hyperphosphataemia in chronic kidney disease patients on renal replacement therapy MedDRA version: 9.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease MedDRA version: 9.1 Level: LLT Classification code 10020712 Term: Hyperphosphatemia
Conditions
Interventions
Product Name: not applicable
Product Code: SBR759
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: 1. Fosferide or 2. Fosbindafer or 3. Feroxifer
CAS Number: 1041180-02-2
Current S
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men or women of at least 18 years of age willing to provide informed consent. Patient must be on maintenance renal replacement therapy (i.e. hemodialysis, hemodiafiltration or hemofiltration) 3 times per week for = 3 months and must be treated with a stable dialysis prescription, as defined by no change in material (filter/membrane) and dialysis duration of = 3hoursfor = 4 weeks before screening and planned to be maintained the same throughout the study duration. Patient has a serum phosphate level = 1.78 mmol/L (= 5.5 mg/dL) and =2.9mmol/L ( =9.0 mg/dL), obtained at a 72-hour post-dialysis interval, from the local laboratory, prior to randomization and study treatment initiation. Patient must have a Kt/V = 1.2 or urea reduction rate of =60% Patient must be on a stable phosphate binder dose (i.e. no change in prescribed dose) or not have received phosphate binder therapy for at least 4 weeks prior to screening. Patient must be on restricted phosphate diet at screening and throughout the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient is on peritoneal dialysis. Patient has a transplant scheduled during the study. Patient has an uncontrolled hyperparathyroidism (i.e. intact PTH > 800 pg/mL obtained from central laboratory at screening). Patient had a parathyroidectomy within 3 months prior to screening or scheduled during the study. Patient has a clinically significant (e.g. chronic unstable) GI disorder and/or has an history of major gastrointestinal tract surgery (e.g. gastrectomy, extensive bowel resection). Patient is currently being treated with oral iron. Patient has a history of hemochromatosis or serum ferritin = 1000 ng/mL obtained from central laboratory at screening. Patient has a transferrin saturation > 60% at screening, obtained from central lab. Patient has a clinically significant unstable medical condition (in the opinion of the investigator), other than Chronic Kidney Disease, that could negatively impact adequate study conduct or participation. Patient has a history of hemochromatosis or serum ferritin = 1000 ng/mL. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate changes in serum phosphate during a 2-week random treatment withdrawal period of SBR759 after 4 weeks treatment. To evaluate dose-dependent efficacy of SBR759. To compare the short-term safety profile and dose-dependent tolerability of SBR759, dosed TID with meals, to that of placebo. ;Primary end point(s): The primary efficacy variable is change from baseline in 72-hour serum phosphate at 4 weeks Supportive analyses of primary variable : Investigation of the response across SBR759 doses and with respect to placebo.;Main Objective: To evaluate the change from baseline in 72-hour serum phosphate of different doses of SBR759 versus placebo over 4 weeks of treatment. | — |
Countries
Czech Republic, Hungary, Italy, Lithuania
Outcome results
None listed