Recent Updates
Recently added Catalysts

Osvaren Granules

Phase 2

Hyperphosphatemia | Small molecule | Nephrology |Fresenius Medical Care AG|Last Updated: Jun 10, 2015

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment61

FDA Designations

No designations recorded

Clinical trial landscape

Osvaren Granules · 1 trial · 2 indications

Phase 2 1
NCT02027662Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® GranulesHyperphosphatemia
COMPLETED61 Analytics
PHASE2COMPLETED
Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules
Hyperphosphatemia
NCT0202766261
Unlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Osvaren GranulesEXPERIMENTALOsvaren Granules
Osvaren film-coated tabletsACTIVE_COMPARATOROsvaren film-coated tablets

Interventions

NameTypeDescription
Osvaren GranulesDRUG -
Osvaren film-coated tabletsDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites11

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 eith...

Countries:Germany
Unlock Eligibility Criteria

Frequently asked questions about Osvaren Granules

What is Osvaren Granules used for?

Osvaren Granules is an investigational small molecule being developed for hyperphosphatemia, a condition of elevated phosphate levels in the blood. It is intended for patients with chronic kidney disease who have hyperphosphatemia. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes Osvaren Granules?

Osvaren Granules is being developed by Fresenius Medical Care AG, a company traded on the New York Stock Exchange under the ticker FMS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with hyperphosphatemia associated with chronic kidney disease.

What phase is Osvaren Granules in?

Osvaren Granules is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies such as the FDA. The drug is being studied for the treatment of hyperphosphatemia in patients with chronic kidney disease, and its clinical trial has been completed.

What clinical trials is Osvaren Granules in?

Osvaren Granules has one completed clinical trial, identified as NCT02027662. This Phase 2 study, titled 'Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules,' enrolled 61 participants with hyperphosphatemia and chronic kidney disease. The trial was conducted in Germany and included adults aged 18 years and older.

Is Osvaren Granules the same as OsvaRen?

Osvaren Granules is a formulation of the drug OsvaRen, which is also available as tablets. The clinical trial NCT02027662 was designed to assess the therapeutic equivalence of OsvaRen tablets and OsvaRen granules. Both formulations contain the same active ingredients, but the granules are a different dosage form.