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

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.

Study Overview

• Status: Completed
• Conditions: ESRD; Hyperphosphataemia

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
• Enrollment (Actual): 324

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Dialysis patients (HD, HDF, or PD) being treated with OsvaRen for hyperphosphataemia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
OsvaRen treatment; Dialysis patients on OsvaRen treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum phosphorus	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse drug reactions	12 months

Collaborators and Investigators

• Sponsor: Fresenius Medical Care Deutschland GmbH
• Collaborators: Siro Clinpharm Germany GmbH
• Investigators: Principal Investigator: Helmut Geiger, MD, Prof, University Hospital, Frankfurt, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: August 26, 2011
• First Submitted That Met QC Criteria: August 26, 2011
• First Posted (Estimate): August 29, 2011

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: RP-OSV-01-EU