Open Study of BAY77-1931 (Lanthanum Carbonate) in Continu... | NCT01518387

Studies
Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients

NCT01518387

Sponsor

Bayer

Status

Completed

Last Update Posted

Mar 14, 2016Estimated

Enrollment

43Actual

Phase

Phase 3

Conditions

Hyperphosphatemia

Interventions

Lanthanum Carbonate (BAY77-1931)

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

Mar 2016

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 2006

Primary Completion Date

Jul 2006Actual

Completion Date

Jul 2006Actual

First Submitted Date

Jan 18, 2012

First Submission Date that Met QC Criteria

Jan 25, 2012

First Posted Date

Jan 26, 2012Estimated

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

Mar 10, 2016

Last Update Posted Date

Mar 14, 2016Estimated

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

Description Module

Brief Summary

The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.

Detailed Description

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	750-2250mg/day, tid, 8 weeks	Drug: Lanthanum Carbonate (BAY77-1931)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lanthanum Carbonate (BAY77-1931)	Drug		Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in serum phosphate levels at the end of the treatment period		Baseline to Week 8

Secondary Outcomes

Measure	Description	Time Frame
Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement		Week 8
Serum calcium level corrected by serum albumin level at the end of the treatment period		Week 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Serum phosphate levels: >5.0 mg/dL and <11.0 mg/dL 2 weeks after the initiation of the washout period
Out-patient
Undergoing CAPD for at least previous 3 consecutive months

Exclusion Criteria:

Who may not enable to continue CAPD
Serum phosphate levels of >=10.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
Corrected serum calcium level of <7.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
Serum intact PTH (Parathyroid) of >=1000 pg/mL at the start of the washout period
Pregnant woman, or lactating mother
Significant gastrointestinal disorders including known acute peptic ulcer
Liver dysfunction
History of cardiovascular or cerebrovascular diseases

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

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D054559	Hyperphosphatemia
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D051436	Renal Insufficiency, Chronic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C119467	lanthanum carbonate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Fukuoka	Fukuoka	815-0082	Japan