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| ID | Type | Description | Link |
|---|---|---|---|
| Iron-Predialysis-2003 |
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The objective of this study is the evaluation of the efficacy and safety of intravenous iron sucrose in anemic patients with chronic kidney disease not on renal replacement therapy.
This is a randomized, open label, phase IV study in anemic predialysis patients (Hb between 8 and 11.5 g/dl) who require iron supplementation. The duration of the study for each patient will be approximately 6 months. Patients will be randomized to one of two treatment arms and admitted to the anemia correction phase (days 1-43). Treatment will be intravenous iron sucrose alone versus iron sucrose plus rhEPO. The main treatment evaluation will at the end of the correction phase: The primary end-point will be the change of hemoglobin during correction phase. Secondary end-points will be the change of ferritin and transferrin saturation from baseline to day 43. Safety assessments will include recording of adverse events, vital signs, physical examinations and clinical laboratory tests. Incidence and severity of adverse events will be compared between the two different treatment arms.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron sucrose | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin from baseline to day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ferritin and transferrin saturation from baseline to day 43; incidence and severity of adverse events |
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Inclusion Criteria:
Chronic kidney disease Anemia (Hb 8 - 11.5 g/dl) Age above 18 years Signed informed consent
Exclusion Criteria:
Rapid progression of kidney disease Need for dialysis Uncontrolled hypertension
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| Name | Affiliation | Role |
|---|---|---|
| Roland M Schaefer, MD | University Hospital Muenster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Muenster | Münster | Westphalia | 48149 | Germany |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |