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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperphosphatemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

750-2250mg/day, tid, 8 weeks

Group Type EXPERIMENTAL

Lanthanum Carbonate (BAY77-1931)

Intervention Type DRUG

Interventions

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Lanthanum Carbonate (BAY77-1931)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No