Status:

COMPLETED

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

Lead Sponsor:

Fresenius Medical Care Deutschland GmbH

Collaborating Sponsors:

Siro Clinpharm Germany GmbH

Conditions:

Hyperphosphataemia

ESRD

Eligibility:

All Genders

18+ years

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, an...

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 s...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

October 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 1 2014

Estimated Enrollment :

324 Patients enrolled

Trial Details

Trial ID

NCT01424787

Start Date

October 1 2011

End Date

March 1 2014

Last Update

March 6 2015

Active Locations (24)

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Page 1 of 6 (24 locations)

1

Regionshospitalet Holstebro

Holstebro, Holstebro, Denmark, 7500

2

Nykøbing Falster Sygehus

Nykøbing Mors, Nykobing, Denmark, 4800

3

Roskilde Sygehus

Roskilde, Roskilde, Denmark, 4000

4

Viborg Sygehus

Viborg, Viborg, Denmark, 8800