BEL116472. A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy

GlaxoSmithKline Research and Development Ltd0 个研究点目标入组 14 人开始时间: 2012年4月2日最近更新: 2019年6月30日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 14

研究概览入排标准研究者记录与标识符相似试验

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

入选标准

•A subject will be eligible for inclusion in this study only if all of the
•following criteria apply:
•1. Age & Gender: Male or female between 18 and 75 years of age
•inclusive, at the time of signing the informed consent.
•2. Histological diagnosis: Have clinical diagnosis of IMGN, as verified by
•biopsy (either by light microscope with immuno-fluorescence, or by
•electron microscope) in the last 7 years with non-active disease >3
•years (non-active defined as subject not on immunosuppressants and proteinuria <2g per 24h) (biopsy results and
•slides should be available for independent evaluation).
•3. Autoantibody: Have positive anti-PLA2R autoantibody test results at screening.
•4. Proteinuria: Have clinically active disease (nephrotic range
•proteinuria) for at least 3 months prior to screening and no improvement (<30% reduction), despite supportive therapy (which should include maximal tolerated doses of ACE inhibitor or ARB unless contraindicated, and may include statins, diuretics, dietary salt restriction). During screening proteinuria must be >400mg/mmol by PCR (or >4.0g per 24 h) as measured from a 24 h urine collection and/or spot urine sample (early morning where possible) on 2 occasions at least 7 days apart.
•5. Female Subjects: A female subject is eligible to participate if she is not pregnant or nursing and at least one of the following conditions apply: a. Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood
•sample with simultaneous follicle stimulating hormone (FSH) > 40
•MlU/mL and estradiol <40 pg/mL (<147 pmol/L) is confirmatory].
•Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT.
•Following confirmation of their post-menopausal status, they can
•resume use of HRT during the study without use of a contraceptive method.
•b. Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 of Protocol for an appropriate period of time (as determined by the product
•label or investigator) prior to the start of dosing to sufficiently minimise the risk of pregnancy at that point. Female subjects must agree to use contraception until 16 weeks after the last dose.
•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 14
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

排除标准

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•1. Non-Idiopathic MGN or other condition affecting the kidney: If the diagnosis of MGN is secondary to other conditions, or the subject has renal impairment from a condition that is not MGN. Causes of secondary MGN include (but are not limited to):
•Immune diseases: Systemic lupus erythematosus, diabetes mellitus; rheumatoid arthritis, Hashimoto’s disease, Grave’s disease, mixed connective tissue disease, Sjogren’s syndrome, primary biliary cirrhosis, bullous pemphigoid, small bowel
•enteropathy syndrome, dermatitis herpetiformis, ankylosing spondylitis, graft-versushost-disease, Guillain-Barré syndrome.
•Infectious or parasitic diseases: Hepatitis B, Hepatitis C, syphilis, filariasis, hydatid disease, schistosomiasis, malaria, leprosy.
•Drugs and toxins: Gold, penicillamine, non-steroidal anti-inflammatory agents, mercury, captopril, formaldehyde, hydrocarbons, bucillamine.
•Miscellaneous: Tumours (excluded with reasonable diligence), renal transplantation, sarcoidosis, sickle cell disease, Kimura disease, angiofollicular lymph node hyperplasia.
•2.Severely reduced or deteriorating kidney function: An eGFR at
•screening < 40 mL/min/1.73m2 (as determined by 4 variable version MDRD equation) or kidney function not stable (as defined by > 15% decrease in eGFR in 3 months before screening, unless due to medication change).
•3. Blood Pressure: Uncontrolled hypertension defined as blood pressure (BP) > 150/90 mm Hg (treatment target =140/80) as assessed by either :
•a. Blood pressures measured 3 times on each of at least 2 clinic visits during screening, after the patient has sat quietly for at least 5 minutes, with >50% of measurements being >150/90 or
•b. Average daytime blood pressure on a 24 hour ambulatory blood pressure monitor.
•4. Prior Therapy: Have received treatment with the therapies (as per protocol page 39-see table) at the times specified prior to Day 0:
•Corticosteroid dose represents prednisolone or prednisolone equivalent.
•5. Transplantation: Have history of a major organ transplant (e.g heart, lung, kidney,liver) or hematopoietic stem cell/marrow transplant.
•6. Cancer: Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
•7. Acute or chronic infection: Have required management of acute or chronic infections, as follows:
•Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria).
•Hospitalisation for treatment of infection within 60 days prior to Day 0.
•Use of parenteral (IV or IM) antibiotics (anti-bacterials, anti-virals, antifungals, or anti-parasitic agents) within 60 days prior to Day 0.
•8. Liver disease: Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
•9. Other diseases/conditions: Have clinical evidence of signi

研究者

发起方

GlaxoSmithKline Research and Development Ltd

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