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| Name | Class |
|---|---|
| Siro Clinpharm Germany GmbH | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OsvaRen treatment | Dialysis patients on OsvaRen treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Serum phosphorus | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse drug reactions | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Dialysis patients (HD, HDF, or PD) being treated with OsvaRen for hyperphosphataemia
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| Name | Affiliation | Role |
|---|---|---|
| Helmut Geiger, MD, Prof | University Hospital, Frankfurt, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regionshospitalet Holstebro | Holstebro | Holstebro | 7500 | Denmark | ||
| Nykøbing Falster Sygehus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20530499 | Background | de Francisco AL, Leidig M, Covic AC, Ketteler M, Benedyk-Lorens E, Mircescu GM, Scholz C, Ponce P, Passlick-Deetjen J. Evaluation of calcium acetate/magnesium carbonate as a phosphate binder compared with sevelamer hydrochloride in haemodialysis patients: a controlled randomized study (CALMAG study) assessing efficacy and tolerability. Nephrol Dial Transplant. 2010 Nov;25(11):3707-17. doi: 10.1093/ndt/gfq292. Epub 2010 Jun 7. |
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| Nykøbing Mors |
| Nykobing |
| 4800 |
| Denmark |
| Roskilde Sygehus | Roskilde | Roskilde | 4000 | Denmark |
| Viborg Sygehus | Viborg | Viborg | 8800 | Denmark |
| Dialysezentrum | Aachen | 52066 | Germany |
| Dialysezentrum | Alsfeld | 36304 | Germany |
| Dialyszentrum/Gemeinschaftspraxis | Augsburg | 86157 | Germany |
| Nephrologicum Lausitz | Cottbus | 03046 | Germany |
| Studienzentrum Karlstraße | Düsseldorf | 40210 | Germany |
| Dialyse am Lichtbogen | Essen | 45141 | Germany |
| Diakonissenkrankenhaus Flensburg | Flensburg | 24939 | Germany |
| PHV-Dialysezentrum Goslar | Goslar | 38642 | Germany |
| Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen | Hanover | 30625 | Germany |
| Gemeinschaftspraxis Nephrologie/Dialyse | Hoyerswerda | 02977 | Germany |
| Internistische Schwerpunktpraxis Gastroenterologie / Nephrologie | Kaiserslautern | 67655 | Germany |
| PHV Dialysezentrum Kiel | Kiel | 24106 | Germany |
| Gemeinschaftspraxis Dialyse | Magdeburg | 39124 | Germany |
| Dialysezentrum Pforzheim | Pforzheim | 75179 | Germany |
| Hospital Infanta Leonor | Madrid | 28032 | Spain |
| Complejo Hospitalario de Ourense | Ourense | 32005 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | 39008 | Spain |
| Birmingham Heartlands Hospital | Birmingham | B95SS | United Kingdom |
| Western Health and Social Care Trust | Londonderry | BT476SB | United Kingdom |
| Royal Shrewsbury Hospital | Shrewsbury | SY3 8XQ | United Kingdom |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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