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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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24 April 2012 |
Main ID: |
EUCTR2009-011007-23-BE |
Date of registration:
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01/10/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A facilitated access open-label, non-randomized, multicenter,
long-term safety and efficacy study in Chronic
Kidney Disease patients treated with SBR759 who have
completed previous SBR759 studies
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Scientific title:
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A facilitated access open-label, non-randomized, multicenter,
long-term safety and efficacy study in Chronic
Kidney Disease patients treated with SBR759 who have
completed previous SBR759 studies |
Date of first enrolment:
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19/10/2009 |
Target sample size:
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500 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011007-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Belgium
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Finland
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France
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Italy
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Sweden
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients who have completed a dose-titration study on treatment with SBR759. 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: History of hypersensitivity to any of the study drug. History of malignancy of any organ system ( other than localized basal cell carcinoma of theskin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis. Pregnant or nursing (lactating) women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. UNLESS they are Women whose career, lifestyle, or sexual orientation precludes intercourse with male partner Women whose partners have been sterilized by vasectomy or other means Using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectibles, combined oral contraceptives, and some intrauterine devices (IUDs), Periodic abstinence(e.g. calendar, ovulation, symptothermal, post ovulation methods are not acceptable. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
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 haemodialysis
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Intervention(s)
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Product Name: SBR759 Product Code: SBR759 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: N/A CAS Number: 1041180-02-2 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 mg-
Product Name: SBR759 Product Code: SBR759 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: N/A CAS Number: 1041180-02-2 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 mg -
Product Name: SBR759 Product Code: SBR759 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: N/A CAS Number: 1041180-02-2 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 mg-
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Primary Outcome(s)
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Main Objective: To evaluate long term safety data in patients who have completed a clinical study on SBR759
(ie: to provide long term safety and efficacy data on patients who have been titrated to achieve phosphate target within Phase II/III studies of SBR759 and completed these studies on SBR759. In addition, the study will provide access to continued SBR759 maintenance therapy for these patients. The study is an open-label, non-randomized design where patients will continue on their currently assigned dose from the previous SBR759 study)
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Primary end point(s): To evaluate long term safety data in patients who have completed a clinical study on SBR759.
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Secondary Objective: To evaluate sustained efficacy in patients who have completed a clinical study on SBR759.
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Secondary ID(s)
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2009-011007-23-IT
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CSBR759A 2305
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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 Posted:
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Date Completed:
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URL:
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