EUCTR2011-003049-16-NL进行中（未招募）不适用
A Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Effect of CCX140-B on Albuminuria in Subjects with Type 2 Diabetes Mellitus - CCX140-B T2DM albuminuria
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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.Male or female, aged 18-75 years inclusive, with documented previously diagnosed type 2 diabetes mellitus (per American Diabetes Association [ADA] criteria), and treated with oral antidiabetic drugs;
- •2.Albumin:creatinine ratio (ACR) of 200 to 3000 mg/g creatinine, inclusive, based on two values obtained from two first morning urine samples taken on two separate days during the screening period; both ACR values must be 200 to 3000 mg/g creatinine, inclusive;
- •3.Estimated glomerular filtration rate based on serum creatinine (eGFR, determined by Modification of Diet in Renal Disease [MDRD] equation) of = 25 mL/min/1.73 m2;
- •4.All subjects must be on a stable dose an ACE inhibitor or ARB for at least 8 weeks prior to screening. The dose of these drugs must not be lower than the lowest labeled dose. Subjects may not be on both an ACE inhibitor and an ARB. Doses of any other anti-hypertension treatment must have been stable for at least 4 weeks prior to screening;
- •5.If taking any phosphate binders, cinacalcet, vitamin D or vitamin D analogues, must have been on stable doses for at least 4 weeks prior to screening;
- •6.Fasting plasma glucose less than 270 mg/dL at screening;
- •7.Willing and able to give written Informed Consent and to comply with the requirements of the study protocol;
- •8.Judged to be otherwise healthy by the Investigator, based on medical history, physical examination (including electrocardiogram [ECG]), and clinical laboratory assessments. Subjects with clinical laboratory values that are outside of normal limits (other than those specified in the Exclusion Criteria) and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance, may be entered into the study; and
- •9.Female subjects of childbearing potential, and male subjects with partners of childbearing potential, may participate if adequate contraception is used during, and for at least the four weeks after, any administration of study medication. Adequate contraception is defined as usage by at least one of the partners of a barrier method of contraception, together with usage by the female partner, commencing at least three months prior to Screening, of a stable regimen of any form of hormonal contraception or an intra-uterine device. Use of abstinence alone is not considered adequate. Use of a barrier method alone is considered adequate only if the male partner was vasectomized at least six months prior to Screening. Use of a double-barrier method of contraception is acceptable. Women of childbearing potential must have a negative serum pregnancy test during the screening period and a negative urine pregnancy test on the day prior to the initial dosing.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Type 1 diabetes mellitus or history of diabetic ketoacidosis;
- •2.Previous renal transplant or known non-diabetic renal disease, except related to hypertension;
- •3.Has undergone renal dialysis at any time in the past;
- •4.Women who are pregnant or breastfeeding;
- •5.Body mass index (BMI) above 45.4 kg/m2;
- •6.Received chronic (more than 7 days continuously) systemic glucocorticoid or other immunosuppressive treatment within 8 weeks of screening;
- •7.Use of bardoxolone, atrasentan or other endothelin antagonist within 8 weeks of screening;
- •8.Received chronic (more than 7 days continuously) NSAID treatment within 2 weeks of screening;
- •9.Cardiac failure (class III or IV), history of unstable angina, symptomatic coronary artery disease, myocardial infarction or stroke within 12 weeks of screening;
- •10.Poorly-controlled blood pressure (systolic blood pressure >155 or diastolic blood pressure >95, with blood pressure measured in the seated position after at least 5 minutes of rest);
- •11.History of hypersensitivity to ingredients of the placebo (tartrazine, microcrystalline cellulose, starch, or croscarmellose sodium);
- •12.History or presence of leukopenia (WBC count <3.5 x 109/L);
- •13.History or presence of any form of cancer within the 5 years prior to randomization, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis;
- •14.Presence of tuberculosis based on chest X rays, tuberculin skin test, QuantiFERON®-TB Gold test, or T-SPOT®.TB test performed during screening; If screening test is performed and it is deemed positive due to previous vaccination or TB exposure, chest X rays must be acquired to rule out TB;
- •15.Positive HBV, HCV, or HIV viral screening test;
- •16.History of gastrointestinal conditions that may interfere with study medication compliance, e.g., severe gastroparesis, with regurgitation of food or oral medication;
- •17.History of alcohol or illicit drug abuse;
- •18.Any infection requiring antibiotic treatment within 4 weeks of screening;
- •19.Hemoglobin less than 10 g/dL (or 6.18 mmol/L) at screening;
- •20.Evidence of hepatic disease; AST, ALT, or bilirubin > 2 x the upper limit of normal;
- •21.Clinically significant abnormal ECG during screening, e.g., QTc greater than 450 msec;
- •22.Participation in another clinical trial within 3 months prior to the start of this study or more than 4 times per year; and
- •23.History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation.
研究者
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