None listed
Conditions
Interventions
Product Name: balance Solution (low sodium peritoneal dialysis solution
Pharmaceutical Form: Solution for peritoneal dialysis
Sponsors
Fresenius Medical Care Deutschland GmbH.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult CAPD patiens >= 18 years Patients with at least 3 months experience on CAPD prior to inclusion Patients treated with registered balance solution for at least 4 weeks prior to inclusion Patients receiving at least one anti-hypertensive drug (incl. diuretics) or showing a systolic office blood pressure of >=130 mmHg, defined by the mean of two measurements in seated position with 5 minutes in between each measurement Signed and dated informed consent by study patient and investigator/authorised physician Are the trial subjects under 18? 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: Patients with known medical history of recurrent severe hyponatremia <130 mmol/L Peritonitis treatment <=4 weeks preceding inclusion Malignant disease without remission women of childbearing potential without effective means of contraception, pregnancy, lactation period Active HBV or HCV infection HIV positive Participation in another interventional clinical study during the preceding 30 days Previous participation in the same study Planned travel activities outiside the participating countries (Austria, Germany, Poland and the Netherlands) if the study medication cannot be transported by the patient himself
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of the investigational CAPD solution balance low sodium when compared to the registered CAPD Solution balance as an active control, in double blinded testing ;Secondary Objective: Safety on the investigational CAPD solution balance low sodium when compared to the registered CAPD Solution balance as an active control, in double blinded testing Cardiovascular effects of balance low sodium solution as defined by changes on blood pressure, changes on the number or dosage of anti-hypertensive drugs as well as changes in serum markers related to the cardiovascular system Effects of balance low sodium solutin on sodium balance as defined by daily dietetic sodium uptake and daily sodium excretion Quality-of-life;Primary end point(s): Total weekly Kt/V urea | — |
Countries
Austria
Outcome results
None listed