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CompletedNCT02027662OsvaRenNEWUpdated Jun 10, 2015

Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules

A Phase 2/3 interventional study of Osvaren Granules and Osvaren film-coated tablets in Hyperphosphatemia and Chronic Kidney Disease, sponsored by Fresenius Medical Care Deutschland GmbH. Completed at 11 sites in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-06-10.

Sponsored by Fresenius Medical Care Deutschland GmbH · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Hyperphosphatemia
  • Chronic Kidney Disease
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 61 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Fresenius Medical Care Deutschland GmbH is the lead sponsor of 36 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion criteria

  • 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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Osvaren Granules

    Osvaren Granules

    Drug: Osvaren Granules

  • Active comparator
    Osvaren film-coated tablets

    Osvaren film-coated tablets

    Drug: Osvaren film-coated tablets

Interventions

  • DrugOsvaren Granules
  • DrugOsvaren film-coated tablets
06

What researchers measure

Primary outcomes

  1. 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

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.

    Time frame: Between the first and last visit under each treatment i.e. 4 weeks

07

Study locations

11 sites
  • Georg-Haas-Dialysezentrum der PHV
    Giessen, Hessen 35392, Germany
  • RWTH University Hospital, Dpt for Nephrology
    Aachen, NRW 52074, Germany
  • Nephro-Studien GbR am Klinikum Erfurt
    Erfurt, Germany
  • Dialysezentrum
    Flensburg, 24939, Germany
  • Nephrocare Hamburg-Barmbek GmbH
    Hamburg, 22297, Germany
  • Dialysezentrum
    Hannover, Germany
  • Dialysezentrum
    Kiel, 24106, Germany
  • Dialysezentrum
    Magdeburg, Germany
  • Dialysezentrum
    Minden, Germany
  • Dialysezentrum
    Solingen, Germany
  • Dialysezentrum
    Velbert, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02027662
Lead sponsor
Fresenius Medical Care Deutschland GmbH
Responsible party
Sponsor
First posted
Jan 6, 2014
Start date
Jan 2014
Primary completion
Apr 2015
Completion
Jun 2015
Last update
Jun 10, 2015

Study contacts

Jürgen Floege, MD
principal investigator · University Aachen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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