A Multicenter, Randomized, Double Blind, Placebo Controlled, Proof of Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Weekly Subcutaneous MLN1202, in Improving Diabetic Nephropathy Subjects with Macroalbuminuria - MLN1202 75, 105, 150 mg as add-on to ACE/ARB to treat Diabetic Nephropathy

Takeda Development Centre Europe Limited0 个研究点目标入组 156 人开始时间: 2015年4月21日最近更新: 2018年12月10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: 156

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

性别: All

入选标准

•Subject eligibility is determined according to the following criteria:
•1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
•2. The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
•3. At the time of Screening the subject is male or female and aged 18-90 years inclusive at first dose of study medication.
•4. The subject was previously diagnosed with type 2 diabetes mellitus per ADA criteria.
•5. The subject has an estimated glomerular filtration rate based on serum creatinine (eGFR, determined by MDRD equation) of 25-59 mL/min/1.73 m(2) at Screening.
•6. The subject has been on a stable dose of ACE inhibitor or ARB for 8 weeks prior to Screening.
•7. The subject has residual albuminuria despite stable treatment with an ACE inhibitor or an ARB for at least 8 weeks prior to Screening (urine albumin:creatinine ratio [UACR] of > 300 mg/g creatinine, inclusive at Screening).
•8. The subject has HbA1c test result less than or equal to 10.5% at screening.
•9. Subject regularly using DPP4i or SGLT2 to treat diabetes has been on a stable dose and regimen within 2 months prior to Screening.
•10. All patients who are not surgically sterile or post-menopausal, or whose partners are not surgically-sterile or postmenopausal, must use two effective birth control methods or abstain from intercourse during this study.
•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 62
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 94

排除标准

•Any subject who meets any of the following criteria will not qualify for entry into the study:
•1. Subject has received any investigational compound within 90 days prior to Screening.
•2. The subject is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
•3. Subject is taking any combination of dual RAS inhibition (such as an ACE inhibitor and an ARB or an ACE inhibitor and a mineralocorticoid receptor antagonist).
•4. Subject has type 1 diabetes mellitus or a history of ketoacidosis.
•5. Subject has poorly-controlled blood pressure (systolic blood pressure >160 or diastolic blood pressure >110, with blood pressure measured in the seated position after at least 5 minutes of rest) at Screening and Day 1.
•6. Subject has received dialysis within 3 months of Screening.
•7. Subject has infectious diseases or leg ulcers at Screening (all per discretion of Principal Investigator [PI]).
•8. Subject has severe concurrent disease which, in the judgment of the investigator, would interfere significantly with the assessments of safety and efficacy during this study.
•9. Subject with known infection with human immunodeficiency virus (HIV), or a positive test for Hepatitis B, Hepatitis C, or TB at Screening.
•10. Subject has used long-term immune suppressants, steroid therapy (except for topical use or inhalation), chronic use of non-steroidal anti-inflammatory drug (NSAIDs), cyclooxygenase type 2 (COX-2) inhibitors within 2 weeks prior to Screening. Short-term use is defined as a duration of =4 weeks of continuous use.
•11. In the judgment of the principal investigator, patients who are likely to be non-compliant or uncooperative during the study.
•12. Subjects with known non-diabetic kidney disease (such as autosomal dominant polycystic kidney disease (ADPCKD), IgA nephropathy, focal segmental glomerulosclerosis, or obstructive uropathy). Hypertensive nephrosclerosis superimposed on diabetic kidney disease is acceptable.
•13. Subject had a previous renal transplant.
•14. Subject has hypersensitivity to other monoclononal antibodies (mAb) or to any component of the formulation of MLN1202.
•15. The subject has history of malignancy within the previous 5 years (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
•16. Subject is symptomatic with dysuria, and has a positive urine culture at screening.

研究者

发起方

Takeda Development Centre Europe Limited

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