Role of Prohepcidin in Uremic Patients | NCT01735773

Studies
Role of Prohepcidin in Uremic Patients

NCT01735773

Sponsor

Haseki Training and Research Hospital

Status

Completed

Last Update Posted

Nov 28, 2012Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Inflammation
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

Nov 2012

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 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Nov 26, 2012

First Submission Date that Met QC Criteria

Nov 27, 2012

First Posted Date

Nov 28, 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

Nov 27, 2012

Last Update Posted Date

Nov 28, 2012Estimated

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 investigators aimed to study the effect of prohepcidin levels on hematologic parameters and inflammatory markers in non-diabetic uremic patients. The investigators selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. A control group was formed from healthy volunteers also. Each group has been planned to be formed of about 25 patients. Diabetic patients were excluded. Prohepcidin, hsCRP, IL-6, fibrinogen have been planned to be studied besides other routine biochemical analysis including hematological ones.

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

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hemodialysis group		Patients on chronic hemodialysis program
Peritoneal dialysis group		Patients on chronic peritoneal dialysis program
Pre-dialysis group		Patients with chronic kidney disease stage-4
Control group		Healthy volunteers

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prohepcidin level	Prohepcidin levels will be compared with other inflammatory markers.	Six months

Secondary Outcomes

Measure	Description	Time Frame
Anemia and inflammatory markers	Correlations of prohepcidin levels with anemia and inflamatory markers	Six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hemodialysis and peritoneal dialysis patients who had been on dialysis therapy for more than 3 months,
age between 18-80 years,
patients with creatinine clearance between 15-30 ml/min.

Exclusion Criteria:

age less than 18 or more than 80,
diabetic patients,
current active infectious or inflammatory disease.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

We selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. A control group was formed from healthy volunteers also.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haseki Training and Research Hospital		Istanbul		34390	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation
D051436	Renal Insufficiency, Chronic
D014511	Uremia

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D051437	Renal Insufficiency
D007674	Kidney Diseases

Browse Leaves

Not provided

Browse Branches

Not provided