Clinical trial NCT01069692: Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients
Official title: A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperphosphatemia
Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Hemodialysis
Hyperphosphatemia
Hyperphosphatemia patients with chronic kidney disease on 3x/week hemodialysis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.


Eligibility criteria: Inclusion criteria:

1. Men or women of at least 18 years of age
2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater
3. Controlled serum phosphate if under phosphate-binder therapy
4. Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening

Exclusion criteria:

1. Patients who are on peritoneal dialysis
2. Patients who have a transplant or parathyroidectomy scheduled during the study
3. Clinically significant GI disorder
4. Unstable medical condition other than Chronic Kidney Disease
5. Patient is currently being treated with oral iron
6. History of hemachromatosis, or ferritin \> 1000 ng/mL
7. Transferrin saturation \> 60%
8. Uncontrolled hyperparathyroidism (iPTH \> 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment
timeFrame: 6 weeks
measure: Evaluate dose-dependent efficacy of SBR759
timeFrame: 6 weeks
measure: Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Roeselare
country: Belgium
facility: Novartis Investigative Site
city: Brescia
country: Italy
facility: Novartis Investigative Site
city: Lecco
country: Italy
facility: Novartis Investigative Site
city: Lucca
country: Italy
facility: Novartis Investigator Site
city: Napoli
country: Italy
facility: Novartis Investigative Site
city: Pavia
country: Italy
facility: Novartis Investigative Site
city: Siena
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmceuticals
role: STUDY_DIRECTOR
References:
citation: Fukagawa M, Kasuga H, Joseph D, Sawata H, Junge G, Moore A, Akiba T. Efficacy and safety of SBR759, a novel calcium-free, iron (III)-based phosphate binder, versus placebo in chronic kidney disease stage V Japanese patients on maintenance renal replacement therapy. Clin Exp Nephrol. 2014 Feb;18(1):135-43. doi: 10.1007/s10157-013-0815-7. Epub 2013 May 15.