Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone

Phase 2CompletedNCT00767637

Bayer14 enrolled

Overview

To measure lanthanum concentrations in bone in patients with hyperphosphatemia receiving dialysis

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperphosphatemia Dialysis

Interventions

Lanthanum Carbonate (BAY77-1931)DRUG

BAY77-1931 750mg, in the morning, day and evening

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication Exclusion Criteria: * Patients with severe hypocalcemia (adjusted serum calcium level of \<7.5 mg/dL)

Locations (2)

Unnamed facility

Isesaki, Gunma, Japan

Unnamed facility

Yonago, Tottori, Japan

Outcomes

Primary Outcomes

Changes in pre-dialysis serum phosphate levels

Time frame: Every 2 weeks

Secondary Outcomes

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

Time frame: Every 2 weeks

Changes in corrected serum calcium level

Time frame: Every 2 weeks

Changes in the product of serum calcium and phosphate

Time frame: Every 2 weeks

Changes in serum intact-PHT levels

Time frame: Every 2 weeks

Changes in bone metabolism markers

Time frame: Every 2 weeks

Data from ClinicalTrials.gov

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