Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules

Chronic Kidney Disease Clinical Trial

— OsvaRenNEW  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027662
• Other study ID #: RP-OSV-02-D
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 20, 2013
• Last updated: June 9, 2015
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical 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.

This study is about efficacy and safety of the new drug formulation and compares it to the "old" formulation which are film-coated tablets.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Osvaren Granules

• Osvaren film-coated tablets

Locations

Country	Name	City	State
Germany	RWTH University Hospital, Dpt for Nephrology	Aachen	NRW
Germany	Nephro-Studien GbR am Klinikum Erfurt	Erfurt
Germany	Dialysezentrum	Flensburg
Germany	Georg-Haas-Dialysezentrum der PHV	Giessen	Hessen
Germany	Nephrocare Hamburg-Barmbek GmbH	Hamburg
Germany	Dialysezentrum	Hannover
Germany	Dialysezentrum	Kiel
Germany	Dialysezentrum	Magdeburg
Germany	Dialysezentrum	Minden
Germany	Dialysezentrum	Solingen
Germany	Dialysezentrum	Velbert

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority of phosphate control by granules versus tablets. Serum phosphate levels will be measured for the primary outcome.		After 4 weeks of treatment time	Yes
Secondary	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.		Between the first and last visit under each treatment i.e. 4 weeks	Yes