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

June 19, 2014 updated by: Bayer

Open Label, Non-controlled Long-term Treatment on BAY77-1931 (Lanthanum Carbonate) to Measure Lanthanum Concentrations in Bone in Patients With Hyperphosphatemia Receiving Dialysis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Gunma
      • Isesaki, Gunma, Japan, 379-2211
    • Tottori
      • Yonago, Tottori, Japan, 683-0002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Drug: Lanthanum Carbonate (BAY77-1931)
BAY77-1931 750mg, in the morning, day and evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in pre-dialysis serum phosphate levels
Time Frame: Every 2 weeks
Every 2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)
Time Frame: Every 2 weeks
Every 2 weeks
Changes in corrected serum calcium level
Time Frame: Every 2 weeks
Every 2 weeks
Changes in the product of serum calcium and phosphate
Time Frame: Every 2 weeks
Every 2 weeks
Changes in serum intact-PHT levels
Time Frame: Every 2 weeks
Every 2 weeks
Changes in bone metabolism markers
Time Frame: Every 2 weeks
Every 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

October 6, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (ESTIMATE)

October 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2014

Last Update Submitted That Met QC Criteria

June 19, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11810
  • Fosrenol (OTHER: Company Internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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