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

Primary Purpose

Hyperphosphatemia

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

BAY 77-1931

About this trial

This is an interventional treatment trial for Hyperphosphatemia

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Changes in pre-dialysis serum phosphate levels

Secondary Outcome Measures

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

Changes in corrected serum calcium level

Changes in the product of serum calcium and phosphate

Changes in serum intact-PHT levels

Changes in bone metabolism markers

Full Information

NCT ID

NCT00769496

First Posted

October 8, 2008

Last Updated

January 21, 2013

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00769496

Brief Title

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

Official Title

A Long-term, Open Label Extension, Non-controlled Study to Assess the Efficacy and Safety of BAY 77-1931 (Lanthanum Carbonate) for Hyperphosphatemia in Patients Undergoing Hemodialysis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperphosphatemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

145 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BAY 77-1931

Intervention Description

Lanthanum Carbonate (BAY 77-1931)

Primary Outcome Measure Information:

Title

Changes in pre-dialysis serum phosphate levels

Time Frame

Every 4 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

Every 4 weeks

Title

Changes in corrected serum calcium level

Time Frame

Every 4 weeks

Title

Changes in the product of serum calcium and phosphate

Time Frame

Every 4 weeks

Title

Changes in serum intact-PHT levels

Time Frame

Every 4 weeks

Title

Changes in bone metabolism markers

Time Frame

Every 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Toyohashi

State/Province

Aichi

ZIP/Postal Code

441-8023

Country

Japan

City

Yatomi

State/Province

Aichi

ZIP/Postal Code

498-0006

Country

Japan

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-0084

Country

Japan

City

Narita

State/Province

Chiba

ZIP/Postal Code

286-0041

Country

Japan

City

Sakura

State/Province

Chiba

ZIP/Postal Code

285-0846

Country

Japan

City

Asahikawa

State/Province

Hokkaido

ZIP/Postal Code

070-0030

Country

Japan

City

Suita

State/Province

Osaka

ZIP/Postal Code

564-0053

Country

Japan

City

Chiba

ZIP/Postal Code

261-0011

Country

Japan

City

Hiroshima

ZIP/Postal Code

730-0811

Country

Japan

City

Kochi

ZIP/Postal Code

780-0066

Country

Japan

City

Kochi

ZIP/Postal Code

780-8040

Country

Japan

City

Kochi

ZIP/Postal Code

781-5103

Country

Japan

City

Okayama

ZIP/Postal Code

701-0202

Country

Japan

City

Tokushima

ZIP/Postal Code

770-0011

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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