Role of Prohepcidin in Uremic Patients

Inflammation Clinical Trial

Official title:

The Relationship of Prohepcidin Levels With Anemia and Inflammatory Markers in Non-diabetic Uremic Patients: A Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735773
• Other study ID #: HEPCIDIN-HASEKI
• Status: Completed
• Phase: N/A
• First received: November 26, 2012
• Last updated: November 27, 2012
• Start date: January 2010
• Est. completion date: March 2011

Study information

• Verified date: November 2012
• Source: Haseki Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Inflammation
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Turkey	Haseki Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prohepcidin level	Prohepcidin levels will be compared with other inflammatory markers.	Six months	No
Secondary	Anemia and inflammatory markers	Correlations of prohepcidin levels with anemia and inflamatory markers	Six months	No