Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)
- Conditions
- ESRDHyperphosphataemia
- Registration Number
- NCT01424787
- Lead Sponsor
- Fresenius Medical Care Deutschland GmbH
- Brief Summary
The objective of this non-interventional study is to confirm that with standard OsvaRen® treatment it is possible to achieve in at least 60% of the patients the levels of phosphorus, total calcium, and iPTH seen in the CALMAG study also in the normal clinical practice.
- Detailed Description
Only a small fraction of haemodialysis patients meet the published NKF-KDOQI standards for calcium, phosphorus, calcium x phosphorus product and intact parathyroid hormone. One of the reasons is the still difficult and insufficient therapy with phosphate binders. Even though calcium containing phosphate binders have been proven to be effective, they are reported to lead in certain patients to hypercalcaemia. This observational study therefore not only evaluates the efficacy of the phosphate binder OsvaRen® (containing calcium acetate and magnesium carbonate) but also the frequency of untoward events in daily practice as well as to the state of hyper-/ hypoparathyroidism as represented by serum iPTH values and the practice patterns used to adjust to and to fully exploit the qualities of the different available phosphate binders. In addition, the compensatory actions of the physicians, such as adaptation of the dialysate calcium or the combination with non-calcium containing phosphate binders, are going to be monitored. In order to receive additional safety data in the context of daily practice, the frequency of untoward events related to the treatment will be documented and analysed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 324
- Age ≥ 18 years
- Signed Informed Consent
- Patient on maintenance haemodialysis, online haemodiafiltration, or peritoneal dialysis at the time of OsvaRen® prescription
- Patients being treated with OsvaRen® for up to 6 months at the day of inclusion
- Prior participation in this observational study
- Use of OsvaRen® for purposes other than those indicated in the Summary of Product Characteristics (SmPC) / package leaflet
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum phosphorus 12 months
- Secondary Outcome Measures
Name Time Method Adverse drug reactions 12 months
Trial Locations
- Locations (23)
Nykøbing Falster Sygehus
🇩🇰Nykobing, Denmark
Dialysezentrum
🇩🇪Alsfeld, Germany
Studienzentrum Karlstraße
🇩🇪Dusseldorf, Germany
Dialyszentrum/Gemeinschaftspraxis
🇩🇪Augsburg, Germany
Nephrologicum Lausitz
🇩🇪Cottbus, Germany
Diakonissenkrankenhaus Flensburg
🇩🇪Flensburg, Germany
Dialyse am Lichtbogen
🇩🇪Essen, Germany
PHV-Dialysezentrum Goslar
🇩🇪Goslar, Germany
Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
🇩🇪Hannover, Germany
Internistische Schwerpunktpraxis Gastroenterologie / Nephrologie
🇩🇪Kaiserslautern, Germany
Gemeinschaftspraxis Nephrologie/Dialyse
🇩🇪Hoyerswerda, Germany
PHV Dialysezentrum Kiel
🇩🇪Kiel, Germany
Gemeinschaftspraxis Dialyse
🇩🇪Magdeburg, Germany
Dialysezentrum Pforzheim
🇩🇪Pforzheim, Germany
Hospital Infanta Leonor
🇪🇸Madrid, Spain
Complejo Hospitalario de Ourense
🇪🇸Ourense, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Western Health and Social Care Trust
🇬🇧Londonderry, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, United Kingdom
Regionshospitalet Holstebro
🇩🇰Holstebro, Denmark
Roskilde Sygehus
🇩🇰Roskilde, Denmark
Viborg Sygehus
🇩🇰Viborg, Denmark