NCT01424787

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
4 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

2.4 years

First QC Date

August 26, 2011

Last Update Submit

March 5, 2015

Conditions

HyperphosphataemiaESRD

Outcome Measures

Primary Outcomes (1)

  • Serum phosphorus

    12 months

Secondary Outcomes (1)

  • Adverse drug reactions

    12 months

Study Arms (1)

OsvaRen treatment

Dialysis patients on OsvaRen treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age ≥ 18 years
  • Signed Informed Consent
  • Patient on maintenance haemodialysis, online haemodiafiltration, or peritoneal dialysis at the time of OsvaRen® prescription

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Regionshospitalet Holstebro

Holstebro, Holstebro, 7500, Denmark

Location

Nykøbing Falster Sygehus

Nykøbing Mors, Nykobing, 4800, Denmark

Location

Roskilde Sygehus

Roskilde, Roskilde, 4000, Denmark

Location

Viborg Sygehus

Viborg, Viborg, 8800, Denmark

Location

Dialysezentrum

Aachen, 52066, Germany

Location

Dialysezentrum

Alsfeld, 36304, Germany

Location

Dialyszentrum/Gemeinschaftspraxis

Augsburg, 86157, Germany

Location

Nephrologicum Lausitz

Cottbus, 03046, Germany

Location

Studienzentrum Karlstraße

Düsseldorf, 40210, Germany

Location

Dialyse am Lichtbogen

Essen, 45141, Germany

Location

Diakonissenkrankenhaus Flensburg

Flensburg, 24939, Germany

Location

PHV-Dialysezentrum Goslar

Goslar, 38642, Germany

Location

Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen

Hanover, 30625, Germany

Location

Gemeinschaftspraxis Nephrologie/Dialyse

Hoyerswerda, 02977, Germany

Location

Internistische Schwerpunktpraxis Gastroenterologie / Nephrologie

Kaiserslautern, 67655, Germany

Location

PHV Dialysezentrum Kiel

Kiel, 24106, Germany

Location

Gemeinschaftspraxis Dialyse

Magdeburg, 39124, Germany

Location

Dialysezentrum Pforzheim

Pforzheim, 75179, Germany

Location

Hospital Infanta Leonor

Madrid, 28032, Spain

Location

Complejo Hospitalario de Ourense

Ourense, 32005, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Birmingham Heartlands Hospital

Birmingham, B95SS, United Kingdom

Location

Western Health and Social Care Trust

Londonderry, BT476SB, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, SY3 8XQ, United Kingdom

Location

Related 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.

    PMID: 20530499BACKGROUND

MeSH Terms

Conditions

HyperphosphatemiaKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Helmut Geiger, MD, Prof

    University Hospital, Frankfurt, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2011

First Posted

August 29, 2011

Study Start

October 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

DE(14)GB(3)DK(4)ES(3)