A facilitated access open-label, non-randomized, multicenter,long-term safety and efficacy study in ChronicKidney Disease patients treated with SBR759 who havecompleted previous SBR759 studies

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate long term safety data in patients who have completed a clinical study on SBR759<br><br>(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);Secondary Objective: To evaluate sustained efficacy in patients who have completed a clinical study on SBR759.;Primary end point(s): To evaluate long term safety data in patients who have completed a clinical study on SBR759.

Secondary Outcome Measures

Name	Time	Method

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