EUCTR2019-002531-29-GB进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A (IgA) Nephropathy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
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. Participant is a male or female = 18 years of age at the time of signing the informed consent.
- •2. Participant has biopsy-confirmed IgAN.
- •3. Participant has medical records showing they have been on stable and maximally tolerated doses of either ACEI or ARB, as per SOC and applicable guidelines, for at least 3 months preceding screening. Participants should be on at least 50% of the maximum recommended dose of these agents to be considered as having adequate RAAS blockade.
- •Participants who are unable to tolerate ACEI/ARB therapy may be eligible for participation in the study if their overall management of IgAN, including BP control, is as per SOC and applicable guidelines.
- •4. Participant has screening uPCR = 0.75 g/g measured from a 24-hour urine (or an intended 24-hour urine sample) or 24-hour urine protein = 1.0 g/d, as measured from 24-hour urine collection (or an intended 24-hour urine sample). The proteinuria should be stable, defined as < 25% change when compared to values from = 3 months previously (if
- •available).
- •If previous values are not available or if the change from a prior value is > 25%, a repeat measurement of proteinuria will be done after 15 days and the participant should fulfill the above proteinuria criteria to be eligible for randomization in the study.
- •The proteinuria should be assessed when the participant is considered to be in a steady state with no recent heavy exercise, fever, or other potential issues that could impact the result.
- •5. Participant has eGFR = 45 mL/min/1.73 m2, calculated using the CKD-EPI formula. The eGFR should be stable, as defined by a < 25% change when compared to values from = 3 months previously (if available).
- •If previous values are not available or if the change from a prior value is > 25%, a repeat measurement of eGFR will be done after 15 days and the participant should fulfill the eGFR criteria to be eligible for randomization in the study.
- •The eGFR should be measured when the participant is considered to be in a steady state without recent changes in volume status, medications that could impact the result (eg, nonsteroidal anti-inflammatory drugs [NSAIDs], aminoglycosides, co-trimoxazole), or changes in dietary protein intake.
- •6. Participant’s serum Ig values must meet the following criteria :
- •IgG: = 700 mg/dL
- •IgM: = 40 mg/dL
- •IgA: = 70 mg/dL
- •7. Female participants of childbearing potential must have a negative serum pregnancy test prior to the first dose.
- •8. Participant is willing to adhere to contraceptive requirements outlined in Appendix 4.
- •9. Participant or a legally authorized representative is able to understand the purpose and risks of the study and is willing to give voluntary written informed consent as described in Appendix 1.
- •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 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •1. Participant has secondary forms of IgAN as defined by the treating physician (eg, Henoch-Schonlein purpura, minimal change disease with IgA deposits, infection associated IgAN, or IgAN-associated with hepatic cirrhosis).
- •2. Participant has co-existing CKD, other than IgAN.
- •3. Participant has evidence of additional pathological findings in the kidney biopsy (eg, diabetic kidney disease, membranous nephropathy, or lupus nephritis). However, hypertensive vascular changes are acceptable.
- •4. Participant has kidney biopsy MEST or MEST-C score of T2 or C2 from the Oxford IgAN classification schema. If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis or crescents in > 25% of glomeruli is exclusionary.
- •5. Participant has nephrotic syndrome, defined for this purpose as 24-hour urine protein > 3.5 g with concurrent hypoalbuminemia (serum albumin < 2.5 g/dL), hyperlipidemia (total cholesterol > 350 mg/dL), and edema.
- •6. Participant has received a solid organ transplant, including kidney.
- •7. Participant has received bone marrow or hematologic stem cell transplantation.
- •8. Participant is currently receiving systemic immunosuppression (excluding topical, ophthalmic, per rectum, or inhaled corticosteroids).
- •9. Participant has received systemic steroids within the 24 weeks prior to initial screening.
- •10. Participant has received treatment with 2 or more systemic immunosuppressive agents within 2 years prior to initial screening.
- •11. Participant has chronic infectious diseases (eg, chronic urinary tract infection; chronic sinusitis; bronchiectasis; active pulmonary or systemic tuberculosis; chronic viral hepatitis, such as hepatitis C or hepatitis B; or human immunodeficiency virus infection).
- •12. Participant has acute infectious disease at the time of screening. Participants may be rescreened following resolution of acute infection (such as urinary tract infection or respiratory tract infection), provided there is no evidence of an immunosuppressive condition that predisposed the participant to this infection.
- •13. Participant has Type 1 diabetes.
- •14. Participant has uncontrolled Type 2 diabetes, as evidenced by a screening hemoglobin A1c value > 8%.
- •15. Participant has uncontrolled BP (> 140 mm Hg systolic or > 90 mm Hg diastolic), Systolic and diastolic BP should be assessed while the participant is seated or supine for at least 5 minutes in a quiet room without distractions. BP should be measured with a completely automated device. At least 3 readings should be taken and average values from these 3 readings should be calculated.
- •16. Participant has a history of chronic autoimmune neurodegenerative disorder such as multiple sclerosis.
- •17. Participant has a known allergy or intolerance to any component of the study intervention.
- •18. Participant has poorly compensated or controlled ischemic heart disease or cardiomyopathy, as judged by the Investigator.
- •19. Participant has chronic obstructive pulmonary disease (COPD) or asthma that has required systemic steroid therapy during the prior year. If COPD is present, severity must not exceed Global Initiative for Chronic Obstructive Lung Disease 1 (mild), defined as a forced 1-second expiratory volume (FEV1) > 80% of predicted.
- •20. Participant has known cirrhosis or liver dysfunction, defined as presence of coagulopathy, platelet count < 100,000/µL or alanine aminotransferase > 3× upper limit of normal.
- •21. Partic
研究者
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