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.

Emcure Pharmaceuticals Ltd India0 个研究点目标入组 94 人开始时间: 待定最近更新: 2023年7月25日

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 94

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

入排标准

入选标准

•1. Male and female adult subjects (aged >=18 years at time of consent) receiving maintenance haemodialysis (HD) for at least 12 weeks prior to screening.
•2. Subjects with a history of hyperphosphataemia (HP).
•3. Subjects with serum phosphorus levels >5.5 mg/dl ( >1.78 mmol/l) at screening.
•4. 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.
•5. Subject willing to provide and sign written informed consent.

排除标准

•1. Subjects with intact parathyroid hormone (iPTH) levels >800 ng/l ( >800 pg/ml or 88 pmol/l) at screening.
•2. Subjects with planned or expected parathyroidectomy within the next 6 months.
•3. Subjects with serum total calcium >10.5 mg/dl ( >2.6 mmol/l) or <7.6 mg/dl (1.9 mmol/l) at screening.
•4. Subjects with:
•Subjects with:
•Any history of major gastrointestinal (GI) surgery.
•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.
•5. Subjects currently with:
•Swallowing difficulties/dysphagia.
•Estimated life expectancy of less than 12 months
•Anticipated renal transplantation during study participation.
•6. Subjects with a history of Haemochromatosis or other iron accumulation disorders that might lead to iron overload.
•7. Subjects with raised alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of the normal range at
•8. 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.
•9. Subject has known hypersensitivity and/or intolerance to any of the study products to be administered.
•10. Subject has previously been randomized into this study.
•11. 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.
•12. Subjects who are pregnant (e.g., positive human chorionic gonadotropin test) or breastfeeding.
•13. 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.
•14. Subject has a history of drug or alcohol abuse within 2 years.
•15. 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.

研究者

发起方

Emcure Pharmaceuticals Ltd India

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