Long-term Study in Chronic Kidney Disease Patients With H... | NCT01742611

Studies
Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on Dialysis

NCT01742611

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Jun 9, 2015Estimated

Enrollment

105Actual

Phase

Phase 3

Conditions

Chronic Kidney Disease
Renal Insufficiency
Hyperphosphatemia

Interventions

ASP1585

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

Jun 2015

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

Mar 2013

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Dec 4, 2012

First Submission Date that Met QC Criteria

Dec 4, 2012

First Posted Date

Dec 5, 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

Jun 8, 2015

Last Update Posted Date

Jun 9, 2015Estimated

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

This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease patients with hyperphosphatemia not on 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

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASP1585 group	Experimental		Drug: ASP1585

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ASP1585	Drug	oral	ASP1585 group	LY101 AMG223

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time-course changes in serum phosphorus levels		During 48 week treatment

Secondary Outcomes

Measure	Description	Time Frame
Achievement rate of the target range of serum phosphorus level		During 48 week treatment
Time to achieve the target range of serum phosphorus level		During 48 week treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who completed study 1585-CL-0101 or new patients who meet following criteria
Chronic kidney disease patients (eGFR < 60 mL/min/1.73 m2)
Serum phosphorus measurement ≧4.6 mg/dl, <9.0 mg/dl
Written informed consent

Exclusion Criteria:

Patients with gastrointestinal surgery or enterectomy
Patients with severe cardiac diseases
Patients with severe constipation or diarrhea
Patients with a history or complication of malignant tumors
Patients with uncontrolled hypertension
Patients treated with parathyroid intervention

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Director	Astellas Pharma Inc	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D054559	Hyperphosphatemia

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000589735	bixalomer

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Chūbu			Japan