Clinical trial NCT02027662: Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules
Official title: Study to Investigate Efficacy and Safety Equivalence of OsvaRen® Tablets and OsvaRen® Granules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hyperphosphatemia
Chronic Kidney Disease
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2014-01-06
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Non-inferiority of phosphate control by granules versus tablets. Serum phosphate levels will be measured for the primary outcome.
timeFrame: After 4 weeks of treatment time
Secondary outcomes:
measure: 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.
timeFrame: Between the first and last visit under each treatment i.e. 4 weeks
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: Georg-Haas-Dialysezentrum der PHV
state: Hessen
city: Aachen
country: Germany
facility: RWTH University Hospital, Dpt for Nephrology
state: NRW
city: Erfurt
country: Germany
facility: Nephro-Studien GbR am Klinikum Erfurt
city: Flensburg
country: Germany
facility: Dialysezentrum
city: Hamburg
country: Germany
facility: Nephrocare Hamburg-Barmbek GmbH
city: Hannover
country: Germany
facility: Dialysezentrum
city: Kiel
country: Germany
facility: Dialysezentrum
city: Magdeburg
country: Germany
facility: Dialysezentrum
city: Minden
country: Germany
facility: Dialysezentrum
city: Solingen
country: Germany
facility: Dialysezentrum
city: Velbert
country: Germany
facility: Dialysezentrum
Study officials:
affiliation: University Aachen
name: Jürgen Floege, MD
role: PRINCIPAL_INVESTIGATOR
References: