NCT00767637

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2005

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
Last Updated

June 20, 2014

Status Verified

June 1, 2014

Enrollment Period

3.3 years

First QC Date

October 6, 2008

Last Update Submit

June 19, 2014

Conditions

HyperphosphatemiaDialysis

Outcome Measures

Primary Outcomes (1)

  • Changes in pre-dialysis serum phosphate levels

    Every 2 weeks

Secondary Outcomes (5)

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

    Every 2 weeks

  • Changes in corrected serum calcium level

    Every 2 weeks

  • Changes in the product of serum calcium and phosphate

    Every 2 weeks

  • Changes in serum intact-PHT levels

    Every 2 weeks

  • Changes in bone metabolism markers

    Every 2 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Lanthanum Carbonate (BAY77-1931)

Interventions

Lanthanum Carbonate (BAY77-1931)DRUG

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

Arm 1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing dialysis or plan to start dialysis before the initial administration of the study medication

You may not qualify if:

  • Patients with severe hypocalcemia (adjusted serum calcium level of \<7.5 mg/dL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Isesaki, Gunma, 379-2211, Japan

Location

Unknown Facility

Yonago, Tottori, 683-0002, Japan

Location

Related Publications (1)

  • Shigematsu T, Tokumoto A, Nakaoka A, Arisaka H. Effect of lanthanum carbonate treatment on bone in Japanese dialysis patients with hyperphosphatemia. Ther Apher Dial. 2011 Apr;15(2):176-84. doi: 10.1111/j.1744-9987.2010.00898.x.

    PMID: 21426511DERIVED

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2008

First Posted

October 7, 2008

Study Start

June 1, 2005

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

June 20, 2014

Record last verified: 2014-06

Locations

JP(2)