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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Siro Clinpharm Germany GmbH
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier:
NCT01424787
First received: August 26, 2011
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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
Hyperphosphataemia
ESRD

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

Resource links provided by NLM:


Further study details as provided by Fresenius Medical Care Deutschland GmbH:

Primary Outcome Measures:
  • Serum phosphorus [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse drug reactions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 350
Study Start Date: October 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
OsvaRen treatment
Dialysis patients on OsvaRen treatment

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424787

Locations
Denmark
Regionshospitalet Holstebro
Holstebro, Denmark, 7500
Nykøbing Falster Sygehus
Nykobing, Denmark, 4800
Roskilde Sygehus
Roskilde, Denmark, 4000
Viborg Sygehus
Viborg, Denmark, 8800
Germany
Dialysezentrum
Aachen, Germany, 52066
Dialysezentrum
Alsfeld, Germany, 36304
Dialyszentrum/Gemeinschaftspraxis
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
Spain
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
Investigators
Principal Investigator: Helmut Geiger, MD, Prof University Hospital Frankfurt, Germany
  More Information

Publications:
Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT01424787     History of Changes
Other Study ID Numbers: RP-OSV-01-EU
Study First Received: August 26, 2011
Last Updated: January 29, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: National Health Service

Additional relevant MeSH terms:
Hyperphosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014