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

ESRD Clinical Trial

— Steering  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424787
• Other study ID #: RP-OSV-01-EU
• Status: Completed
• Phase: N/A
• First received: August 26, 2011
• Last updated: March 5, 2015
• Start date: October 2011
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyGermany: Federal Institute for Drugs and Medical DevicesSpain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• ESRD
• Hyperphosphataemia
• Hyperphosphatemia

Locations

Country	Name	City	State
Denmark	Regionshospitalet Holstebro	Holstebro
Denmark	Nykøbing Falster Sygehus	Nykobing
Denmark	Roskilde Sygehus	Roskilde
Denmark	Viborg Sygehus	Viborg
Germany	Dialysezentrum	Aachen
Germany	Dialysezentrum	Alsfeld
Germany	Dialyszentrum/Gemeinschaftspraxis	Augsburg
Germany	Nephrologicum Lausitz	Cottbus
Germany	Studienzentrum Karlstraße	Dusseldorf
Germany	Dialyse am Lichtbogen	Essen
Germany	Diakonissenkrankenhaus Flensburg	Flensburg
Germany	PHV-Dialysezentrum Goslar	Goslar
Germany	Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen	Hannover
Germany	Gemeinschaftspraxis Nephrologie/Dialyse	Hoyerswerda
Germany	Internistische Schwerpunktpraxis Gastroenterologie / Nephrologie	Kaiserslautern
Germany	PHV Dialysezentrum Kiel	Kiel
Germany	Gemeinschaftspraxis Dialyse	Magdeburg
Germany	Dialysezentrum Pforzheim	Pforzheim
Spain	Hospital Infanta Leonor	Madrid
Spain	Complejo Hospitalario de Ourense	Ourense
Spain	Hospital Universitario Marqués de Valdecilla	Santander
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Western Health and Social Care Trust	Londonderry
United Kingdom	Royal Shrewsbury Hospital	Shrewsbury

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH	Siro Clinpharm Germany GmbH

Countries where clinical trial is conducted

Denmark,  Germany,  Spain,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum phosphorus		12 months	No
Secondary	Adverse drug reactions		12 months	Yes