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

NCT01346215 | Unknown Phase 3 DMC

• 1 other identifier: HEPBER0211
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Renal Failure

Keywords

heparin; renal insufficiency, chronic; extracorporeal dialysis; fibrinolytic agents; anticoagulants; aPTT

Outcome Measures

Primary Outcomes (1)

• Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis

  4 weeks (12 consecutive sessions)

Secondary Outcomes (2)

• 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)

Study Arms (2)

Actparin® - Laboratorio Bergamo

EXPERIMENTAL

Biological: heparin sodium

Heparin sodium - APP Pharmaceuticals

ACTIVE COMPARATOR

Biological: heparin sodium

Interventions

heparin sodium BIOLOGICAL

5000 UI/mL

Actparin® - Laboratorio Bergamo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratório Químico Farmacêutico Bergamo Ltda.: lead
• Azidus Brasil: collaborator

Study Sites (1)

Instituto de Nefrologia de Campinas

Campinas, São Paulo, Brazil

Location

Related Links

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

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Interventions

Heparin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Marcelo A. C. Orlandi, Dr.

  Instituto de Nefrologia de Campinas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo A. C. Orlandi, Dr.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: May 2, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: May 2, 2011

Record last verified: 2011-04

Locations

BR (1)