BAY 77-1931 Long-term Extension From Phase II Study | NCT00769496

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

NCT00769496

Sponsor

Bayer

Status

Completed

Last Update Posted

Jan 23, 2013Estimated

Enrollment

145Actual

Phase

Phase 2

Conditions

Hyperphosphatemia

Interventions

BAY 77-1931

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Oct 8, 2008

First Submission Date that Met QC Criteria

Oct 8, 2008

First Posted Date

Oct 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2013

Last Update Posted Date

Jan 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental		Drug: BAY 77-1931

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BAY 77-1931	Drug	Lanthanum Carbonate (BAY 77-1931)	Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in pre-dialysis serum phosphate levels		Every 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)		Every 4 weeks
Changes in corrected serum calcium level		Every 4 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Toyohashi	Aichi-ken	441-8023	Japan

Condition Browse Module

MeSH Terms

ID	Term
D054559	Hyperphosphatemia

Ancestor Terms

ID	Term
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided