An open label, multicentric, non-comparative clinical study to investigate the efficacy, safety and tolerability of Sucroferric Oxyhydroxide Chewable Tablet (Dynultaâ„¢) in patients with chronic kidney disease on dialysis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 4
- 主要终点
- Evaluate efficacy of Sucroferric Oxyhydroxide Chewable Tablet by Change in serum
研究概览
简要总结
An open label, multicentric, non-comparative clinical phase IV study to investigate the efficacy, safety and tolerability of Sucroferric Oxyhydroxide Chewable Tablet (Dynultaâ„¢) in patients with chronic hemo dialysis (male and female) with chronic kidney disease. Total 117 subjects who are fulfilling inclusion criteria will be enrolled in the study. Subjects with a history of hyperphosphataemia (HP) will be selected for the study.
Screened subjects will be evaluated and the eligible subjects will be enrolled in the study. The subjects will be followed up for day 28, 56 and 84. The vital signs (blood pressure, pulse rate, body temperature and respiratory rate) will be recorded at the time of screening visit and during all study visits throughout the study. The primary endpoint assessment will be efficacy of Sucroferric Oxyhydroxide Chewable Tablet by change in serum phosphorus level from baseline to each visit. The secondary assessment endpoint include change from baseline in CBC, bio-chemistry (SGOT, SGPT and glucose), and serum calcium serum iPTH (intact parathyroid hormone) at week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female adult subjects (aged ≥18 years at time of consent) receiving maintenance haemodialysis (HD) for at least 12 weeks prior to screening.
- •Subjects with a history of hyperphosphataemia (HP).
- •Subjects with serum phosphorus levels >5.5 mg/dl (>1.78 mmol/l) at screening.
- •Subjects with the ability to understand the requirements of the study and abide by the study restrictions, and who agree to return for the required assessment.
- •Subject willing to provide and sign written informed consent.
排除标准
- •Subjects with intact parathyroid hormone (iPTH) levels >800 ng/l (>800 pg/ml or 88 pmol/l) at screening.
- •Subjects with planned or expected parathyroidectomy within the next 6 months.
- •Subjects with serum total calcium >10.5 mg/dl (>2.6 mmol/l) or <7.6 mg/dl (1.9 mmol/l) at screening.
- •Clinically significant, active GI disorders (e.g., active peptic ulcer, Crohns disease, colitis ulcerative, irritable bowel syndrome, intestinal motility disorder (symptomatic gastroparesis (during treatment or untreated), intestinal obstruction, moderate/severe constipation (including persistent symptoms with regular use of laxatives or enemas and limitations in activities of daily living), intestinal pseudo-obstruction, megacolon, mechanical obstruction)) or any GI disorders under medical treatment.
- •Clinically significant, active hepatic disorders or any hepatic disorder under medical treatment.
- •Subjects currently with: Swallowing difficulties/dysphagia.
- •Estimated life expectancy of less than 12 months Anticipated renal transplantation during study participation.
- •Subjects with a history of Haemochromatosis or other iron accumulation disorders that might lead to iron overload.
- •Subjects with raised alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of the normal range at screening.
- •Subject taking any prohibited medication which cannot be stopped at least one week before study treatment start.
- •Prohibited medications include: oral calcium supplements, any drugs / agents having a phosphate binding action that contain aluminium, magnesium or calcium (apart from hyperkalaemia drugs) phosphate binders in addition to sevelamer carbonate), nicotinamide, oral iron products, oral vitamins containing iron and other oral iron containing supplement.
- •Subject has known hypersensitivity and/or intolerance to any of the study products to be administered.
- •Subject has previously been randomized into this study.
- •Subject is currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening, or is receiving other investigational agent.
- •Subjects who are pregnant (e.g., positive human chorionic gonadotropin test) or breastfeeding.
- •Subjects of childbearing potential, not using adequate contraceptive precautions must agree to use a highly effective method of birth control during the study and for 1 month after the last dose of study medication.
- •Subject has a history of drug or alcohol abuse within 2 years.
- •Subject has a significant medical conditions or anticipated need for major surgery during the study, which may be associated with increased risk to the subject, may be associated with increased risk to the subject, may be associated with increased risk to the subject.
结局指标
主要结局
Evaluate efficacy of Sucroferric Oxyhydroxide Chewable Tablet by Change in serum
时间窗: 93 days
phosphorus level from baseline to each visit
时间窗: 93 days
次要结局
- Frequency of AEs determined by seriousness, severity and relatedness to(study drugs.)