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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-001787-23-EE
• Date of registration: 07/08/2009
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public 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
• Scientific 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
• Date of first enrolment: 07/09/2009
• Target sample size: 378
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001787-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: Stratified per serum phosphorus levels (= to 75.mg/dL) If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Belgium, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
- Men or women of at least 18 years old.
- Patient must be treated with a stable maintenance hemodialysis
- Patient must be on restricted phosphate diet at screening and throughout the study.
- Patient has a controlled serum phosphate > 3.0 mg/dL (> 0.97 mmol/L) and < 6.0 mg/dL (< 1.9 mmol/L)
- Patient has a serum phosphate level > 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation.
- Patient must have a Urea Reduction Ratio of > 65% (obtained within 2 weeks prior to screening)
- If patient has a history of parathyroidectomy, iPTH and calcium-phosphate product levels should be stable within 30 days prior to screening.
- Patient must be on a stable phosphate binder dose.
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:
?? Patient is on peritoneal dialysis or a non-conventional hemodialysis technique (e.g. hemofiltration, hemodiafiltration)
?? Patient has a parathyroidectomy or transplant scheduled during the study.
?? Patient has an uncontrolled hyperparathyroidism
?? Patient has a history of hemochromatosis or ferritin > 800 µg/L.
?? Patient has a clinically significant GI disorder
?? Patient has a chronic unstable GI disorder
?? Patient has an history of major gastrointestinal tract surgery
?? Patient is / has been treated with sevelamer HCl monotherapy or SBR759 within 3 months prior to screening.
?? History of intolerance to sevelamer HCl.
?? Patient is currently being treated with oral iron.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Hyperphosphataemia in patients with Chronic Kidney Disease (CKD) on hemodialysis
MedDRA version: 9.1 Level: LLT Classification code 10020712 Term: Hyperphosphatemia

Intervention(s)

Product Name: Not available
Product Code: SBR759
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: not yet established
Current Sponsor code: SBR759-NXA 001
Other descriptive name: Fe(OH)+ Starch + saccharose complex
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-3

Trade Name: Renagel
Product Name: Renagel
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sevelamer
CAS Number: 52757-95-6
Other descriptive name: sevelamer hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-

Primary Outcome(s)

Primary end point(s): Number of patients with a serum phosphate level below or equal to 5.5 mg/dL (1.78 mmol/L)

Main Objective: This study is designed to demonstrate superior or at least non-inferior
efficacy of SBR759 in phoshate binding, versus sevelamer HCl and evaluate safety over a long term exposure. Efficacy will be measured by the number of patients with a serum phosphate level below or equal to 5.5 mg/dl (i.e. 1.78 mmol/L) at 12 weeks

Secondary Objective: To evaluate safety and tolerability of SBR759 compared to sevelamer HCl over a 12-week period.
To evaluate whether SBR759 has superior efficacy at week 12 compared to sevelamer HCl, as measured by the number of patients with a serum calcium-phosphate product levels below or equal to 55 mg2/dL2.

Secondary ID(s)

2006-001787-23-FR

CSBR759A2201