Clincosm LogoSign in Get a demo

HEPIRC: UFH is the Most Used Anticoagulant in Hemodialysis, Decreasing the Risk of Clot Formation in the Circuit.

Sponsor
Eurofarma Laboratorios S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT05148377
Collaborator
(none)
128
Enrollment
2
Arms
16
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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:

  • Pharmacodynamic effect curve (activity) of heparin verified by dosing of TYPE and anti-Xa markers.

  • Effectiveness in maintaining blood coagulation during hemodialysis.

  • Blood loss by coagulation of the system;

  • Blood clotting and venous capillary loss;

  • Trunk of the capillary diolysor in the 12 follow-up sessions.

  • Safety in drug use through event monitoring complicating the use of heparin as:

  • Increased hematocrit of the patient;

  • Thrombocytopenia;

  • Bruise;

  • Fever;

  • Reactions to allergic agents;

Study Design

Study Type:
Interventional
Actual Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparin tested.Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparin tested.
Masking:
Double (Participant, Investigator)
Masking Description:
The pharmaceutical presentation of the medication to be studied is: solution for injection packaged in 5ml vial and 0.25ml ampoule. All doses have been prepared prior to administration to patients by the LAL Clinic Pharmacy which knows the randomization of the study. It is preparation consisted of preparing the dose of each patient previously calculated based on the weight of each patient and the pharmaceutical presentation of the product randomized into standard 3 ml syringes.
Primary Purpose:
Treatment
Official Title:
UFH is the Most Used Anticoagulant in Hemodialysis, Decreasing the Risk of Clot Formation in the Circuit.
Actual Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sodium heparin (Heptar)

Sodium heparin (Heptar®) produced by Eurofarma Laboratory,

Drug: Heptar
The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.
Other Names:
  • Sodium heparin

    		•
    Active Comparator: Liquemine®

    Roche Lab's Liquemine®

    Drug: Liquaemin
    The standardized dose for the study was 150UI / kg heparin. It was administered directly through the dialysis equipment.

    Outcome Measures

    Primary Outcome Measures

    1. Blood loss due to system coagulation during 4 weeks of hemodialysis [4 weeks]

      Evaluation of the change of the useful volume of the system below

    2. Loss of venous capillary by clot formation during 4 weeks of hemodialysis [4 weeks]

      Absolut difference of dialyzer lost between the two groups of treatment in the 12 hemodialysis sessions

    3. Change of the useful volume of the system in the dialyzer (priming of dialyzer) [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adults of both sexes, regardless of color or social class;

    • Age over 18 years, with good clinical characteristics at medical discretion;

    • Research patients who agree to participate in the study and sign the consent form free and informed;

    • Chronic renal failure patients on dialysis regimen (3 times a week).

    • Chronic Kidney Failure with indication for anticoagulant during dialysis

    Exclusion Criteria:

    • Not agreeing with the terms described in the informed consent;

    • Research patients with sensitivity to sadistic heparin;

    • Research patients with hypersensitivity to benzyl alcohol;

    • Research patients with a history of bleeding or disease that change in coagulation may worsen or terminate the clinical picture, such as ulcer gastric;

    • Research patients with a history of peptic ulcer.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Eurofarma Laboratorios S.A.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eurofarma Laboratorios S.A.
    ClinicalTrials.gov Identifier:
    NCT05148377
    Other Study ID Numbers:
    • EF101
    First Posted:
    Dec 8, 2021
    Last Update Posted:
    Dec 27, 2021
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heparin

    Study Results

    No Results Posted as of Dec 27, 2021