Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Sucroferric Oxyhydroxide Chewable Tablet (Dynulta™): DynultaTM contains 500 mg iron (equivalent to 2500 mg
sucroferric oxyhydroxide). One tablet 3 times a day for 12 weeks. Dose increa
Sponsors
Emcure Pharmaceuticals Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 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 screening. 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate efficacy of Sucroferric Oxyhydroxide Chewable Tablet by Change in serum phosphorus level from baseline to each visitTimepoint: 93 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of AEs determined by seriousness, severity and relatedness to study drugs. Change from baseline in CBC, bio-chemistry (SGOT, SGPT and glucose), and serum calcium serum iPTH (intact parathyroid hormone) at week 12.Timepoint: 93 days | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Services
Outcome results
None listed