A Phase 3 interventional study of Liquaemin and Heptar in Hemodialysis Complication, sponsored by Eurofarma Laboratorios S.A.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-27.
Sponsored by Eurofarma Laboratorios S.A. · Phase 3, Interventional, and Treatment
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
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:
Effectiveness in maintaining blood coagulation during hemodialysis.
Safety in drug use through event monitoring complicating the use of heparin as:
Eurofarma Laboratorios S.A. is the lead sponsor of 64 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sodium heparin (Heptar®) produced by Eurofarma Laboratory,
Drug: Heptar
Roche Lab's Liquemine®
Drug: Liquaemin
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.
Also known as: Sodium heparin
Blood loss due to system coagulation during 4 weeks of hemodialysis
Evaluation of the change of the useful volume of the system below
Time frame: 4 weeks
Loss of venous capillary by clot formation during 4 weeks of hemodialysis
Absolut difference of dialyzer lost between the two groups of treatment in the 12 hemodialysis sessions
Time frame: 4 weeks
Change of the useful volume of the system in the dialyzer (priming of dialyzer)
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
Time frame: 4 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Eurofarma Laboratorios S.A.