Hyperphosphataemia in end stage renal failure patients on extracorporeal renal replacement therapy
Conditions
Interventions
Product Name: OsvaRen Granules
Pharmaceutical Form: Granules
INN or Proposed INN: Calcium acetate
CAS Number: 62-54-4
Other descriptive name: CALCIUM ACETATE
Concentration unit: mg milligram(s)
Concen
Sponsors
Fresenius Medical Care Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 a) test drug (OsvaRen granules) and b) comparator drug (OsvaRen tablets) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of patients with serum phosphate levels <1.76 mmol/l - Difference in serum phosphate levels between the first and last visit for each treatment ;Timepoint(s) of evaluation of this end point: Comparing quoted end points after 4 weeks of treatment with a) test drug (OsvaRen granules) and b) comparator drug (OsvaRen tablets) | — |
Countries
Germany
Contacts
Public ContactR&D, Clinical Research
Fresenius Medical Care Deutschland GmbH
Outcome results
None listed