Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone

Open Label, Non-controlled Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone in Patients With Hyperphosphatemia Receiving Dialysis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00767637

Enrollment

Registered

2008-10-07

Start date

2005-06-30

Completion date

2008-10-31

Last updated

2014-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis, Hyperphosphatemia

Brief summary

To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis

Interventions

DRUGLanthanum Carbonate (BAY77-1931)

BAY77-1931 750mg, in the morning, day and evening

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication

Exclusion criteria

* Patients with severe hypocalcemia (adjusted serum calcium level of \<7.5 mg/dL)

Design outcomes

Primary

Measure	Time frame
Changes in pre-dialysis serum phosphate levels	Every 2 weeks

Secondary

Measure	Time frame
Changes in the product of serum calcium and phosphate	Every 2 weeks
Changes in serum intact-PHT levels	Every 2 weeks
Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)	Every 2 weeks
Changes in corrected serum calcium level	Every 2 weeks
Changes in bone metabolism markers	Every 2 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026