CTRI/2023/06/053691招募中3 期
A Phase 3 Superiority Study Comparing the Safety and Efficacy of SNP-ACTH (1-39) Gel compared to Rituximab and FDA approved biosimilars in Adults with Primary Membranous Nephropathy (PMN) in a Two-Phase Adaptive Trial Design.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •To be eligible for the study, an individual must meet all the following criteria:
- •1. = 18 years old
- •2. Biopsy-proven membranous glomerulonephritis or a diagnosis of MN and a positive anti PLA2R antibody test.
- •3. Patients classified to be at a High Risk for progressive loss of kidney function, as defined by KDIGO 2021-Glomerular Diseases Guideline
- •a. eGFR of <60 mL/min/1.73 m2 and/or proteinuria >8 g/d for >6 months or
- •b. Normal eGFR, proteinuria >3.5 g/d and no decrease >50% after 6 months of conservative therapy with ACEi / ARB and at least one of the following: PLA2R antibody levels >50 RU/ml, serum albumin <25 g/L, urinary a1-microglobin >40 µg/min, urinary ß2-microglobin > 250 mg/d
- •c. Patient meeting above criteria as per PI discretion as High Risk Patient.
- •4. eGFR by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula =40 mL/min/1.73 m2
- •5. Stable dose of blood pressure (BP) medication for at least 1 month
- •6. Prophylactic anticoagulation should be employed in patients when the risk of thromboembolism exceeds the estimated patient-specific risks of an anticoagulation
- •7. Life expectancy > 24 months
- •8. Vaccinated for coronavirus disease 2019 (Covid-19) before randomization.
- •9. Vision sufficient to measure a syringe volume or a caretaker who can do the same.
- •10. Patients who have had CR (Complete Remission) or PR (Partial Remission) in response to immunosuppressive therapy, however if relapsed can participate in the study if they have received high dose glucocorticoids, calcineurin inhibitors, mycophenolate Mofetil (MMF) for more than 3 months since their last dose.
- •11. Patients who have had CR or PR in response to immunosuppressive therapy, however if relapsed can participate in the study if they have received chlorambucil or CYC (cyclophosphamide) more than 6 months since their last dose.
- •12. Patients who have had CR or PR in response to immunosuppressive therapy, but then relapsed can participate in the study if it has been more than 12 months since their last dose of Rituximab.
- •13. If all Inclusion Points are met but patient has not been on a stable dose of ACEi (angiotensin-converting enzyme inhibitor ) or ARB (angiotensin receptor blocker ) for 90 days, he/she will be asked to return for screening once the dose of ACEi or ARB has not changed in 90 days.
排除标准
- •An individual who meets any of the following criteria will not be enrolled in the study:
- •1. Secondary membranous nephropathy as defined by history, physical exam, kidney biopsy results or serologies.
- •2. A confirmed diagnosis of diabetes.
- •3. Patient with fasting blood glucose >126 mg/dL hemoglobin A1C will be tested, If the A1C level is > 6.5% and the patient will be excluded
- •4. Renal biopsy showing glomerular disease other than MN or clinical manifestations, history, serology, or biopsy findings
- •5. Patients who have had a 50% or greater decrease in their baseline proteinuria levels within the last year in the absence of IS or cytotoxic therapy
- •6. Patients who have had a = 50% reduction in serum titers of PLA2R (phospholipase A2 receptor) auto-antibody within 1 year before screening.
- •7. Patients who were non responders to previous IS treatments
- •8. Patients who must be initiated on drugs likely to affect renal function
- •9. Blood serologies suggestive of lupus nephritis or glomerular diseases other than PMN.
- •10. Pregnancy as determined by serum quantitative human chorionic gonadotropin (hCG) level.
- •11. Active infectious disease either clinically or, serologically, or culture based.
- •12. Patients with active hepatitis.
- •13. Past clinical history of Hepatitis B without anti-HBs antibodies.
- •14. Chronic Hepatitis C (HCV) with no successful virologic curative therapy.
- •15. Inability to give informed consent in the absence of a legal surrogate
- •16. History of cancer in remission for < 3 years excluding basal cell skin cancer and squamous cell skin cancer under surveillance by a dermatologist.
- •17. Scleroderma
- •18. Osteoporosis
- •19. Latent tuberculosis or tuberculin positivity as shown by the QuantiFERON Gold test.
- •20. Ocular herpes simplex present or history thereof.
- •21. Surgery within 1 month of study entry.
- •22. Uncompensated congestive heart failure
- •23. History of sensitivity to proteins of porcine origin.
- •24. Myasthenia gravis
- •25. Untreated hypothyroidism
- •26. Clinical liver disease diagnosed by a health care provider by signs and symptoms or biochemical liver disease manifest
- •27. Hemoglobinopathies including sickle cell disease.
研究者
相似试验
进行中（未招募）
不适用
A Phase III Safety and Efficacy Study to Compare Immune Responses following Injection with Either Two Doses of HEPLISAV™ or Three Doses of Engerix-B®Prevention of Hepatitis B Virus (HBV) infection.MedDRA version: 9.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationEUCTR2006-006743-31-DEDynavax Technologies Corporation2,400
已完成
不适用
A PHASE III TRAIL TO COMPARE THE SAFETY AND EFFICACY OF LAPATINIB PLUS TRASTUZUMAB PLUS AN AROMATASE INHIBITOR (AI) VERSUS TRASTUZUMAB PLUS AN AI VERSUS LAPATINIB PLUS AN AI AS FIRST-LINE THERAPY IN POSTMENOPAUSAL SUBJECT WITH HORMONE RECEPTOR POSITIVE, HER2-POSITIVE METASTATIC BREAST CANCER (MBC) WHO HAVE RECEIVED TRASTUZUMAB AND ENDOCRINE THERAPY IN THE NEOADJUVANT AND/OR ADJUVANT SETTINGPER-126-11OVARTIS BIOSCIENSES PERU S.A.,5
进行中（未招募）
不适用
A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsCystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR MutationMedDRA version: 18.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2013-000604-41-IEVertex Pharmaceuticals Incorporated1,000
已完成
3 期
A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutatio10083624Cystic FibrosisNL-OMON41659Vertex Pharmaceuticals28
进行中（未招募）
1 期
A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsCystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR MutationMedDRA version: 16.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2013-000604-41-ITVertex Pharmaceuticals Incorporated1,000