Phosphate Diet Strategies to Lower Blood Phosphate in Dialysis Patients
NCT07180069
Chronic Kidney Disease 5D, Diet Therapy
Najaf, Iraq
View Trial DetailsNCT Number: NCT01424787
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.
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Notify Me18 year and older
All sexes
Observational
Regionshospitalet Holstebro, Holstebro, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 months
Time frame: 12 months
Fresenius Medical Care Deutschland GmbH
Industry
Acronym: Steering
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