HyperphosphataemiaSteeringNCT01424787
Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)
An observational study of Hyperphosphataemia and ESRD, run by Fresenius Medical Care Deutschland GmbH at 24 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperphosphataemia, ESRD
- How many people
- 324 participants
- Where
- 24 sitesin 4 countries
- Study dates
- Oct 2011to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dialysis patients (HD, HDF, or PD) being treated with OsvaRen for hyperphosphataemia
Who may be able to join
- 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
Who cannot join
- Prior participation in this observational study
- Use of OsvaRen® for purposes other than those indicated in the Summary of Product Characteristics (SmPC) / package leaflet
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
Germany14 sites
Dialysezentrum
Aachen, 52066
Dialysezentrum
Alsfeld, 36304
Dialyszentrum/Gemeinschaftspraxis
Augsburg, 86157
Nephrologicum Lausitz
Cottbus, 03046
Studienzentrum Karlstraße
Düsseldorf, 40210
Dialyse am Lichtbogen
Essen, 45141
Diakonissenkrankenhaus Flensburg
Flensburg, 24939
PHV-Dialysezentrum Goslar
Goslar, 38642
Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
Hanover, 30625
Gemeinschaftspraxis Nephrologie/Dialyse
Hoyerswerda, 02977
Internistische Schwerpunktpraxis Gastroenterologie / Nephrologie
Kaiserslautern, 67655
PHV Dialysezentrum Kiel
Kiel, 24106
Gemeinschaftspraxis Dialyse
Magdeburg, 39124
Dialysezentrum Pforzheim
Pforzheim, 75179
Denmark4 sites
Regionshospitalet Holstebro
Holstebro, Holstebro, 7500
Nykøbing Falster Sygehus
Nykøbing Mors, Nykobing, 4800
Roskilde Sygehus
Roskilde, Roskilde, 4000
Viborg Sygehus
Viborg, Viborg, 8800
Spain3 sites
Hospital Infanta Leonor
Madrid, 28032
Complejo Hospitalario de Ourense
Ourense, 32005
Hospital Universitario Marqués de Valdecilla
Santander, 39008
United Kingdom3 sites
Birmingham Heartlands Hospital
Birmingham, B95SS
Western Health and Social Care Trust
Londonderry, BT476SB
Royal Shrewsbury Hospital
Shrewsbury, SY3 8XQ
About this study
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.
Read the 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.
- Conditions
- Hyperphosphataemia, ESRD
- Medical subject headings
- Hyperphosphatemia, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OsvaRen treatment | Dialysis patients on OsvaRen treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum phosphorus
Measured: 12 months
Secondary outcomes (1)
Adverse drug reactions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperphosphataemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Siro Clinpharm Germany GmbH
- Responsible party
- Sponsor
- Investigators
- Helmut Geiger, MD, Prof, Principal investigator, University Hospital, Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424787
- Sponsor's protocol ID
- RP-OSV-01-EU
- Acronym
- Steering
- Status last verified
- Mar 2015
- First submitted
- 26 Aug 2011
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20530499
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)
- ClinicalTrials.gov ID
- NCT01424787
- Acronym / sponsor ID
- Steering / RP-OSV-01-EU
- Conditions
- Hyperphosphataemia, ESRD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Siro Clinpharm Germany GmbH
- Study start
- Oct 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OsvaRen treatment | – | –Dialysis patients on OsvaRen treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dialysis patients (HD, HDF, or PD) being treated with OsvaRen for hyperphosphataemia
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Prior participation in this observational study
- Use of OsvaRen® for purposes other than those indicated in the Summary of Product Characteristics (SmPC) / package leaflet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum phosphorus
Time frame: 12 months
1 secondary outcome
Adverse drug reactions
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Background: PubMed 20530499de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut Geiger, MD, Prof principal investigator
University Hospital, Frankfurt, Germany
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperphosphataemia and ESRD, run by Fresenius Medical Care Deutschland GmbH at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Denmark, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum phosphorus (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01424787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.