Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy
Conditions
Keywords
Chronic Kidney Disease, hemodialysis, hyperphosphatemia, hemodiafiltration
Brief summary
This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis
Interventions
DRUGSBR759
Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.
DRUGSevelamer HCl
0.8 g tid
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men or women of at least 18 years old. * Stable maintenance of renal replacement therapy 3 times per week. * Controlled Serum phosphate if under phosphate-binder therapy. * Serum phosphate level ≥ 6.0 mg/dL (\> 1.9 mmol/L) prior to study treatment initiation.
Exclusion criteria
* Peritoneal dialysis. * Parathyroidectomy or transplant scheduled during the study. * Uncontrolled hyperparathyroidism * History of hemochromatosis or ferritin \> 1000 µg/L. * Clinically significant GI disorder * Unstable medical condition other than Chronic Kidney Disease. * Treated with oral iron. * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks | Time Frame: 12 weeks + 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months | Time Frame: 12 weeks / 12 months |
Countries
Australia, Belgium, Canada, Finland, France, Germany, Italy, Norway, Puerto Rico, Sweden, Switzerland, United Kingdom, United States
Outcome results
None listed