Anemia in Chronic Renal Disease Clinical Trial
Official title:
Phase IV Study of Iron Indices' Kinetics in Hemodialysis Patients
| Verified date | September 2006 |
| Source | Papageorgiou General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Greece: Ministry of Health and Welfare |
| Study type | Interventional |
The purpose of this study is to describe alterations of serum ferritin, transferrin saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes, reticulocyte hemoglobin content after iron loading in hemodialysis patients.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | January 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - hemodialysis for three months minimum - stable epoetin dose for two months minimum - serum ferritin concentration < 1000 ng/ml - transferrin saturation < 50% - parathormone concentration < 800 pg/ml Exclusion Criteria: - hemoglobin concentration > 13g/dl - serum ferritin concentration < 20 ng/ml - vitamin B12 and/or folic deficiency - other hematologic disease than anemia - cancer - hypothyroidism - infectious disease |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Greece | Papageorgiou General Hospital | Thessaloniki |
| Lead Sponsor | Collaborator |
|---|---|
| Papageorgiou General Hospital |
Greece,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ferritin alterations after iron loading at six and twelve weeks from the beginning of iron loading. | |||
| Secondary | All iron indices' alterations during twelve weeks from the beginning of iron loading. |