Study to Assess Bemiparin Pharmacokinetics in Renal Insufficiency and in the Elderly

This study has been completed.
Sponsor:
Information provided by:
Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier:
NCT00413088
First received: December 14, 2006
Last updated: March 17, 2011
Last verified: March 2011
  Purpose

Open pharmacokinetic study with 5 parallel groups and two treatment phases (bemiparin 3,500 IU multiple dose and bemiparin 115 IU/kg single dose). The bemiparin pharmacokinetic profile will be assessed by measuring its effects on the coagulation cascade. Plasma anti-Xa activity (measured using chromogenic amidolytic assay) in IU per milliliter will be the primary endpoint to assess the pharmacokinetic profile of bemiparin.


Condition Intervention Phase
Renal Insufficiency
Drug: bemiparin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial to Assess Bemiparin Pharmacokinetics at Therapeutic (115 IU/kg) and Prophylactic Doses (3500 IU) Administered Subcutaneously in Single or Multiple Doses in Renal Insufficiency and in the Elderly

Resource links provided by NLM:


Further study details as provided by Rovi Pharmaceuticals Laboratories:

Primary Outcome Measures:
  • To assess the pharmacokinetics of bemiparin administered subcutaneously once daily for 4 days at prophylactic doses (3500 IU) and at a single therapeutic dose (115 IU/kg), in renal insufficiency and in the elderly.

Secondary Outcome Measures:
  • To assess the safety and tolerability of bemiparin in all volunteers and patients.

Estimated Enrollment: 60
Study Start Date: March 2006
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Non-elderly healthy volunteers (Group I):

  • Male or female subjects aged between 18 and 65 years
  • body weight, clinical history, physical examination, vital signs (systolic and diastolic blood pressure, heart beat rate and body temperature), ECG and laboratory tests (hemogram and biochemistry) within normal range
  • without evidence of significant organic or psychiatric illness
  • who have accepted to participate in the study and have signed the written informed consent.

Patients with renal insufficiency (Groups II, III and IV):

  • Male or female subjects aged between 18 and 65 years, who will be assigned to one of the following groups according to renal function:

    • Group II: mild renal insufficiency (creatinine clearance > 50 to 80 ml/min);
    • Group III: Moderate renal insufficiency (creatinine clearance: 30 to 50 ml/min);
    • Group IV: Severe renal insufficiency (creatinine clearance < 30 ml/min). The degree of renal insufficiency will be calculated on the basis of determination of creatinine clearance measuring total urinary output over a 24-h period and serum creatinine levels. Urine samples will be collected no more than 2 weeks before the first experimental period.
  • Patients with renal insufficiency must have a stable renal function during the 3 months before their inclusion in the study.
  • They must have a body weight between 45 and 110 Kg.
  • They have to accept to participate in the study and have signed the written informed consent.

Elderly healthy volunteers (Group V):

  • Male or female subjects aged > 65 years old who fulfill with the remaining inclusion criteria specified for non-elderly healthy volunteers.

Exclusion Criteria:

Non-elderly healthy volunteers (Group I):

  • Previous history of alcoholism or drugs consumption
  • Important consumer of exciting drinks
  • Hypersensitivity, allergy, idiosyncrasy to medicines
  • Taking another medication four weeks before the initiation of the trial including medication without prescription and medicinal plants
  • Positive serology of hepatitis B, C or HIV virus
  • History or clinic evidence of concomitant disease
  • Familiar history of coagulation's disorders
  • surgery within the previous 6 months
  • Women who are pregnant or who are not using effective contra conceptive methods
  • Ethanol, cannabis, cocaine, amphetamine, benzodiazepin or opiate in urine
  • Current platelet count < 100.000/mm3 or serum K > 5,5 mEq/L
  • Any contraindication to bemiparin administration in order to authorized summary product characteristics
  • Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
  • To give blood in the four weeks before beginning of the trial

Patients with renal insufficiency or elderly healthy volunteers (Groups II, III, IV, V):

  • Previous history of alcoholism or drugs consumption
  • Important consumer of exciting drinks
  • Hypersensitivity, allergy, idiosyncrasy to medicines
  • Treatment with enzymatic inhibitors or inductors medicines
  • Administration with ASA of dosis > 125 mg/day and/or NDAIs with half-life > 20 hours or with high antiagregant effect during the previous ten days to the inclusion
  • Chronic hepatopatology
  • bilirubin levels > 1,5 mg/dl and/or increment of AST/ALT levels twice higher than maximum limit of normality
  • prothrombin time 20% higher than maximun limit of normality and haemoglobine < 8gr/dl or albumim levels <3gr/dl
  • Previous history of acute infarction of myocardium, cardiac ischemic or arrhythmia
  • Acute illness in the previous week to the participation
  • Familiar history of coagulation's disorders
  • surgery within the previous 6 months
  • Women who are pregnant or who are not using effective contra conceptive methods
  • Ethanol, cannabis, cocaine, amphetamine, benzodiazepin or opiate in urine
  • Current platelet count < 75.000/mm3 or serum K > 6 mEq/L
  • Any contraindication to bemiparin administration in order to authorized summary product characteristics
  • Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
  • To give blood in the four weeks before beginning of the trial
  • Subjects in haemodialysis or peritoneal dialysis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413088

Locations
Spain
Hospital de la Santa Creu i Sant Pau and Fundació Puigvert
Barcelona, Spain, 08008
Sponsors and Collaborators
Rovi Pharmaceuticals Laboratories
Investigators
Principal Investigator: Manuel Barbanoj, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

Responsible Party: Medical Deparment, Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier: NCT00413088     History of Changes
Other Study ID Numbers: ROV-BEM-2005-01
Study First Received: December 14, 2006
Last Updated: March 17, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Rovi Pharmaceuticals Laboratories:
renal insufficency
low molecular weight heparin
pharmacokinetics
elderly

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 21, 2014