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NCT Number: NCT02027662

Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules

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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Key information

Conditions

Hyperphosphatemia Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Georg-Haas-Dialysezentrum der PHV, Giessen, Hesse, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osvaren Granules

Drug

Osvaren film-coated tablets

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Registry information

Official study title

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

Acronym: OsvaRenNEW

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2014
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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