Factors Related to the Progression of Chronic Kidney Disease | NCT01317173

Studies
Factors Related to the Progression of Chronic Kidney Disease

NCT01317173

Sponsor

Ankara Education and Research Hospital

Status

Unknown status

Last Update Posted

Mar 17, 2011Estimated

Enrollment

90Estimated

Phase

Not provided

Conditions

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

Jan 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

May 2011Estimated

Completion Date

Jun 2011Estimated

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

Chronic kidney disease is a progressive disorder that has been influenced with many factors. Most of the patients has altered Ca P metabolism and these dis orders are the contributing factors of the disease progression. It has been recently documented that FGF23 and Klotho are the key factors of PTH secretion Ca-P metabolism. This study aimed to evaluate the impact of Klotho and FGF23 on the progression of stage 3-4 chronic kidney disease.

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

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Progressive disease		Serum creatinin level rise more than 2 times
Non-progressive disease		Serum creatinin level rise less than 2 times

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression of kidney disease	Doubling of creatinin, requirement of renal replacement therapy	continuous measurement of kidney functions 3 monthly for two years or until the outcome reached

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of Ca P metabolism	Determination of Ca-P metabolism disorders.	3 monthly for two years or until the outcome reached

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Non-diabetic chronic kidney disease

Exclusion Criteria:

Presence of DM
Actively using calcium based phosphorus binder of vitamin D

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

Patients diagnosed with non-diabetic chronic kidney disease between the ages of 18 and 65 years old.

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		Ankara			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

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