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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01424787
Recruitment Status : Completed
First Posted : August 29, 2011
Last Update Posted : March 6, 2015
Siro Clinpharm Germany GmbH
Information provided by (Responsible Party):
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.

Condition or disease
Hyperphosphataemia ESRD

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.

Study Type : Observational
Actual Enrollment : 324 participants
Observational Model: Cohort
Official Title: Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)
Study Start Date : October 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

OsvaRen treatment
Dialysis patients on OsvaRen treatment

Primary Outcome Measures :
  1. Serum phosphorus [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Adverse drug reactions [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dialysis patients (HD, HDF, or PD) being treated with OsvaRen for hyperphosphataemia

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01424787

Regionshospitalet Holstebro
Holstebro, Denmark, 7500
Nykøbing Falster Sygehus
Nykobing, Denmark, 4800
Roskilde Sygehus
Roskilde, Denmark, 4000
Viborg Sygehus
Viborg, Denmark, 8800
Aachen, Germany, 52066
Alsfeld, Germany, 36304
Augsburg, Germany, 86157
Nephrologicum Lausitz
Cottbus, Germany, 03046
Studienzentrum Karlstraße
Dusseldorf, Germany, 40210
Dialyse am Lichtbogen
Essen, Germany, 45141
Diakonissenkrankenhaus Flensburg
Flensburg, Germany, 24939
PHV-Dialysezentrum Goslar
Goslar, Germany, 38642
Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
Hannover, Germany, 30625
Gemeinschaftspraxis Nephrologie/Dialyse
Hoyerswerda, Germany, 02977
Internistische Schwerpunktpraxis Gastroenterologie / Nephrologie
Kaiserslautern, Germany, 67655
PHV Dialysezentrum Kiel
Kiel, Germany, 24106
Gemeinschaftspraxis Dialyse
Magdeburg, Germany, 39124
Dialysezentrum Pforzheim
Pforzheim, Germany, 75179
Hospital Infanta Leonor
Madrid, Spain, 28032
Complejo Hospitalario de Ourense
Ourense, Spain, 32005
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B95SS
Western Health and Social Care Trust
Londonderry, United Kingdom, BT476SB
Royal Shrewsbury Hospital
Shrewsbury, United Kingdom, SY3 8XQ
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Siro Clinpharm Germany GmbH
Principal Investigator: Helmut Geiger, MD, Prof University Hospital, Frankfurt, Germany