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 - ND

• Register: EUCTR
• Last refreshed on: 24 April 2012
• Main ID: EUCTR2009-011007-23-IT
• Date of registration: 03/07/2009
• Prospective Registration: Yes
• Primary sponsor: NOVARTIS FARMA
• Public title: 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 - ND
• Scientific title: 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 - ND
• Date of first enrolment: 21/07/2009
• Target sample size: 500
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011007-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Belgium, Finland, France, Italy, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
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:
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 the skin), 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

Health Condition(s) or Problem(s) studied

Hyperphosphataemia in patients with Chronic Kidney Disease (CKD) on haemodialysis
MedDRA version: 12.0 Level: LLT Classification code 10020711 Term: Hyperphosphataemia

Intervention(s)

Product Code: SBR759
Pharmaceutical Form: Powder for oral solution
Current Sponsor code: CSBR759
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1000-

Primary Outcome(s)

Main Objective: Primary Objectives: To evaluate long term safety data 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 Objective: Key secondary objectives: To evaluate sustained efficacy in patients who have completed a clinical study on SBR759.

Secondary ID(s)

CSBR759A2305