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Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules (OsvaRenNEW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02027662
Recruitment Status : Completed
First Posted : January 6, 2014
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH

Brief 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.


Condition or disease Intervention/treatment Phase
Hyperphosphatemia Chronic Kidney Disease Drug: Osvaren Granules Drug: Osvaren film-coated tablets Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Investigate Efficacy and Safety Equivalence of OsvaRen® Tablets and OsvaRen® Granules
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Osvaren Granules
Osvaren Granules
Drug: Osvaren Granules
Active Comparator: Osvaren film-coated tablets
Osvaren film-coated tablets
Drug: Osvaren film-coated tablets



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027662


Locations
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Germany
Georg-Haas-Dialysezentrum der PHV
Giessen, Hessen, Germany, 35392
RWTH University Hospital, Dpt for Nephrology
Aachen, NRW, Germany, 52074
Nephro-Studien GbR am Klinikum Erfurt
Erfurt, Germany
Dialysezentrum
Flensburg, Germany, 24939
Nephrocare Hamburg-Barmbek GmbH
Hamburg, Germany, 22297
Dialysezentrum
Hannover, Germany
Dialysezentrum
Kiel, Germany, 24106
Dialysezentrum
Magdeburg, Germany
Dialysezentrum
Minden, Germany
Dialysezentrum
Solingen, Germany
Dialysezentrum
Velbert, Germany
Sponsors and Collaborators
Fresenius Medical Care Deutschland GmbH
Investigators
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Principal Investigator: Jürgen Floege, MD University Aachen

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Responsible Party: Fresenius Medical Care Deutschland GmbH
ClinicalTrials.gov Identifier: NCT02027662     History of Changes
Other Study ID Numbers: RP-OSV-02-D
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases