CTRI/2017/07/009179已完成2 期
A Randomized, Double Blind, Placebo Controlled, Phase 2 Study to Assess the Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of LNP1892 (Monotherapy) in Chronic Kidney Disease (CKD) Patients with Secondary Hyperparathyroidism (SHPT), On Dialysis and Not on Dialysis
upin Limited0 个研究点目标入组 189 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 189
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
- •1) Ambulatory patients of either gender with >=18 years of age with diagnosis of SHPT associated with CKD, with Estimated Glomerular Filtration Rate (eGFR) <30 and willing to provide informed consent
- •2) CKD (Stage 4 & 5) patients with SHPT, on Hemodialysis (or) Not on Hemodialysis and fulfilling additional criteria given below.
- •CKD Patients not on Hemodialysis -
- •1. Patients with mean of 2 intact parathyroid hormone (iPTH) values obtained during the screening period >=110 pg/mL/ 12.1 pmol/L (CKD stage 4) or >=300 pg/mL/ 33 pmol/L (CKD stage 5)
- •CKD Patients on Hemodialysis
- •1. Patients must be receiving maintenance hemodialysis 3 times weekly OR a minimum of 10 hemodialysis/ month for at least 3 months
- •2. Patients with mean of 2 intact parathyroid hormone (iPTH) values obtained during the screening period at least 300 pg/mL (33 pmol/L) and not greater than 1200 pg/mL (132 pmol/L)
- •3. Patients who have not used cinacalcet or are justified to shift from current cinacalcet use for any of the following reasons -
- •1 > Patients not tolerating cinacalcet:
- •a. Nausea/ Vomiting
- •b. Hypocalcemia (serum corrected calcium <8.4 mg/dl)
- •c. Paraesthesia
- •d. Any other adverse events not tolerated by the patient
- •2 > Patients not responding to cinacalcet:
- •a. Patients who fail to achieve PTH goal of <300 pg/ml after full titration
- •b. Less than 30% reduction from baseline PTH levels after 3 months of treatment
- •c. Patients with PTH more than 800 pg/ml while being on cinacalcet
- •3) Patients who are on stable doses of active vitamin D or vitamin D analogues/ sterols (e.g. calcitriol, alfacaidol, paricalitol, or doxercalciferol) and/or phosphate binders for at least 3 weeks prior to Day 1
- •4) Patients who are on stable doses of calcium supplements for at least 1 week prior to Day 1
- •5) Patients must not have taken cinacalcet within 21 days prior to Day 1
- •6) Patients with mean of 2 corrected total serum calcium values obtained during the screening period >=8.4 mg/dL (2.10 mmol/L)
- •7) Patients with hemoglobin >=8.0 g/dL
- •8) Patients with serum magnesium level above the lower limit of normal
- •9) Participants of reproductive potential (males and females), must be willing to use a reliable means of contraception (combined or progesterone only hormonal contraception, intrauterine devices, surgical sterilization, double barrier methods, or vasectomized partner) throughout trial participation and 3 month after the last dose of IP; OR
- •Women if postmenopausal (aged greater than 45 years) must have a history of amenorrhea for at least 1 year from the time of last menstrual cycle and have follicle stimulating hormone (FSH) value indicating menopause with high reliability.
- •10) Patient is in stable condition and has life expectancy of at least 6 months in the judgement of the investigator
排除标准
- •1. History of Primary hyperparathyroidism
- •2. Subject has known sensitivity to any of the products or components to be administered during dosing.
- •3. Anticipated or scheduled kidney transplant during the study period.
- •4. Parathyroidectomy within 3 months prior to screening or parathyroid surgery is planned or anticipated during the study
- •5. Change in dialysate calcium concentration in the 30 days prior to Day 1
- •6. Patients on peritoneal dialysis
- •7. History of symptomatic ventricular dysrhythmias or torsades de pointes, uncontrolled hypertension, symptoms of angina pectoris at rest or minimal activity, congestive heart failure (New York Heart Association Class III or IV ), history of myocardial infarction, coronary angioplasty, coronary arterial bypass grafting within 6 months prior to screening
- •8. Treatment of a seizure disorder or history of seizure in the last 12 months prior to screening.
- •9. Participation in another investigational trial in the past 1 month prior to screening.
- •10. Women who are pregnant, lactating, or planning pregnancy while enrolled in the study and at least 3 month after last dose of the IP
- •11. History of any immunosuppressive or biologic response modifiers therapy within 6 months prior to screening
- •12. History of abuse of alcohol or recreational drugs within 1 year prior to screening
- •13. Tested seropositive for Hepatitis B [Hepatitis B surface antigen (HBsAg)], and Hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- •14. Have any known condition affecting oral absorption of drug e.g., (malabsorption syndrome), or not able to swallow IP for any reason
- •15. Patient has current or recent history of a severe, progressive, or uncontrolled disease or an unstable medical condition (apart from disease under investigation) based on medical history, physical examination or any clinically significant laboratory/investigation findings, which in the opinion of investigator makes the patient inappropriate for inclusion in this study.
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