Clinical trial NCT01424787: Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)
Official title: Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperphosphataemia
ESRD
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: Siro Clinpharm Germany GmbH
First posted: 2011-08-29
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dialysis patients (HD, HDF, or PD) being treated with OsvaRen for hyperphosphataemia

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Prior participation in this observational study
* Use of OsvaRen® for purposes other than those indicated in the Summary of Product Characteristics (SmPC) / package leaflet

Primary outcomes:
measure: Serum phosphorus
timeFrame: 12 months
Secondary outcomes:
measure: Adverse drug reactions
timeFrame: 12 months
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Regionshospitalet Holstebro
city: Nykobing
country: Denmark
facility: Nykøbing Falster Sygehus
city: Roskilde
country: Denmark
facility: Roskilde Sygehus
city: Viborg
country: Denmark
facility: Viborg Sygehus
city: Aachen
country: Germany
facility: Dialysezentrum
city: Alsfeld
country: Germany
facility: Dialysezentrum
city: Augsburg
country: Germany
facility: Dialyszentrum/Gemeinschaftspraxis
city: Cottbus
country: Germany
facility: Nephrologicum Lausitz
city: Dusseldorf
country: Germany
facility: Studienzentrum Karlstraße
city: Essen
country: Germany
facility: Dialyse am Lichtbogen
city: Flensburg
country: Germany
facility: Diakonissenkrankenhaus Flensburg
city: Goslar
country: Germany
facility: PHV-Dialysezentrum Goslar
city: Hannover
country: Germany
facility: Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
city: Hoyerswerda
country: Germany
facility: Gemeinschaftspraxis Nephrologie/Dialyse
city: Kaiserslautern
country: Germany
facility: Internistische Schwerpunktpraxis Gastroenterologie / Nephrologie
city: Kiel
country: Germany
facility: PHV Dialysezentrum Kiel
city: Magdeburg
country: Germany
facility: Gemeinschaftspraxis Dialyse
city: Pforzheim
country: Germany
facility: Dialysezentrum Pforzheim
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Ourense
country: Spain
facility: Complejo Hospitalario de Ourense
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Londonderry
country: United Kingdom
facility: Western Health and Social Care Trust
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
Study officials:
affiliation: University Hospital, Frankfurt, Germany
name: Helmut Geiger, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.