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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01346215

Enrollment

132

Registered

2011-05-02

Start date

2011-10-31

Completion date

2012-02-29

Last updated

2011-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure

Keywords

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

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.

Interventions

BIOLOGICALheparin sodium

5000 UI/mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis	4 weeks (12 consecutive sessions)

Secondary

Measure	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)

Countries

Brazil

Contacts

Primary ContactMarcelo A. C. Orlandi, Dr.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026