Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006364

Trial Description

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Title

Study to Investigate Efficacy and Safety Equivalence of OsvaRen® Tablets and OsvaRen® Granules

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Trial Acronym

OsvaRen-NEW

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00006364
  •   2014/09/08
  •   2013/12/20
  •   no
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Secondary IDs

  •   NCT02027662  (ClinicalTrials.gov)
  •   RP-OSV-02-D  (Fresenius Medical Care Deutschland GmbH)
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Health Condition or Problem studied

  •   Hyperphosphatemia
  •   Chronic Kidney Disease
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Interventions/Observational Groups

  •   Drug: Osvaren Granules
  •   Drug: Osvaren film-coated tablets
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Treatment
  •   Factorial
  •   II-III
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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

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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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2014/01/31
  •   60
  •   Multicenter trial
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Fresenius Medical Care Deutschland GmbH
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    • University Aachen
    • Jürgen Floege, MD 
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    • Frank M Laukhuf, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   60
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.