Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy Clinical Trial
— SBR759Official title:
A 12-week, Open Label, Multicenter, Titration Study, With a 9-month Maintenance Treatment Extension, to Demonstrate Efficacy of SBR759 Compared to Sevelamer HCl in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
| NCT number | NCT00704483 |
| Other study ID # | CSBR759A2201 |
| Secondary ID | EUDRACT No.: 200 |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | July 2008 |
| Verified date | November 2016 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis
| Status | Completed |
| Enrollment | 321 |
| Est. completion date | |
| Est. primary completion date | August 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis | Adelaide | South Australia |
| Australia | Novartis | Fitzroy | Victoria |
| Australia | Novartis | Melbourne | |
| Australia | Novartis | Parkville | Victoria |
| Australia | Novartis | South Brisbane | |
| Australia | Novartis | Woolloongabba | |
| Belgium | Novartis Investigative Site | Antwerpen | |
| Belgium | Novartis | Brugge | |
| Belgium | Novartis | Bruxelles | |
| Belgium | Novartis | Liege | |
| Belgium | Novartis Investigative Site | Saint Niklaas | |
| Canada | Novartis Investigative Site | Edmonton | |
| Canada | Novartis Investigative Site | London | |
| Canada | Novartis Investigative Site | Oshawa | |
| Canada | Novartis Investigative Site | Quebec | |
| Finland | Novartis | Helsinki | |
| Finland | Novartis | Oulu | |
| Finland | Novartis | Tampere | |
| Finland | Novartis | Turku | |
| France | Novartis | Amiens | |
| France | Novartis | Fleury Merogis | |
| France | Novartis | Lyon Cedex | |
| France | Novartis | Rheims Cedex | |
| France | Novartis | Salouel | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Coburg | |
| Italy | Novartis Investigative Site | Lecco | |
| Italy | Novartis Investigative Site | Lodi | |
| Italy | Novartis Investigative Site | Milano | |
| Italy | Novartis Investigative Site | Modena | |
| Italy | Novartis Investigative Site | Pavia | |
| Norway | Novartis | Bergen | |
| Norway | Novartis | Kristiansand | |
| Norway | Novartis | Oslo | |
| Norway | Novartis | Tonsberg | |
| Puerto Rico | Novartis | San Juan | |
| Sweden | Novartis Investigative Site | Jonkoping | |
| Sweden | Novartis Investigative Site | Karlstad | |
| Sweden | Novartis Investigative Site | Skovde | |
| Sweden | Novartis Investigative Site | Stockholm | |
| Switzerland | Novartis | Aarau | |
| Switzerland | Novartis | Lausanne | |
| Switzerland | Novartis | Zurich | |
| United Kingdom | Novartis | Hull | |
| United Kingdom | Novartis Investigative Site | Manchester | |
| United Kingdom | Novartis Investigative Site | Portsmouth | |
| United Kingdom | Novartis | Salford | |
| United States | Novartis | Baltimore | Maryland |
| United States | Novartis | Chula Vista | California |
| United States | Novartis | Denver | Colorado |
| United States | Novartis | Fairfax | Virginia |
| United States | Novartis | Fall River | Massachusetts |
| United States | Novarits | Fargo | North Dakota |
| United States | Novartis Investigative Site | Houston | Texas |
| United States | Novartis | La Mesa | California |
| United States | Novartis | Mishawaka | Indiana |
| United States | Novartis | New York | New York |
| United States | Novartis | North Chicago | Illinois |
| United States | Novartis Investigative Site | Omaha | Nebraska |
| United States | Novartis | Peoria | Illinois |
| United States | Novartis | Pittsburgh | Pennsylvania |
| United States | Novartis | Portland | Oregon |
| United States | Novartis | San Antonio | Texas |
| United States | Novartis | Springfield | Massachusetts |
| United States | Novartis | Whittier | California |
| United States | Novartis | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Australia, Belgium, Canada, Finland, France, Germany, Italy, Norway, Puerto Rico, Sweden, Switzerland, United Kingdom,
Chen JB, Chiang SS, Chen HC, Obayashi S, Nagasawa M, Hexham JM, Balfour A, Junge G, Akiba T, Fukagawa M. Efficacy and safety of SBR759, a novel calcium-free, iron(III)-based phosphate binder, in Asian patients undergoing hemodialysis: A 12-week, randomize — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months | Time Frame: 12 weeks / 12 months |