Liquaemin
DrugThe standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.
NCT Number: NCT05148377
The objective of this study was to verify the clinical non-inferiority of the pharmacodynamic effects and the safety of use of the drug Heptar® manufactured by Eurofarma Laboratory, compared to the drug Liquemine®, manufactured by by Roche Laboratory in patients with renal failure undergoing hemodialysis treatment
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparino tested. The study was conducted with the participation of 110 chronic renal failure patients of both sexes. over 18 years old who are undergoing hemodialysis treatment 3 times a week and who fit inclusion and exclusion criteria. The investigational products properly patients were administered during 12 consecutive treatment sessions. Hemodialysis at a dose of 150 IU per kg of weight. The study patients were followed clinically and on a laboratory basis in all hemodialysis sessions according to criteria established by the protocol for verifying the safety in use of the product in study.
The evaluation parameters are:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.
The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.
Other names: Sodium heparin
Time frame: 4 weeks
Evaluation of the change of the useful volume of the system below
Time frame: 4 weeks
Absolut difference of dialyzer lost between the two groups of treatment in the 12 hemodialysis sessions
Time frame: 4 weeks
Occurrence of events related to the reduction of the useful volume of the system below 80% by thrombus formation in the dialyzer in the 12 hemodialysis sessions
Eurofarma Laboratorios S.A.
Industry
Acronym: HEPIRC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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