The Role of FGF23 and Asymmetric Dimethylarginine (ADMA)... | NCT01317186

Studies
The Role of FGF23 and Asymmetric Dimethylarginine (ADMA) in Chronic Kidney Disease

NCT01317186

Sponsor

Ankara Education and Research Hospital

Status

Unknown status

Last Update Posted

Mar 17, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Metabolic Diseases
Chronic Kidney Disease

Interventions

Not provided

Countries

Turkey (Türkiye)

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 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 16, 2011

First Submission Date that Met QC Criteria

Mar 16, 2011

First Posted Date

Mar 17, 2011Estimated

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 16, 2011

Last Update Posted Date

Mar 17, 2011Estimated

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

In chronic kidney disease calcium (Ca) and phosphate (P) metabolism disorders are very common and also they are one of the leading causes of morbidity in these population. FGF23 is a novel factor that contributes Ca-P disorders. It has been hypothesized that FGF 23 increase is mediated by asymmetric dimethylarginine (ADMA). The aim of the study is to evaluate this hypothesis.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I		Stage 2 Non-diabetic Chronic Kidney Disease
Group II		Stage 3 Non-diabetic Chronic Kidney Disease
Group III		Stage 4 Non-diabetic Chronic Kidney Disease

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

between ages of 18 - 65 years old
chronic kidney disease of stage 2-4

Exclusion Criteria:

presence of diabetes mellitus or ischemic hearth disease
taking vitamin d therapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Stage 2-4 Non-diabetic Chronic Kidney Disease patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara Education and Research Hospital	Recruiting	Ankara			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D008659	Metabolic Diseases
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D009750	Nutritional and Metabolic Diseases
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

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Browse Branches

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