Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure

Chronic Renal Failure Clinical Trial

Official title:

Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01346215
• Other study ID #: HEPBER0211
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 28, 2011
• Last updated: April 29, 2011
• Start date: October 2011
• Est. completion date: February 2012

Study information

• Verified date: April 2011
• Source: Laboratório Químico Farmacêutico Bergamo Ltda.
• Contact: Marcelo A. C. Orlandi , Dr.
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Biological:
• heparin sodium
5000 UI/mL
• heparin sodium
5000 UI/mL

Locations

Country	Name	City	State
Brazil	Instituto de Nefrologia de Campinas	Campinas	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Laboratório Químico Farmacêutico Bergamo Ltda.	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis		4 weeks (12 consecutive sessions)	No
Secondary	Pharmacodynamic activity of heparin observed through aPTT marker		4 weeks (sessions 1, 6 and 12)	No
Secondary	Safety in use of heparin by monitoring adverse events		5 weeks (12 consecutive sessions + 1 post treatment session)	Yes

External Links

•   Blood thinners
•   Dialysis
•   Drug Information
•   Heparin
•   Kidney failure
•   MedlinePlus
•   U.S. FDA Resources