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Lanthanum Carbonate

Phase 3

Hyperphosphatemia | Small molecule | Nephrology |Bayer AG|Last Updated: Mar 14, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials3
Total Enrollment316

FDA Designations

No designations recorded

Clinical trial landscape

Lanthanum Carbonate · 3 trials · 2 indications

Phase 3 2Phase 2 1
NCT01514851Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium CarbonateHyperphosphatemia
COMPLETED259 Analytics
NCT01518387Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis PatientsHyperphosphatemia
COMPLETED43 Analytics
PHASE3COMPLETED
Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate
HyperphosphatemiaUnlock trial analytics
PHASE3COMPLETED
Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients
HyperphosphatemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period
baseline to week 8
Presence/absence of incidence of hypercalcemia up to 8 weeks
up to 8 weeks
Change from baseline in serum phosphate levels at the end of the treatment period
Baseline to Week 8
Changes in pre-dialysis serum phosphate levels
Every 2 weeks

Secondary Endpoints

Number of participants achieving target PSPL and time to achievement
up to 8 weeks
Serum calcium x phosphate product at the end of the double-blind treatment period
Week 8
Serum intact-PTH (Parathyroid) levels
Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL750-2250mg/day, tid (three times a day), 8 weeks
Arm 2ACTIVE_COMPARATOR1500-4500mg/day, tid, 8 weeks

Interventions

NameTypeDescription
Lanthanum carbonate (BAY77-1931)DRUG -
Calcium carbonateDRUG -
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and \<11.0 mg/dL at 1 week after the initiation of the washout period. * Out-patient * Undergoing hemodialysis three times per week for at least previous 3 consecutive months Exclusion Criteria: * Pre-dialysis serum phosphate l...

Countries:Japan
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Frequently asked questions about Lanthanum Carbonate

What is Lanthanum Carbonate used for?

Lanthanum Carbonate is used for hyperphosphatemia, a condition of elevated phosphate levels in the blood. It is being developed as a small molecule treatment for patients with this condition, including those on dialysis. The drug is currently in Phase 3 clinical development.

Who makes Lanthanum Carbonate?

Lanthanum Carbonate is being developed by Bayer AG, a pharmaceutical company. Bayer's ticker symbol is BAYRY. The drug is currently in Phase 3 clinical trials for the treatment of hyperphosphatemia.

What phase is Lanthanum Carbonate in?

Lanthanum Carbonate is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Three clinical trials have been completed, with a total enrollment of 316 patients.

What clinical trials is Lanthanum Carbonate in?

Lanthanum Carbonate has completed three clinical trials: NCT00767637, a Phase 2 study measuring lanthanum concentrations in bone; NCT01514851, a Phase 3 double-blind comparative study with calcium carbonate; and NCT01518387, an open study in peritoneal dialysis patients. All trials were conducted in Japan.

Is Lanthanum Carbonate the same as BAY77-1931?

Yes, Lanthanum Carbonate is also known as BAY77-1931. Clinical trials for the drug use this alternative name, such as NCT01514851, which is titled 'Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate'.