Trial record 17 of 740 for:
Open Studies | "Kidney Failure"
Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Laboratório Químico Farmacêutico Bergamo Ltda..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Laboratório Químico Farmacêutico Bergamo Ltda.
Collaborator:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:
Laboratório Químico Farmacêutico Bergamo Ltda.
ClinicalTrials.gov Identifier:
NCT01346215
First received: April 28, 2011
Last updated: April 29, 2011
Last verified: April 2011
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Purpose
The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Renal Failure |
Biological: heparin sodium |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure |
Resource links provided by NLM:
Further study details as provided by Laboratório Químico Farmacêutico Bergamo Ltda.:
Primary Outcome Measures:
- Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis [ Time Frame: 4 weeks (12 consecutive sessions) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacodynamic activity of heparin observed through aPTT marker [ Time Frame: 4 weeks (sessions 1, 6 and 12) ] [ Designated as safety issue: No ]
- Safety in use of heparin by monitoring adverse events [ Time Frame: 5 weeks (12 consecutive sessions + 1 post treatment session) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 132 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Actparin® - Laboratorio Bergamo |
Biological: heparin sodium
5000 UI/mL
|
| Active Comparator: Heparin sodium - APP Pharmaceuticals |
Biological: heparin sodium
5000 UI/mL
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients research that agree to participate in the study and sign the informed consent form;
- Patients aged over 18 years, both sexes, regardless of color or social class;
- Patients with impaired renal function in chronic hemodialysis schedule of at least 3 times a week and giving the use of heparin in the prophylaxis of thrombosis in the system;
- Patients with laboratory results within specified acceptance criteria.
Exclusion Criteria:
- Patients who are taking part or took part in another clinical investigational study within 12 months;
- Hypersensitivity to heparin sodium and/or benzyl alcohol;
- History of active hemorrhage with alteration of blood coagulation, such as genetic disorders of coagulation system;
- History of disease that could aggravate or terminate the clinical manifestations, such as active peptic or gastric ulcer;
- Severe liver disease;
- Patients in cancer treatment;
- Pregnant and lactating women;
- Use of glucocorticoids over physiological dose;
- Use of other anticoagulants;
- Patients undergoing any surgery performed less than 15 days;
- History of non response or exacerbated response to heparin sodium;
- Patients who do not adapt to 150 UI/kg dose.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346215
Contacts
| Contact: Marcelo A. C. Orlandi , Dr. |
Locations
| Brazil | |
| Instituto de Nefrologia de Campinas | Not yet recruiting |
| Campinas, São Paulo, Brazil | |
| Contact: Marcelo Orlandi | |
Sponsors and Collaborators
Laboratório Químico Farmacêutico Bergamo Ltda.
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Investigators
| Principal Investigator: | Marcelo A. C. Orlandi, Dr. | Instituto de Nefrologia de Campinas |
More Information
Additional Information:
No publications provided
| Responsible Party: | Marcelo A. C. Orlandi, Instituto de Nefrologia de Campinas |
| ClinicalTrials.gov Identifier: | NCT01346215 History of Changes |
| Other Study ID Numbers: | HEPBER0211 |
| Study First Received: | April 28, 2011 |
| Last Updated: | April 29, 2011 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Laboratório Químico Farmacêutico Bergamo Ltda.:
|
heparin renal insufficiency, chronic extracorporeal dialysis |
fibrinolytic agents anticoagulants aPTT |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Fibrinolytic Agents Heparin Calcium heparin |
Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents Anticoagulants |
ClinicalTrials.gov processed this record on May 21, 2013