Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules

NCT02027662 | Completed Phase 2

• 1 other identifier: RP-OSV-02-D
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 11

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.

Conditions

Hyperphosphatemia; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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

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.

  Between the first and last visit under each treatment i.e. 4 weeks

Study Arms (2)

Osvaren Granules

EXPERIMENTAL

Osvaren Granules

Drug: Osvaren Granules

Osvaren film-coated tablets

ACTIVE COMPARATOR

Osvaren film-coated tablets

Drug: Osvaren film-coated tablets

Interventions

Osvaren Granules DRUG

Osvaren Granules

Osvaren film-coated tablets DRUG

Osvaren film-coated tablets

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

Study Sites (11)

Georg-Haas-Dialysezentrum der PHV

Giessen, Hesse, 35392, Germany

Location

RWTH University Hospital, Dpt for Nephrology

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Nephro-Studien GbR am Klinikum Erfurt

Erfurt, Germany

Location

Dialysezentrum

Flensburg, 24939, Germany

Location

Nephrocare Hamburg-Barmbek GmbH

Hamburg, 22297, Germany

Location

Dialysezentrum

Hanover, Germany

Location

Dialysezentrum

Kiel, 24106, Germany

Location

Dialysezentrum

Magdeburg, Germany

Location

Dialysezentrum

Minden, Germany

Location

Dialysezentrum

Solingen, Germany

Location

Dialysezentrum

Velbert, Germany

Location

Related Publications (1)

• Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

  PMID: 40576086 DERIVED

MeSH Terms

Conditions

Hyperphosphatemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Jürgen Floege, MD

  University Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: January 6, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

DE (11)