Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

Phase III Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01518387

Enrollment

Registered

2012-01-26

Start date

2006-01-31

Completion date

2006-07-31

Last updated

2016-03-14

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

The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.

Interventions

DRUGLanthanum Carbonate (BAY77-1931)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Serum phosphate levels: \>5.0 mg/dL and \<11.0 mg/dL 2 weeks after the initiation of the washout period * Out-patient * Undergoing CAPD for at least previous 3 consecutive months

Exclusion criteria

* Who may not enable to continue CAPD * Serum phosphate levels of \>=10.0 mg/dL at the start of the washout period or \>=11.0 mg/dL 2 week after * Corrected serum calcium level of \<7.0 mg/dL at the start of the washout period or \>=11.0 mg/dL 2 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

Design outcomes

Primary

Measure	Time frame
Change from baseline in serum phosphate levels at the end of the treatment period	Baseline to Week 8

Secondary

Measure	Time frame
Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement	Week 8
Serum calcium level corrected by serum albumin level at the end of the treatment period	Week 8
Serum calcium x phosphate product at the end of the treatment period	Week 8
Serum intact-PTH (Parathyroid) levels at the end of the treatment period	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