Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Azidus Brasil | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório QuÃmico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actparin® - Laboratorio Bergamo | Experimental |
| |
| Heparin sodium - APP Pharmaceuticals | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heparin sodium | Biological | 5000 UI/mL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis | 4 weeks (12 consecutive sessions) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic activity of heparin observed through aPTT marker | 4 weeks (sessions 1, 6 and 12) | |
| Safety in use of heparin by monitoring adverse events | 5 weeks (12 consecutive sessions + 1 post treatment session) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcelo A. C. Orlandi, Dr. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Marcelo A. C. Orlandi, Dr. | Instituto de Nefrologia de Campinas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Nefrologia de Campinas | Campinas | São Paulo | Brazil |
Not provided
| Label | URL |
|---|---|
| MedlinePlus | View source |
| Blood thinners | View source |
| Dialysis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| heparin sodium |
| Biological |
5000 UI/mL |
|
| Kidney failure | View source |
| Drug Information | View source |
| Heparin | View source |
| U.S. FDA Resources | View source |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided