Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Sucroferric oxyhydroxide: 1.5 to 3 g iron per day for 12 weeks
Intervention2: Sucroferric oxyhydroxide: 1.5 to 3 g iron per day for 12 weeks
Control Intervention1: Sevelamer carbonate:
Sponsors
Indira Gandhi Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with CKD on dialysis aged equal to or more than 18 and less than or equal to 65 years. 2. Maintenance hemodialysis or peritoneal dialysis for equal to or more than 12 weeks prior to screening. 3. Hyperphosphataemia (serum phosphate more than 1.78 mmol/L [more than 5.5 mg/dl]) at screening or during washout.
Exclusion criteria
Exclusion criteria: 1. Intact parathyroid hormone (iPTH) levels more than 800 ng/L 2. Planned or expected parathyroidectomy within the next 6 months 3. Serum total calcium more than 2.6 mmol/L or less than 1.9 mmol/L; 4. History of haemochromatosis 5. Alanine aminotransferase or aspartate transaminase equal to or more than 3 times the upper limit of normal range; 6. Peritoneal dialysis with a history of peritonitis in the last 3 months or =3 episodes in the last 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving target-range serum phosphate level.Timepoint: At the end 8 and 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of serum phosphate level and its change from baseline. 2. Frequency of treatment-emergent AEs (TEAEs) and withdrawals due to TEAEs. 3. Average daily number of tablets taken by the patient. 4. Biochemical/haematological laboratory parameters including serum total calcium, serum intact parathyroid hormone (iPTH) and blood iron parameters at each time point and their change from baseline. Timepoint: At week 8, 12, 16 and 24. | — |
Countries
India
Contacts
Public ContactDr Lalit Mohan
Indira Gandhi Institute of Medical Sciences, Patna, Bihar, INDIA
Outcome results
None listed