Post-marketing Surveillance of Kiklin Capsules in Hemodia... | NCT01901107

Studies
Post-marketing Surveillance of Kiklin Capsules in Hemodialysis Patients

NCT01901107

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Jan 27, 2017Estimated

Enrollment

1,078Actual

Phase

Not provided

Conditions

Chronic Renal Failure Patients With Hyperphosphataemia Receiving Hemodialysis

Interventions

Kiklin capsules

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 2017

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 2013

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jul 1, 2013

First Submission Date that Met QC Criteria

Jul 15, 2013

First Posted Date

Jul 17, 2013Estimated

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 26, 2017

Last Update Posted Date

Jan 27, 2017Estimated

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 survey is to evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.

Detailed Description

Bixalomer is administered at initial oral dosage of 500 mg three times a day just before a meal. The dosage can be adjusted based on symptoms and serum phosphorus level.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,078Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Kiklin group			Drug: Kiklin capsules

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kiklin capsules	Drug	oral	Kiklin group	ASP1585 ILY101

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety assessed by the incidence of adverse events, physical exam and lab-tests		for one year

Secondary Outcomes

Measure	Description	Time Frame
Serum phosphate level		Baseline and 1, 2, 3, 6, 12 months after administration
Serum calcium level		Baseline and 1, 2, 3, 6, 12 months after administration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Chronic renal failure patients with hyperphosphataemia receiving hemodialysis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Chronic renal failure patients with hyperphosphataemia receiving hemodialysis

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D054559	Hyperphosphatemia

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

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	Chubu		Japan