NCT01034488 is a Phase 2/Phase 3 clinical trial of Suine in Pharmacodynamics, sponsored by Azidus Brasil.

Who is sponsoring NCT01034488?

NCT01034488 is sponsored by Azidus Brasil.

What drugs are being tested in NCT01034488?

Interventions in NCT01034488: Suine, Suine.

What condition does NCT01034488 study?

NCT01034488 studies Pharmacodynamics.

Is NCT01034488 still recruiting?

NCT01034488 is currently status unknown. Last updated 27 January 2011.

Last reviewed 2011-01-27 · How we verify

NCT01034488

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure

Status unknown Phase 2/Phase 3 Last updated 27 January 2011

What this trial tests

Phase 2/Phase 3 trial testing Suine in Pharmacodynamics in 128 participants. Status unknown.

Timeline

1 August 2010

Primary endpoint
1 December 2011

1 February 2012

Quick facts

Lead sponsor	Azidus Brasil
Phase	Phase 2/Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	128
Start date	1 August 2010
Primary completion	1 December 2011
Estimated completion	1 February 2012

Drugs / interventions tested

Suine — full drug profile →
Suine — full drug profile →

Conditions studied

Pharmacodynamics — all drugs for Pharmacodynamics →

Sponsor

Azidus Brasil — full company profile →

Who can join

18 and older, any sex, with Pharmacodynamics. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Effect (activity) of heparin observed for markers for aPTT and anti-Xa.
Time frame: 12 hemodialysis sessions in a row. The sessions take place 3 times a week. So be 4 weeks.

Sponsor's own description

1. Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. In addition, heparin and ATIII inactivate other proteases of the coagulation cascade, especially the anti-activated factor X. The outcome of these biochemical actions is the inhibition of the formation and synthesis of activators of the clotting factors that exert critical functions in the genesis of the blood clot. Patients with chronic renal failure (CRF) that make use of hemodialysis need a system of anticoagulation with direct inhibitors of thrombin and / or heparinoids to prevent thrombosis. Based on clinical studies, the control of plasma heparin level in patients with CRF is essential. Coagulation tests such as APTT, PT, ChT and evidence of activity of anti-Xa factor to be used as a substrate for protection for those patients undergoing hemodialysis. 2. Objective: Check the non-inferiority clinical, the pharmacodynamic effect and safety in use of the drug heparin of porcine origin, produced by the Laboratory Eurofarma, having as the active comparator drug APP ® Heparin Sodium (heparin - APP Pharmaceuticals) in patients with renal failure who do hemodialysis treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Pharmacodynamics

Currently open trials in the same condition.

NCT06469450 — KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts · Phase 1 · recruiting

Other Azidus Brasil trials

Trials by the same sponsor.

NCT06303635 — Safety of UFRJvac, Trivalent COVID-19 Vaccine · unknown
NCT06097780 — Efficacy and Safety of NestaCell® in Huntington's Disease · Phase 3 · unknown
NCT06150833 — Efficacy and Safety and Pharmacokinetics of Boya IVIG · Phase 3 · unknown
NCT05603403 — Efficacy And Safety Of Probiatop In The Treatment Of Digestive Symptoms · Phase 4 · completed
NCT05009277 — Study To Evaluate The Sensitivity Of The Linda Thermal Device · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01034488 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Azidus Brasil
Last refreshed: 27 January 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01034488.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing