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

Renal Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413088
• Other study ID #: ROV-BEM-2005-01
• Status: Completed
• Phase: Phase 1
• First received: December 14, 2006
• Last updated: March 17, 2011
• Start date: March 2006
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: Rovi Pharmaceuticals Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• bemiparin

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau and Fundació Puigvert	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Rovi Pharmaceuticals Laboratories

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess the safety and tolerability of bemiparin in all volunteers and patients.