Status:
COMPLETED
Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00704483
Start Date
July 1 2008
Last Update
December 19 2020
Active Locations (66)
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1
Novartis
Chula Vista, California, United States, 91910
2
Novartis
La Mesa, California, United States, 91942
3
Novartis
Whittier, California, United States, 90602
4
Novartis
Denver, Colorado, United States, 80262