BAY 77-1931 Long-term Extension From Phase II Study

A Long-term, Open Label Extension, Non-controlled Study to Assess the Efficacy and Safety of BAY 77-1931 (Lanthanum Carbonate) for Hyperphosphatemia in Patients Undergoing Hemodialysis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00769496

Enrollment

145

Registered

2008-10-09

Start date

2005-01-31

Completion date

2008-05-31

Last updated

2013-01-23

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

Conditions

Hyperphosphatemia

Brief summary

A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis

Interventions

DRUGBAY 77-1931

Lanthanum Carbonate (BAY 77-1931)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least

Exclusion criteria

* Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period

Design outcomes

Primary

Measure	Time frame
Changes in pre-dialysis serum phosphate levels	Every 4 weeks

Secondary

Measure	Time frame
Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)	Every 4 weeks
Changes in corrected serum calcium level	Every 4 weeks
Changes in the product of serum calcium and phosphate	Every 4 weeks
Changes in serum intact-PHT levels	Every 4 weeks
Changes in bone metabolism markers	Every 4 weeks

Countries

Japan

Outcome results

None listed

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