Clinical Trial: Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)

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 Summary: 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.
Sponsor: Fresenius Medical Care Deutschland GmbH

Current Primary Outcome: Serum phosphorus [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Adverse drug reactions [ Time Frame: 12 months ]

Original Secondary Outcome: Same as current

Information By: Fresenius Medical Care Deutschland GmbH

Dates:
Date Received: August 26, 2011
Date Started: October 2011
Date Completion:
Last Updated: March 5, 2015
Last Verified: March 2015