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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014