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

Primary Purpose

Hyperphosphatemia, Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Osvaren Granules
Osvaren film-coated tablets
Sponsored by
Fresenius Medical Care Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Georg-Haas-Dialysezentrum der PHV
  • RWTH University Hospital, Dpt for Nephrology
  • Nephro-Studien GbR am Klinikum Erfurt
  • Dialysezentrum
  • Nephrocare Hamburg-Barmbek GmbH
  • Dialysezentrum
  • Dialysezentrum
  • Dialysezentrum
  • Dialysezentrum
  • Dialysezentrum
  • Dialysezentrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Osvaren Granules

Osvaren film-coated tablets

Arm Description

Osvaren Granules

Osvaren film-coated tablets

Outcomes

Primary Outcome Measures

Non-inferiority of phosphate control by granules versus tablets. Serum phosphate levels will be measured for the primary outcome.

Secondary Outcome Measures

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.

Full Information

First Posted
December 20, 2013
Last Updated
June 9, 2015
Sponsor
Fresenius Medical Care Deutschland GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02027662
Brief Title
Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules
Acronym
OsvaRenNEW
Official Title
Study to Investigate Efficacy and Safety Equivalence of OsvaRen® Tablets and OsvaRen® Granules
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Medical Care Deutschland GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osvaren Granules
Arm Type
Experimental
Arm Description
Osvaren Granules
Arm Title
Osvaren film-coated tablets
Arm Type
Active Comparator
Arm Description
Osvaren film-coated tablets
Intervention Type
Drug
Intervention Name(s)
Osvaren Granules
Intervention Type
Drug
Intervention Name(s)
Osvaren film-coated tablets
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jürgen Floege, MD
Organizational Affiliation
University Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georg-Haas-Dialysezentrum der PHV
City
Giessen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
RWTH University Hospital, Dpt for Nephrology
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany
Facility Name
Nephro-Studien GbR am Klinikum Erfurt
City
Erfurt
Country
Germany
Facility Name
Dialysezentrum
City
Flensburg
ZIP/Postal Code
24939
Country
Germany
Facility Name
Nephrocare Hamburg-Barmbek GmbH
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
Facility Name
Dialysezentrum
City
Hannover
Country
Germany
Facility Name
Dialysezentrum
City
Kiel
ZIP/Postal Code
24106
Country
Germany
Facility Name
Dialysezentrum
City
Magdeburg
Country
Germany
Facility Name
Dialysezentrum
City
Minden
Country
Germany
Facility Name
Dialysezentrum
City
Solingen
Country
Germany
Facility Name
Dialysezentrum
City
Velbert
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules

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