Renal InsufficiencyPhase 1NCT00413088
Study to Assess Bemiparin Pharmacokinetics in Renal Insufficiency and in the Elderly
A Phase 1 study testing bemiparin in people with Renal Insufficiency, run by Rovi Pharmaceuticals Laboratories at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- bemiparin
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2006to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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):
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital de la Santa Creu i Sant Pau and Fundació Puigvert
Barcelona, Barcelona, 08008
About this study
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
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
- Being tested
- bemiparin
- Keywords
- renal insufficency, low molecular weight heparin, pharmacokinetics, elderly
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bemiparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startMar 2006
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rovi Pharmaceuticals Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Manuel Barbanoj, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413088
- Sponsor's protocol ID
- ROV-BEM-2005-01
- Status last verified
- Mar 2011
- First submitted
- 14 Dec 2006
- Last updated
- 18 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00413088
- Acronym / sponsor ID
- ROV-BEM-2005-01
- Conditions
- Renal Insufficiency
- Keywords
- renal insufficency, low molecular weight heparin, pharmacokinetics, elderly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rovi Pharmaceuticals LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 19 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- Male or female subjects aged between 18 and 65 years, who will be assigned to one of the following groups according to renal function:
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bemiparin | Drug | – |
Primary outcome
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.
1 secondary outcome
To assess the safety and tolerability of bemiparin in all volunteers and patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Barbanoj, MD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bemiparin in people with Renal Insufficiency, run by Rovi Pharmaceuticals Laboratories at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2011.