Testing whether the new drug formulation of OsvaRen granules is as efficacious and as safe as Osvaren tablets.

Conditions: Hyperphosphataemia in end stage renal failure patients on extracorporeal renal replacement therapy
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2012-004178-24-DE

Lead Sponsor: Fresenius Medical Care Deutschland GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstrating the therapeutic equivalence of OsvaRen granules versus tablets.;Secondary Objective: Comparing OsvaRen® granules and OsvaRen® tablets with regard to the number of patients reaching serum phosphate levels < 1.76 mmol/l and the difference in serum phosphate levels between the first and last visit under each treatment. Furthermore, it is the aim of this study to evaluate the safety profile of OsvaRen® granules in comparison to OsvaRen® tablets. Especially serum calcium, magnesium, and parathyroid hormone (PTH) are of interest.;Primary end point(s): Serum phosphate levels;Timepoint(s) of evaluation of this end point: Comparing serum phosphate levels after 4 weeks of treatment with <br>a) test drug (OsvaRen granules)<br>and<br>b) comparator drug (OsvaRen tablets)<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Number of patients with serum phosphate levels <1.76 mmol/l<br>- Difference in serum phosphate levels between the first and last visit for each treatment<br>;Timepoint(s) of evaluation of this end point: Comparing quoted end points after 4 weeks of treatment with <br>a) test drug (OsvaRen granules)<br>and<br>b) comparator drug (OsvaRen tablets)