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

NCT00413088 | Completed Phase 1

• 1 other identifier: ROV-BEM-2005-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Renal Insufficiency

Keywords

renal insufficency; low molecular weight heparin; pharmacokinetics; elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To assess the safety and tolerability of bemiparin in all volunteers and patients.

Interventions

bemiparin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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):

You may not qualify if:

• 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

Sponsors & Collaborators

• Rovi Pharmaceuticals Laboratories: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau and Fundació Puigvert

Barcelona, Barcelona, 08008, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

bemiparin

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Manuel Barbanoj, MD

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 14, 2006
• First Posted: December 19, 2006
• Study Start: March 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 18, 2011

Record last verified: 2011-03

Locations

ES (1)