EUCTR2020-005054-19-BG进行中（未招募）1 期
A Double Blind, Randomized, Placebo-Controlled, Multicenter Phase IIa, Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab in IgA Nephropathy - IGNAZ
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
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. Patients = 18 to = 80 years (at date of signing the informed consent form [ICF]), but at least
- •of legal age in the given country
- •2. Biopsy confirmed diagnosis of IgAN within the past 8 years prior to signature of the ICF
- •3. Proteinuria at screening visit = 1.0 g/d
- •4. Treatment with an angiotensin-converting enzyme inhibitor (ACEi) and/or angiotensin receptor blocker (ARB) at maximum doses or maximally tolerated doses for = 3 months prior to date of informed consent and adequate blood pressure (BP) control (recommended BP is < 125 mm Hg systolic and < 75 mm Hg diastolic).
- •In case a patient is intolerant to even a very low dose of either ACEi or ARB therapy, approval for participation in the trial has to be obtained from the Medical Monitor prior to randomization.
- •5. A female of childbearing potential (FCBP) is only eligible to participate if she is not pregnant, not breast feeding, and agrees to follow the contraceptive guidance 5 during the treatment period and for at least 3 months after the last dose of Felzartamab.
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •1. Secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits (e.g. Lupus nephritis, Schönlein-Henoch purpura, ankylosing spondylitis, dermatitis herpetiformis, chronic liver disease, inflammatory bowel disease, celiac disease).
- •2. Severe renal impairment as defined by estimated GFR < 30 mL/min (using chronic kidney
- •disease-epidemiology collaboration [CKD-EPI] formula) or the need for dialysis or renal transplant.
- •3. Rapidly progressive variant of IgAN, defined as eGFR loss by more than 30% per 3 months and not explained by changes in renin angiotensin system (RAS) blockade.
- •4. Minimal change variant of IgAN.
- •5. Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.
- •6. Systemic immunosuppression (e.g. mycophenolate mofetil [MMF], cyclophosphamide, biologics like rituximab [RTX]), in particular corticosteroid therapy exceeding 20 mg/day prednisone-equivalent for more than 7 consecutive days within 180 days prior to signing ICF.
- •7. Any previous treatment with an anti-CD38 antibody.
- •8. Body mass index (BMI) > 35 kg/m^2.
- •9. Hemoglobin < 90 g/L.
- •10. Thrombocytopenia: Platelets < 100.0 x 10^9/L.
- •11. Neutropenia: Neutrophils < 1.5 x 10^9/L.
- •12. Leukopenia: Leukocytes < 3.0 x 10^9/L.
- •13. Diabetes mellitus type 1.
- •14. Diabetes mellitus type 2: Patients with type 2 diabetes mellitus may only enter the clinical trial if a kidney biopsy performed within 6 months prior to signing ICF shows IgAN without evidence of diabetic nephropathy and their disease is controlled, such as:
- •a. Glycated hemoglobin (HbA1c) < 8.0% or < 64 mmoL/mol.
- •b. No diabetic retinopathy known.
- •c. No peripheral neuropathy known.
- •15. Significant uncontrolled cardiovascular disease (including arterial or venous thrombotic or embolic events) or cardiac insufficiency (New York Heart Association [NYHA] class IV) as judged by the investigator.
- •16. Clinically significant findings on a 12-lead electrocardiogram (ECG) as determined by the investigator at screening.
- •17. History of significant cerebrovascular disease or sensory or motor neuropathy of toxicity = grade 3.
- •18. Aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN.
- •19. Known or suspected hypersensitivity to Felzartamab and its excipients (L-histidine, sucrose, polysorbate 20).
- •20. Serologic markers positive for HIV or history of HIV, hepatitis C (patients with positive anti-hepatitis C virus [anti-HCV] antibody but negative HCV RNA polymerase chain reaction [PCR] can enroll) or active or latent hepatitis B (patients with positive hepatitis B surface antigen [HBsAg] are excluded). For patients with positive hepatitis B core antibody [anti-HBc], hepatitis B virus (HBV) DNA test by PCR must be non-detectable to enroll).
- •21. Any malignancy within 5 years prior to screening start, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or other non-melanomatous skin cancer.
- •22. Treatment within 5 terminal half-lives (if known) or within the last 30 days prior to Visit 2, whatever is longer) with investigational drugs.
- •23. Any active infection (viral, fungal, bacterial) requiring systemic therapy.
研究者
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