Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate

Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01514851

Enrollment

259

Registered

2012-01-23

Start date

2006-01-31

Completion date

2006-05-31

Last updated

2012-06-08

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

Conditions

Hyperphosphatemia

Keywords

Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis

Brief summary

To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.

Interventions

DRUGLanthanum carbonate (BAY77-1931)

DRUGCalcium carbonate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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 levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after * Corrected serum calcium level of \<7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 week after * Serum intact PTH (Parathyroid) of ≧1000 pg/mL at the start of the washout period * Pregnant woman, or lactating mother * Significant gastrointestinal disorders including known acute peptic ulcer * Liver dysfunction * History of cardiovascular or cerebrovascular diseases * Requiring treatment for hypothyroidism

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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
Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period	Week 8
Number of participants achieving the target serum calcium levels	Week 8
Safety variables will be summarized using descriptive statistics based on adverse events collection	8 weeks

Countries

Japan

Outcome results

None listed

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