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: 26 November 2013
• Main ID: EUCTR2006-001787-23-BE
• Date of registration: 17/06/2008
• 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: 25/06/2008
• 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 ON maintenance RENAL REPLACEMENT THERAPY (I.E. hemodialysis, HEMOFILTRATION OR HEMODIAFILTRATION)
- Patient must be on restricted phosphate diet at screening and throughout the study.
- IF CURRENTLY UNDER PHOSPHATE BINDER THERAPY patient has a controlled serum phosphate > 3.0 mg/dL (> 0.97 mmol/L) and < 6.5 mg/dL (< 2.1 mmol/L)...AS INDICATED BY SINGLE VALUE OBTAINED FROM THE CENTRAL LABORATORY AT SCREENING (I.E. OBTAINED AT A 72 HR POST-DIALYSIS INTERVAL)
- Patient has a serum phosphate level > 6.0 mg/dL (> 1.9 mmol/L) OBTAINED AT A 72 HR POST-DIALYSIS INTERVAL) FROM A CENTRAL LABORATORY PRIOR TO RANDOMISATION AND TREATMENT INITIATION 9I.E. AFTER 2 WEEKS WASHOUT IF NO EXEMPTION IS APPLICABLE.
- Patient must have a Urea Reduction Ratio of > 60% (obtained FROM A CENTRAL LABORATORY AT screening)
- Patient must be on a stable phosphate binder dose OR NOT HAVE RECEIVED PHOSPHATE BINDER THERAPY FOR AT LEAST 4 WEEKS PRIOR TO SCREENING.
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
?? Patient has a parathyroidectomy WITHIN 3 M PRIOR TO SCREENING or transplant scheduled during the study.
?? Patient has an uncontrolled hyperparathyroidism OBTAINED FROM A CENTRAL LABORATORY AT SCREENING
?? Patient has a history of hemochromatosis or serum ferritin > 1000 800 µg/L OBTAINED FROM CENTRAL LABORATORY AT SCREENING
?? Patient has a clinically significant GI disorder
?? Patient has a chronic unstable GI disorder
?? Patient has an history of major gastrointestinal tract surgery
?? History of intolerance to sevelamer HCl.
?? Patient is currently being treated with oral iron.
?? PATEINT IS TREATED WITH OSTEOPOROSIS TREATMENT WITHIN 30 DAYS PRIOR TO SCREENING PATIENT HAS A TRANSFERRIN SATURATION >60% OBTAINED FROM CENTRAL LAB AT SCREENING.


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: SBR759
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: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Trade Name: Renagel
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sevelamer hydrochloride
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 800-

Product Name: SBR759
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: mg milligram(s)
Concentration type: equal
Concentration number: 1500-

Product Name: SBR759
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: mg milligram(s)
Concentration type: equal
Concentration number: 3000-

Primary Outcome(s)

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.

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

Secondary ID(s)

2006-001787-23-FR

CSBR759A2201