EUCTR2012-004496-40-GB进行中（未招募）1 期
Study of the Safety and Efficacy of LY3016859 after Multiple Intravenous Dosing in Diabetic Nephropathy Patients - TGAB
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •1.Stable DKD while taking SOC, as defined by:
- •a.Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73m2 as determined utilizing the Modification of Diet in Renal Disease (MDRD) equation (Levey et al. 2006)
- •b.Taking ACE inhibitor or ARB at a stable dose for = 2 months prior to randomization and agree to continue to take such throughout the duration of the study
- •c.Type 1 or Type 2 diabetes on a stable treatment regimen and adequately controlled in opinion of investigator
- •d.First morning protein creatinine ratio (PCR) at screening = 400 mg/g (Part B only)
- •2.Clinical chemistry labs within acceptable range for the patient population, as per investigator judgment
- •3.Men and women of non-childbearing potential as determined by medical history
- •a.Non-vasectomized male patients must agree to use a medically accepted method of contraception with all sexual partners during the study and for 90 days following the final dosing. Medically accepted effective forms of contraception may include condoms with contraceptive foam or having partners use diaphragms with contraceptive jelly or cervical caps with contraceptive jelly.
- •b.Female patients must be postmenopausal or surgically sterile to particpate in this study. Postmenopausal is defined as females between age 45 to 75 years, inclusive, and either 12 months without a menstrual period (no follicle-stimulating hormone [FSH] test required) or 6-12 months without a menstrual period and FSH >40 IU/L
- •4.18-75 years old, inclusive and must weigh = 50 kg at time of screening and dosing.
- •5.Acceptable sitting blood pressure per the following American Heart Association guidelines
- •a.Normal: Systolic Blood Pressure (SBP) <120 mmHg and Diastolic Blood Pressure (DBP) <80 mmHg
- •b.Prehypertension: SBP 120 139 mmHg or DBP 80 89 mmHg
- •c.High Blood Pressure (Hypertension) Stage 1: SBP 140 159 mmHg or DBP 90 99 mmHg
- •6.Have given written informed consent prior to any study-specific procedures.
- •7.Are reliable and willing to make themselves available for the duration of the study and are willing to follow site specific study procedures.
- •8.Have venous access sufficient to allow blood sampling as per the protocol.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1.Patients with diagnosis of CKD other than DKD (hypertensive nephrosclerosis superimposed on DKD is acceptable)
- •2.Patients with SBP >160 mmHg or DBP >100 mmHg,
- •a.Individuals with Stage I BP elevation (SBP 140 159 mmHg or DBP 90 99 mmHg) on some occasions during study, may be acceptable, as long as only non-protein-lowering antihypertensives are administered/adjusted to achieve target BP goals (<140/90 mmHg).
- •3.Patients with current use of (or within 2 weeks of enrollment), or projected need for a renin inhibitor or aldosterone antagonist, or a combination of ACEi/ARB or medications that confound the assessment of renal function, including lithium, immunosuppressives, anti-vascular endothelial growth factor (VEGF) therapies, and chronic nonsteroidal antiinflammatory drugs (NSAIDs); Patients who are unwilling to discontinue use of any medication with potential risk to mask a significant allergic response (e.g. systemic glucocorticoids) within 3 days of dosing;
- •4.Patients in whom dialysis or transplantation is anticipated within 6 months of screening
- •5.Patients with history of acute kidney injury within 3 months of screening
- •6.Patients who are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational drug that has not received regulatory approval for any indication and/or have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives of the administered drug (whichever is longer) prior to dosing
- •7.Patients who have previously completed or withdrawn from this study or any other study investigating LY3016859
- •8.Patients with a diagnosis of Class III or IV congestive heart failure (as defined by the New York Heart Association); active/significant skin disorders (dermatitis, rash, acne, psoriasis), lung diseases (asthma, COPD, interstitial lung disease), or ocular disorders affecting sclerae, conjunctiva or iris (scleritis, conjunctivitis, keratoconjunctivitis, uveitis).
- •9.Patients with an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study. In addition, subjects with the following findings will be excluded:
- •a.Confirmed corrected QT (QTcF) interval > 450 msec for men and > 470 msec for women; additional ECGs may be performed if required
- •b.Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular ectopic beats
- •c.History of unexplained syncope
- •d.Family history of unexplained sudden death or sudden death due to long QT syndrome
- •e.T-wave configurations are not of sufficient quality for assessing QT interval, as determined by the investigator
- •10.Patients with evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies; patients with a history of cirrhosis or hepatitis C or are positive for hepatitis C antibody at the screening visit; patients who are known to be hepatitis B surface antigen-positive or are positive for hepatitis B surface antigen at the screening visit
- •11.Patients who are unwilling to discontinue use of Chinese herbs for at least 2 weeks prior to randomization and for the duration of their study pa
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