Renal InsufficiencyNCT00264693
Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function
An observational study of Renal Insufficiency, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
Low molecular weight heparins (LMWH) have been shown to be at least as efficient and safe as unfractioned heparin (UFH) in prophylaxis and treatment of venous thromboembolic events and in therapy of acute cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency
- How many people
- 96 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2006to May 2008
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients of a medical and surcigal department with all levels of renal function who needs Dalteparin for prophylaxis or therapy.
Who may be able to join
- Patient starting with dalteparin for prophylaxis OR therapy by order of the treating physician (after having evaluated clinical indication and contraindications).
- Renal function normal OR impaired with or without dialysis therapy according to open study groups
- Age >= 18 years
- Written informed consent
Who cannot join
- Pregnancy / Lactation
- Dalteparin or other LMWH already in use for > 1 day, unless just in use during hemodialysis
- Anti-Xa level before first application of dalteparin > 0.3 U / ml
- Participation in another study
- Anuria OR glomerular filtration rate < 10 ml/min without dialysis
- Patient on intensive care unit (ICU)
- Cardiovascular unstable patient or probable need for a quick stop of anticoagulation (e.g. emergency surgery)
- Patient with a disease whose estimated life expectancy is < 28 days
Trial locations and contacts
1 site in 1 country.
About this study
Low molecular weight heparins (LMWH) have been shown to be at least as efficient and safe as unfractioned heparin (UFH) in prophylaxis and treatment of venous thromboembolic events and in therapy of acute cardiovascular diseases. LMWH are widely used as safe replacement of oral anticoagulation with vitamin K antagonists (VKA).
Due to their pharmacokinetic characteristics, LMWH tend to accumulate in patients with impaired renal function. Official guidelines recommend therefore to use LMWH controlled by Anti-Xa levels or to use UFH instead of LMWH to provide full therapeutic anticoagulation therapy in patients with severe renal insufficiency.
Read more
Although dosage recommendations have been proposed for enoxaparin in patients with renal impairment based on several studies, these data cannot be applied to other LMWH directly due to different pharmacokinetic properties of each drug.
The present study aims to clarify the pharmacokinetics of dalteparin in patients with renal insufficiency, especially addressing the question of accumulation after multiple doses and including patients with severe renal insufficiency and derive a safe and suitable concept for using dalteparin in patients with impaired renal function.
- Conditions
- Renal Insufficiency
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| P - A | Prophylactic Dosage, GFR >= 60 mL/min/1.73m^2 | |
| P - B | Prophylactic Dosage, GFR 30-59 mL/min/1.73m^2 | |
| P - C | Prophylactic Dosage, GFR < 30 mL/min/1.73m^2 | |
| P - CAPD | Prophylactic Dosage, CAPD | |
| T - A | Therapeutic Dosage, GFR >= 60 mL/min/1.73m^2 | |
| T - B | Therapeutic Dosage, GFR 30-59 mL/min/1.73m^2 | |
| T - C | Therapeutic Dosage, GFR < 30 mL/min/1.73m^2 | |
| T - CAPD | Therapeutic Dosage, CAPD |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Pirmin Schmid, MD, Principal investigator, Luzerner Kantonsspital, HematologyAndreas G Fischer, MD, Study director, Luzerner Kantonsspital, NephrologyWalter A Wuillemin, MD, PhD, Study chair, Luzerner Kantonsspital, Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264693
- Sponsor's protocol ID
- LMWHplus 3
- Other IDs
- Ethikkommission Luzern 542, KSL 2006-1H
- Status last verified
- Aug 2009
- First submitted
- 11 Dec 2005
- Last updated
- 26 Jan 2010
- Results posted
- No
Publications
Schmid P, Fischer AG, Wuillemin WA. Low-molecular-weight heparin in patients with renal insufficiency. Swiss Med Wkly. 2009 Aug 8;139(31-32):438-52. doi: 10.4414/smw.2009.11284.
PubMed 19685350Schmid P, Brodmann D, Fischer AG, Wuillemin WA. Study of bioaccumulation of dalteparin at a prophylactic dose in patients with various degrees of impaired renal function. J Thromb Haemost. 2009 Apr;7(4):552-8. doi: 10.1111/j.1538-7836.2009.03292.x. Epub 2009 Jan 19.
PubMed 19175499Schmid P, Brodmann D, Odermatt Y, Fischer AG, Wuillemin WA. Study of bioaccumulation of dalteparin at a therapeutic dose in patients with renal insufficiency. J Thromb Haemost. 2009 Oct;7(10):1629-32. doi: 10.1111/j.1538-7836.2009.03556.x. Epub 2009 Jul 17.
PubMed 19624460Schmid P, Brodmann D, Fischer AG, Wuillemin WA. Prospective observational cohort study of bioaccumulation of dalteparin at a prophylactic dose in patients with peritoneal dialysis. J Thromb Haemost. 2010 Apr;8(4):850-2. doi: 10.1111/j.1538-7836.2010.03749.x. Epub 2010 Jan 17. No abstract available.
PubMed 20088934
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT00264693
- Acronym / sponsor ID
- LMWHplus 3
- Conditions
- Renal Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jan 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 13 Dec 2005 (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.
Low molecular weight heparins (LMWH) have been shown to be at least as efficient and safe as unfractioned heparin (UFH) in prophylaxis and treatment of venous thromboembolic events and in therapy of acute cardiovascular diseases. LMWH are widely used as safe replacement of oral anticoagulation with vitamin K antagonists (VKA).
Due to their pharmacokinetic characteristics, LMWH tend to accumulate in patients with impaired renal function. Official guidelines recommend therefore to use LMWH controlled by Anti-Xa levels or to use UFH instead of LMWH to provide full therapeutic anticoagulation therapy in patients with severe renal insufficiency.
Although dosage recommendations have been proposed for enoxaparin in patients with renal impairment based on several studies, these data cannot be applied to other LMWH directly due to different pharmacokinetic properties of each drug.
The present study aims to clarify the pharmacokinetics of dalteparin in patients with renal insufficiency, especially addressing the question of accumulation after multiple doses and including patients with severe renal insufficiency and derive a safe and suitable concept for using dalteparin in patients with impaired renal function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| P - A | – | –Prophylactic Dosage, GFR >= 60 mL/min/1.73m^2 |
| P - B | – | –Prophylactic Dosage, GFR 30-59 mL/min/1.73m^2 |
| P - C | – | –Prophylactic Dosage, GFR < 30 mL/min/1.73m^2 |
| P - CAPD | – | –Prophylactic Dosage, CAPD |
| T - A | – | –Therapeutic Dosage, GFR >= 60 mL/min/1.73m^2 |
| T - B | – | –Therapeutic Dosage, GFR 30-59 mL/min/1.73m^2 |
| T - C | – | –Therapeutic Dosage, GFR < 30 mL/min/1.73m^2 |
| T - CAPD | – | –Therapeutic Dosage, CAPD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of a medical and surcigal department with all levels of renal function who needs Dalteparin for prophylaxis or therapy.
Key inclusion criteria (4 listed)
- Patient starting with dalteparin for prophylaxis OR therapy by order of the treating physician (after having evaluated clinical indication and contraindications).
- Renal function normal OR impaired with or without dialysis therapy according to open study groups
- Age >= 18 years
- Written informed consent
Key exclusion criteria (8 listed)
- Pregnancy / Lactation
- Dalteparin or other LMWH already in use for > 1 day, unless just in use during hemodialysis
- Anti-Xa level before first application of dalteparin > 0.3 U / ml
- Participation in another study
- Anuria OR glomerular filtration rate < 10 ml/min without dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 26 Jan 2010.
- Background: PubMed 19685350Schmid P, Fischer AG, Wuillemin WA. Low-molecular-weight heparin in patients with renal insufficiency. Swiss Med Wkly. 2009 Aug 8;139(31-32):438-52. doi: 10.4414/smw.2009.11284.
- Results publication: PubMed 19175499Schmid P, Brodmann D, Fischer AG, Wuillemin WA. Study of bioaccumulation of dalteparin at a prophylactic dose in patients with various degrees of impaired renal function. J Thromb Haemost. 2009 Apr;7(4):552-8. doi: 10.1111/j.1538-7836.2009.03292.x. Epub 2009 Jan 19.
- Results publication: PubMed 19624460Schmid P, Brodmann D, Odermatt Y, Fischer AG, Wuillemin WA. Study of bioaccumulation of dalteparin at a therapeutic dose in patients with renal insufficiency. J Thromb Haemost. 2009 Oct;7(10):1629-32. doi: 10.1111/j.1538-7836.2009.03556.x. Epub 2009 Jul 17.
- Results publication: PubMed 20088934Schmid P, Brodmann D, Fischer AG, Wuillemin WA. Prospective observational cohort study of bioaccumulation of dalteparin at a prophylactic dose in patients with peritoneal dialysis. J Thromb Haemost. 2010 Apr;8(4):850-2. doi: 10.1111/j.1538-7836.2010.03749.x. Epub 2010 Jan 17. No abstract available.
- Luzerner Kantonsspital, HematologyLink provided by the sponsor.
- Luzerner Kantonsspital, NephrologyLink provided by the sponsor.
- Pirmin SchmidLink provided by the sponsor.
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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.
Pirmin Schmid, MD principal investigator
Luzerner Kantonsspital, Hematology
Andreas G Fischer, MD study director
Luzerner Kantonsspital, Nephrology
Walter A Wuillemin, MD, PhD study chair
Luzerner Kantonsspital, Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency, run by Luzerner Kantonsspital at 1 site in Switzerland.
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 4 inclusion and 8 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 26 Jan 2010. 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 Switzerland. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00264693, which also lists 4 linked publications.
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 26 Jan 2010.