| Trial ID: | L0676 |
| Source ID: | NCT00384657
|
| Associated Drug: |
Iron Sucrose
|
| Title: |
Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Chronic Heart Failure|Anemia
|
| Interventions: |
DRUG: iron sucrose
|
| Outcome Measures: |
Primary: percentage of patients with increased ejection fraction, 12 months | Secondary: the need for blood transfusions during the study period, 12 months|serum ferritin level, 12 months|transferrin saturation, 12 months|radial myocardial velocities, 12 months|right ventricular function, 12 months|global diastolic function, 12 months|left ventricular mass index, 12 months|major cardiovascular events (myocardial infarction, acute pulmonary edema, stroke), 12 months|hospital admissions, 12 months|death of the patient (all causes deaths, cardiac deaths), 12 months|slope of GFR change, 12 months|"death" of the kidney (initiation of renal replacement therapy), 12 months
|
| Sponsor/Collaborators: |
Sponsor: Anemia Working Group Romania
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2008-01
|
| Completion Date: |
2017-12
|
| Results First Posted: |
|
| Last Update Posted: |
2017-12-22
|
| Locations: |
"Dr Carol Davila" Teaching Hospital of Nephrology, Bucharest, 010731, Romania|"Caritas" Teaching Hospital, Cardiology Department, Bucharest, Romania
|
| URL: |
https://clinicaltrials.gov/show/NCT00384657
|
