recommended doses of an Angiotensin-converting enzyme inhibitor (ACEi) or ARB, but not both.
- •7. Renin-angiotensin-aldosterone system (RAAS) blockers and Sodium glucose co-transporter 2 (SGLT-2) inhibitors must be stable (optimized, established dose) for at least 12 weeks prior to screening and projected to remain stable through week 16 (dose adjustment allowed if clinically indicated).
- •8. Immunosuppressive or immunomodulatory therapy must be stable (optimized, established
- •dose) for at least 12 weeks prior to screening and projected to remain stable through study week 16 (dose adjustment allowed if clinically indicated).
- •9. Both genders of childbearing potential must agree to use adequate contraception, during and for at least 3 months after the last dose of study drug.
- •10. Participants must be willing and able to give written Informed Consent and to comply with
- •protocol requirements.
- •11. Participants must be judged to be otherwise fit for the study by the Investigator.
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Laboratory and Assessments
- •1. Positive Hepatitis B (HBV), Hepatitis C (HCV), or human immunodeficiency virus (HIV) viral screening test; historical or during the screening.
- •2. Hematologic abnormalities as follows: Hemoglobin (Hb) <8 g/dL, or platelets <50,000, or absolute neutrophil count (ANC) <1000 cells/µL at baseline.
- •3. Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) or total bilirubin > 2 ULN.
- •4. Hemoglobin A1C > 8.5% (only for patients with history of diabetes).
- •Excluded Medications
- •5. Participants taking non-steroidal anti-inflammatory agents (NSAIDS) chronically (intermittent, i.e., occasional NSAIDS for pain or fever is discouraged, but is not excluded). No NSAIDS allowed within 72 hours of the scheduled lab work to determine eGFR and/or urinary protein and creatinine measurements.
- •6. Participants taking strong inducers (e.g., phenytoin, rifampin) or inhibitors (e.g., clarithromycin, itraconazole) of CYP3A4. Please see Appendix 1.
- •Bleeding or Thrombosis Risk
- •7. Known predisposition to bleeding.
- •8. Participants who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin etc.), or high dose antiplatelet therapy. Prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/d, or clopidogrel at 75 mg/d, or equivalent doses of other antiplatelet therapy) is not excluded.
- •9. History of hemorrhagic central nervous system (CNS) event within 12 months of the screening
- •10. History of active gastrointestinal bleeding within 6 months of the Screening visit.
- •11. History of thrombotic event (including stroke and transient ischemic attacks) within 12 months
- •of the Screening visit.
- •Other excluding conditions and medical judgement
- •12. Type I diabetes mellitus.
- •13. Histopathological evidence of diabetic kidney disease on the renal biopsy.
- •14. Membranous nephropathy.
- •15. Myocardial infarction or unstable angina within 6 months of the screening visit.
- •16. History of solid organ or hematopoietic cell transplantation.
- •17. On an organ transplant waiting list or anticipated organ transplant within 6 months of screening.
- •18. History of treated Hepatitis C (HCV).
- •19. Participation in any clinical study of an investigational product within 12 weeks from the date
- •of screening.
- •20. History or presence of any form of cancer within 2 years of screening except excised basal or squamous cell carcinoma of the skin.
- •21. Renal disease secondary to systemic disease including but not limited to: systemic lupus erythematosus, anti-neutrophil cytoplasmic antibodies -associated diseases, anti-glomerular basement disease, secondary forms of focal segmental glomerulosclerosis, renal diseases associated with para-proteinemias, C3 glomerulopathy, and diabetic kidney disease.
- •22. Treatment with Anti-CD20 monoclonal antibodies within 6 months prior to screening.
- •23. A known systemic disorder that requires, or is expected to require, systemic glucocorticoids or immune modulators during the study.
- •24. BMI =40 Kg/m2
- •25. Pregnant women or women who are breast feeding or of child-bearing potential not willing to use two effective methods of birth control (1 barrier and 1 highly effective non-barrier) during the study from screening until 3 months after end of treatment.
- •26. Sexually active males not committing to using condoms during the study (except if their partner is not of childbearing potential) and 3 months after end of treatment.
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