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

Phase 2CompletedNCT00769496

Bayer145 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

145

Conditions

Hyperphosphatemia

Interventions

BAY 77-1931DRUG

Lanthanum Carbonate (BAY 77-1931)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (14)

Unnamed facility

Toyohashi, Aichi-ken, Japan

Unnamed facility

Yatomi, Aichi-ken, Japan

Unnamed facility

Chiba, Chiba, Japan

Unnamed facility

Outcomes

Primary Outcomes

Changes in pre-dialysis serum phosphate levels

Time frame: Every 4 weeks

Secondary Outcomes

Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)

Time frame: Every 4 weeks

Changes in corrected serum calcium level

Time frame: Every 4 weeks

Changes in the product of serum calcium and phosphate

Time frame: Every 4 weeks

Changes in serum intact-PHT levels

Time frame: Every 4 weeks

Changes in bone metabolism markers

Time frame: Every 4 weeks

Data from ClinicalTrials.gov

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