CClinicalTrials.gg
Status unknownNCT01346215Updated May 2, 2011

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

A Phase 3 interventional study of heparin sodium and heparin sodium in Chronic Renal Failure, sponsored by Laboratório Químico Farmacêutico Bergamo Ltda.. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-02.

Sponsored by Laboratório Químico Farmacêutico Bergamo Ltda. · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Renal Failure

Keywords

  • heparin
  • renal insufficiency, chronic
  • extracorporeal dialysis
  • fibrinolytic agents
  • anticoagulants
  • aPTT
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 132 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

This is the only study on the registry with Laboratório Químico Farmacêutico Bergamo Ltda. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
132 participants (estimated)

Study arms

  • Experimental
    Actparin® - Laboratorio Bergamo

    Biological: heparin sodium

  • Active comparator
    Heparin sodium - APP Pharmaceuticals

    Biological: heparin sodium

Interventions

  • Biologicalheparin sodium

    5000 UI/mL

  • Biologicalheparin sodium

    5000 UI/mL

06

What researchers measure

Primary outcomes

  1. Effectiveness in prevention of clotting in the extracorporeal circuit during hemodialysis

    Time frame: 4 weeks (12 consecutive sessions)

Secondary outcomes

  1. Pharmacodynamic activity of heparin observed through aPTT marker

    Time frame: 4 weeks (sessions 1, 6 and 12)

  2. Safety in use of heparin by monitoring adverse events

    Time frame: 5 weeks (12 consecutive sessions + 1 post treatment session)

07

Study locations

1 site
  • Instituto de Nefrologia de Campinas
    Campinas, São Paulo, Brazil
    • Marcelo Orlandi · Contact
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01346215
Lead sponsor
Laboratório Químico Farmacêutico Bergamo Ltda.
Collaborators
Azidus Brasil
First posted
May 2, 2011
Start date
Oct 2011
Primary completion
Dec 2011 (estimated)
Completion
Feb 2012 (estimated)
Last update
May 2, 2011

Study contacts

Marcelo A. C. Orlandi, Dr.
Contact
Marcelo A. C. Orlandi, Dr.
principal investigator · Instituto de Nefrologia de Campinas

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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