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

NCT05148377 | Completed Phase 3 DMC

• 1 other identifier: EF101
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (3)

• Blood loss due to system coagulation during 4 weeks of hemodialysis

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

  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

  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

  4 weeks

Study Arms (2)

Sodium heparin (Heptar)

EXPERIMENTAL

Sodium heparin (Heptar®) produced by Eurofarma Laboratory,

Drug: Heptar

Liquemine®

ACTIVE COMPARATOR

Roche Lab's Liquemine®

Drug: Liquaemin

Interventions

Liquaemin DRUG

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

Liquemine®

Heptar DRUG

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

Also known as: Sodium heparin

Sodium heparin (Heptar)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel clinical study, randomized, double-blind, systematic sampling that evaluated the safety of the sadistic Heparin tested.

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: December 8, 2021
• Study Start: August 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 27, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share