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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2006-001787-23-LT |
Date of registration:
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13/07/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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19/10/2009 |
Target sample size:
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378 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001787-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Belgium
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Estonia
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Finland
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France
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Germany
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Italy
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Latvia
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Lithuania
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Spain
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Sweden
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United Kingdom
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Hyperphosphataemia in patients with Chronic Kidney Disease (CKD) on hemodialysis MedDRA version: 12.0
Level: LLT
Classification code 10064848
Term: Chronic kidney disease
MedDRA version: 12.0
Level: LLT
Classification code 10020712
Term: Hyperphosphatemia
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Intervention(s)
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Product Name: Not available Product Code: SBR759 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: not yet established CAS Number: n/a Current Sponsor code: SBR759-NXA 001 Other descriptive name: Fe(OH)+ Starch + saccharose complex Concentration unit: g gram(s) Concentration type: equal Concentration number: 1.0-
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: g gram(s) Concentration type: equal Concentration number: 0.8-
Product Name: Not available Product Code: SBR759 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: not yet established CAS Number: n/a Current Sponsor code: SBR759-NXA 001 Other descriptive name: Fe(OH)+ Starch + saccharose complex Concentration unit: g gram(s) Concentration type: equal Concentration number: 1.5-
Product Name: Not available Product Code: SBR759 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: not yet established CAS Number: n/a Current Sponsor code: SBR759-NXA 001 Other descriptive name: Fe(OH)+ Starch + saccharose complex Concentration unit: g gram(s) Concentration type: equal Concentration number: 3-
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Primary Outcome(s)
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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
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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.
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Primary end point(s): Number of patients with a serum phosphate level below or equal to 5.5 mg/dL (1.78 mmol/L)
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Secondary ID(s)
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2006-001787-23-FR
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CSBR759A2201
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Source(s) of Monetary Support
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Results
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Results available:
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Date Completed:
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