Role of Prohepcidin in Uremic Patients

NCT01735773 | Completed

• 1 other identifier: HEPCIDIN-HASEKI
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Chronic Kidney Disease

Keywords

hemodialysis; inflammation; iron; peritoneal dialysis; prohepcidin; uremia

Outcome Measures

Primary Outcomes (1)

• prohepcidin level

  Prohepcidin levels will be compared with other inflammatory markers.

  Six months

Secondary Outcomes (1)

• Anemia and inflammatory markers

  Six months

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Haseki Training and Research Hospital: lead

Study Sites (1)

Haseki Training and Research Hospital

Istanbul, 34390, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Inflammation; Renal Insufficiency, Chronic; Uremia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 28, 2012
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

TU (1)