Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.

A Randomized Non-inferiority Clinical Trial of Heparin Produced by Hipolabor Laboratory(PARINEX®) in Comparation With Heparin Produced by APP PHARMACEUTICALS in Patients With Chronic Renal Failure.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00914472

Acronym

HEPHIP0509

Enrollment

120

Registered

2009-06-05

Start date

2010-04-30

Completion date

Unknown

Last updated

2010-10-27

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

Conditions

Thrombus

Keywords

Preventing the thrombi formation

Brief summary

Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA and Anti-Xa) during the use of heparin

Interventions

BIOLOGICALheparin sodium - APP

Heparin 5000 IU / mL

BIOLOGICALHeparin sodium - Hipolabor

Heparin 5000 IU / mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Research that patients agreed to participate and signed the written informed consent; 2. Patients aged over 18 years, both sexes, regardless of color or social class; 3. 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.

Exclusion criteria

1. Hypersensitivity to heparin sodium and / or benzyl alcohol; 2. History of bleeding or disease that the change of blood coagulation could aggravate or terminate the clinical manifestations, such as tables of active peptic or gastric ulcer; 3. Severe liver disease; 4. Cancer; 5. Period of gestation; 6. Genetic abnormality of the coagulation system; 7. Multiple trauma; 8. Use of aspirin in high doses (above 200mg per day); 9. Use of glucocorticoids for at least 1 month; 10. Use of other anticoagulants; 11. Submission of a big surgery done less than 15 days; 12. History of persistent hypertension at the end of dialysis than 150/100 mmHg; 13. Indicated doses of heparin 20% above or below 150UI/kg.

Design outcomes

Primary

Measure	Time frame	Description
Effectiveness of heparin in thrombi formation.	12 consecutive sessions	During 4 weeks (3 times/week)of treatment will be avaluete thrombi formation in the dialysis system and decrease in net volume of the capillary dialyzer (primming) under formation of fibrin.

Secondary

Measure	Time frame	Description
Alteration of the pharmacodynamic parameters.	12 consecutive sessions.	During 4 weeks (3 times/week)of treatment will be avaluate evoluation fo TTPA and ANTI-XA.
Evaluation of Anti-Xa	12 consecutive sessions (4 weeks - 3times/week)	—

Countries

Brazil

Outcome results

None listed

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