Status:
COMPLETED
Study to Assess Bemiparin Pharmacokinetics in Renal Insufficiency and in the Elderly
Lead Sponsor:
Rovi Pharmaceuticals Laboratories
Conditions:
Renal Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 assesse...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00413088
Start Date
March 1 2006
End Date
March 1 2011
Last Update
March 18 2011
Active Locations (1)
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1
Hospital de la Santa Creu i Sant Pau and Fundació Puigvert
Barcelona, Barcelona, Spain, 08008