EUCTR2012-004178-24-DE进行中（未招募）不适用
Study to investigate the therapeutic equivalence of OsvaRen® tablets and OsvaRen® granules - OsvaRen NEW
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed written informed consent form is obtained prior to starting the screening visit
- •Male and female patients 18–75 years of age with dialysis dependent renal failure (CKD 5D)
- •Patients have been on 3x/week in-centre renal replacement therapy for at least 6 months on either high-flux HD or OL-/HDF
- •Prescribed haemodialysis session duration is = 4 hours
- •spKt/V = 1.20 according to last in-centre measurement prior the study enrolment
- •Patients have been on OsvaRen® tablets for at least 12 weeks as sole phosphate binder as sole phosphate binder and the titration phase has been completed according to physician´s discretion
- •Patients are able to take the study medication as prescribed particularly OsvaRen® granules (packed in stickpacks)
- •Patients are willing to stop any calcium, magnesium or vitamin D containing supplements
- •Patients are willing to maintain their typical diet with regards to phosphate uptake for the time of the study
- •Patients are willing to comply with the study protocol
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Pregnant women (by blood ß-hCG pregnancy test) or women breast-feeding or unwilling to use contraceptive measures during the entire course of the study or
- •Patients with a life expectancy shorter than the planned duration of the study or
- •Patients with any acute or chronic severe disease potentially interfering with study outcomes or
- •Patients with PTH levels > 800 ng/l or
- •Patients who participated in an interventional clinical study during the preceding 30 days or
- •Patients suffering from any other, not mentioned condition which could interfere with the patient’s ability to comply with the study or
- •Patients who previously participated in the same study
研究者
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