HyperphosphatemiaPhase 2/3OsvaRenNEWNCT02027662
Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules
A Phase 2/3 study testing Osvaren Granules and Osvaren film-coated tablets in people with Hyperphosphatemia and Chronic Kidney Disease, run by Fresenius Medical Care Deutschland GmbH at 11 sites in Germany.
Trial summary
Phosphate binders are crucial to the control of elevated phosphate levels in patients with chronic kidney disease. With the new formulation of granules the pill burden of patients is sought to be reduced. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperphosphatemia, Chronic Kidney Disease
- What is being tested?
- Osvaren Granules and Osvaren film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 11 sitesGermany
- Study dates
- Jan 2014to Jun 2015
- Phase
- Phase 2/3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent form is obtained prior to starting the screening visit
- Male and female patients 18-80 years of age with dialysis dependent renal failure (CKD 5D)
- Patients have been on 3x/week in-centre renal replacement therapy for at least 2 months on either low-flux or high-flux HD or OL-
- /HDF
- Prescribed haemodialysis session duration is ≥ 4 hours
- spKt/V ≥ 1.20 according to last in-centre measurement prior the study enrolment
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- Patients have been on OsvaRen® tablets for at least 12 weeks as sole phosphate binder and the titration phase has been completed according to physician´s discretion
- Patients are able to take the study medication as prescribed particularly OsvaRen® stickpacks
- Patients are willing to stop any calcium, magnesium or vitamin D containing supplements
- Patients are willing to maintain their typical diet with regards to phosphate uptake for the time of the study
- Patients are willing to comply with the study protocol
Who cannot join
- Pregnant women (by blood ß-hCG pregnancy test) or women breast-feeding or unwilling to use contraceptive measures during the entire course of the study or
- Patients with a life expectancy shorter than the planned duration of the study or
- Patients with any acute or chronic severe disease potentially interfering with study outcomes or
- Patients with PTH levels > 800 ng/l or
- Patients who participated in an interventional clinical study during the preceding 30 days or
- Patients suffering from any other, not mentioned condition which could interfere with the patient's ability to comply with the study or
- Patients who previously participated in the same study are excluded from the study
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
RWTH University Hospital, Dpt for Nephrology
Aachen, North Rhine-Westphalia, 52074
Nephro-Studien GbR am Klinikum Erfurt
Erfurt
Dialysezentrum
Flensburg, 24939
Georg-Haas-Dialysezentrum der PHV
Giessen, Hesse, 35392
Nephrocare Hamburg-Barmbek GmbH
Hamburg, 22297
Dialysezentrum
Hanover
Dialysezentrum
Kiel, 24106
Dialysezentrum
Magdeburg
Dialysezentrum
Minden
Dialysezentrum
Solingen
Dialysezentrum
Velbert
About this study
Official title: Study to Investigate Efficacy and Safety Equivalence of OsvaRen® Tablets and OsvaRen® Granules
Phosphate binders are crucial to the control of elevated phosphate levels in patients with chronic kidney disease. With the new formulation of granules the pill burden of patients is sought to be reduced.
This study is about efficacy and safety of the new drug formulation and compares it to the "old" formulation which are film-coated tablets.
Read the detailed description
The study is aimed at demonstrating the therapeutic equivalence of both products, i.e. granules versus tablets.
Secondary objectives are: Comparing both preparations with regard to the number of patients reaching serum phosphate levels < 1.76 mmol/L and the difference in serum phosphate levels between the first and last visit under each treatment. Furthermore, it is the aim of this study to evaluate the safety profile of OsvaRen® granules in comparison to OsvaRen® tablets. Especially serum calcium, magnesium, and PTH are of interest.
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Being tested
- Osvaren Granules, Osvaren film-coated tablets
- Medical subject headings
- Hyperphosphatemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osvaren GranulesDrug
Osvaren film-coated tabletsDrug
| Study group | Role | What they receive |
|---|---|---|
| Osvaren Granules | Experimental | Osvaren Granules Receives: Drug: Osvaren Granules |
| Osvaren film-coated tablets | Active comparator | Osvaren film-coated tablets Receives: Drug: Osvaren film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of phosphate control by granules versus tablets. Serum phosphate levels will be measured for the primary outcome.
Measured: After 4 weeks of treatment time
Secondary outcomes (1)
Number of patients reaching serum phosphate levels < 1.76 mmol/L. this study to evaluate the safety profile of OsvaRen® granules. in comparison to OsvaRen® tablets. Especially serum calcium, magnesium, and PTH are of interest.
Measured: Between the first and last visit under each treatment i.e. 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionJun 2015
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 HyperphosphatemiaStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jürgen Floege, MD, Principal investigator, University Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027662
- Sponsor's protocol ID
- RP-OSV-02-D
- Acronym
- OsvaRenNEW
- Status last verified
- Jun 2015
- First submitted
- 20 Dec 2013
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PubMed 40576086
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate Efficacy and Safety Equivalence of OsvaRen® Tablets and OsvaRen® Granules
- ClinicalTrials.gov ID
- NCT02027662
- Acronym / sponsor ID
- OsvaRenNEW / RP-OSV-02-D
- Conditions
- Hyperphosphatemia, Chronic Kidney Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Jan 2014 (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.
Phosphate binders are crucial to the control of elevated phosphate levels in patients with chronic kidney disease. With the new formulation of granules the pill burden of patients is sought to be reduced.
This study is about efficacy and safety of the new drug formulation and compares it to the "old" formulation which are film-coated tablets.
Detailed description
The study is aimed at demonstrating the therapeutic equivalence of both products, i.e. granules versus tablets.
Secondary objectives are: Comparing both preparations with regard to the number of patients reaching serum phosphate levels < 1.76 mmol/L and the difference in serum phosphate levels between the first and last visit under each treatment. Furthermore, it is the aim of this study to evaluate the safety profile of OsvaRen® granules in comparison to OsvaRen® tablets. Especially serum calcium, magnesium, and PTH are of interest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osvaren Granules | Experimental | Drug: Osvaren GranulesOsvaren Granules |
| Osvaren film-coated tablets | Active comparator | Drug: Osvaren film-coated tabletsOsvaren film-coated tablets |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent form is obtained prior to starting the screening visit
- Male and female patients 18-80 years of age with dialysis dependent renal failure (CKD 5D)
- Patients have been on 3x/week in-centre renal replacement therapy for at least 2 months on either low-flux or high-flux HD or OL-
- /HDF
- Prescribed haemodialysis session duration is ≥ 4 hours
Key exclusion criteria (7 listed)
- Pregnant women (by blood ß-hCG pregnancy test) or women breast-feeding or unwilling to use contraceptive measures during the entire course of the study or
- Patients with a life expectancy shorter than the planned duration of the study or
- Patients with any acute or chronic severe disease potentially interfering with study outcomes or
- Patients with PTH levels > 800 ng/l or
- Patients who participated in an interventional clinical study during the preceding 30 days or
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osvaren Granules | Drug | Osvaren Granules |
| Osvaren film-coated tablets | Drug | Osvaren film-coated tablets |
Primary outcome
Non-inferiority of phosphate control by granules versus tablets. Serum phosphate levels will be measured for the primary outcome.
Time frame: After 4 weeks of treatment time
1 secondary outcome
Number of patients reaching serum phosphate levels < 1.76 mmol/L. this study to evaluate the safety profile of OsvaRen® granules. in comparison to OsvaRen® tablets. Especially serum calcium, magnesium, and PTH are of interest.
Time frame: Between the first and last visit under each treatment i.e. 4 weeks
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 10 Jun 2015.
- Derived from this study: PubMed 40576086Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
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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.
Jürgen Floege, MD principal investigator
University Aachen
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Osvaren Granules and Osvaren film-coated tablets in people with Hyperphosphatemia and Chronic Kidney Disease, run by Fresenius Medical Care Deutschland GmbH at 11 sites in Germany.
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 11 inclusion and 7 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 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Non-inferiority of phosphate control by granules versus tablets. Serum phosphate levels will be measured for the primary outcome. (time frame: After 4 weeks of treatment time). 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 NCT02027662, 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 10 Jun 2015.