| Trial ID: | L1575 |
| Source ID: | NCT00399269
|
| Associated Drug: |
Recombinant Human Erythropoietin Alpha
|
| Title: |
Efficacy & Safety Study of Recombinant Human Erythropoietin -Alpha, in Patients With Anemia of Chronic Renal Failure
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia
|
| Interventions: |
DRUG: Recombinant Human Erythropoietin alpha
|
| Outcome Measures: |
Primary: Rise in Hemoglobin (Hb)/ Hematocrit (Hct) to therapeutic levels of 10 to 12 g/ dL|and/ or 30 to 36% respectively suggestive of normalized erythropoiesis at the end of study period of 12 Weeks.|OR|Rise in Hb by 1 g/ dL over two weeks of treatment with rHu-EPO. | Secondary: Rise of Hemoglobin and Haematocrit in CRF patients without significant adverse events.
|
| Sponsor/Collaborators: |
Sponsor: Cadila Pharnmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-12
|
| Completion Date: |
2007-06
|
| Results First Posted: |
|
| Last Update Posted: |
2009-06-11
|
| Locations: |
Dr. Shishir Gang, Nadiad, Gujarat, India
|
| URL: |
https://clinicaltrials.gov/show/NCT00399269
|
