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

Thrombus Clinical Trial

— HEPHIP0509  

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00914472
• Other study ID #: HEPHIP0509
• Secondary ID: Version 01
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 4, 2009
• Last updated: October 26, 2010
• Start date: April 2010

Study information

• Verified date: December 2009
• Source: L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency
• Thrombus

Intervention

Biological:
• heparin sodium - APP
Heparin 5000 IU / mL
• Heparin sodium - Hipolabor
Heparin 5000 IU / mL

Locations

Country	Name	City	State
Brazil	Lal Clinica Pesquisa E Desenvolvimento Ltda	Valinhos	SP

Sponsors (1)

Lead Sponsor	Collaborator
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 of heparin in thrombi formation.	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.	12 consecutive sessions	No
Secondary	Alteration of the pharmacodynamic parameters.	During 4 weeks (3 times/week)of treatment will be avaluate evoluation fo TTPA and ANTI-XA.	12 consecutive sessions.	No
Secondary	Evaluation of Anti-Xa		12 consecutive sessions (4 weeks - 3times/week)	No