Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure. (HEPHIP0509)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00914472
First received: June 4, 2009
Last updated: October 26, 2010
Last verified: December 2009
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Thrombus |
Biological: heparin sodium - APP Biological: Heparin sodium - Hipolabor |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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. |
Resource links provided by NLM:
Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
Primary Outcome Measures:
- Effectiveness of heparin in thrombi formation. [ Time Frame: 12 consecutive sessions ] [ Designated as safety issue: No ]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 Outcome Measures:
- Alteration of the pharmacodynamic parameters. [ Time Frame: 12 consecutive sessions. ] [ Designated as safety issue: No ]During 4 weeks (3 times/week)of treatment will be avaluate evoluation fo TTPA and ANTI-XA.
- Evaluation of Anti-Xa [ Time Frame: 12 consecutive sessions (4 weeks - 3times/week) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Test
Heparin - Hipolabor
|
Biological: Heparin sodium - Hipolabor
Heparin 5000 IU / mL
|
|
Active Comparator: Ative comparator
Heparin - APP
|
Biological: heparin sodium - APP
Heparin 5000 IU / mL
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Research that patients agreed to participate and signed the written informed consent;
- 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.
Exclusion Criteria:
- Hypersensitivity to heparin sodium and / or benzyl alcohol;
- 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;
- Severe liver disease;
- Cancer;
- Period of gestation;
- Genetic abnormality of the coagulation system;
- Multiple trauma;
- Use of aspirin in high doses (above 200mg per day);
- Use of glucocorticoids for at least 1 month;
- Use of other anticoagulants;
- Submission of a big surgery done less than 15 days;
- History of persistent hypertension at the end of dialysis than 150/100 mmHg;
- Indicated doses of heparin 20% above or below 150UI/kg.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Alexandre Frederico, LAL Clinica Pesquisa e Desenvolvimento Ltda |
| ClinicalTrials.gov Identifier: | NCT00914472 History of Changes |
| Other Study ID Numbers: | HEPHIP0509, Version 01 |
| Study First Received: | June 4, 2009 |
| Last Updated: | October 26, 2010 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
|
Preventing the thrombi formation |
Additional relevant MeSH terms:
|
Kidney Failure, Chronic Renal Insufficiency Thrombosis Renal Insufficiency, Chronic Kidney Diseases Urologic Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Calcium heparin |
Heparin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013