| Trial ID: | L1523 |
| Source ID: | NCT00236977
|
| Associated Drug: |
Venofer
|
| Title: |
Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00236977/results
|
| Conditions: |
Anemia
|
| Interventions: |
DRUG: Venofer|DRUG: Ferrous Sulfate
|
| Outcome Measures: |
Primary: Patients With an Increase in Hemoglobin >= 1gm/dL., Change from Baseline up to Day 56 | Secondary: Number of Subjects With a Clinical Response, Clinical Response (change in Hemoblobin (Hgb) \>= 1gm/dL and change in ferritin \>= 160ng/ml), Change from Baseline up to Day 56|Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56, Change from Baseline up to Day 56|Highest Change From Baseline in Ferritin (ng/mL) up to Day 56, Change from Baseline up to Day 56|Mean Change in Ferritin (ng/mL) From Baseline to Day 56, Change from Baseline at Day 56|Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56, Change from Baseline at Day 56|Mean Change From Baseline in Hemoglobin (g/dL) at Day 56, Change from Baseline at Day 56
|
| Sponsor/Collaborators: |
Sponsor: American Regent, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
182
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2003-08
|
| Completion Date: |
2004-10
|
| Results First Posted: |
2010-03-09
|
| Last Update Posted: |
2020-10-06
|
| Locations: |
Luitpold Pharmaceuticals, Valley Forge, Pennsylvania, 19403, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00236977
|
