EUCTR2012-004178-24-DE
Active, Not Recruiting
N/A
Study to investigate the therapeutic equivalence of OsvaRen® tablets and OsvaRen® granules - OsvaRen NEW
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hyperphosphataemia in end stage renal failure patients on extracorporeal renal replacement therapy
- Sponsor
- Fresenius Medical Care Deutschland GmbH
- Status
- Active, Not Recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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