InflammationNCT00135863
MesoHep II: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis
A study testing tinzaparin in people with Inflammation and Nutrition, run by Ribe County Hospital at 1 site in Denmark.
Trial summary
Patients with end stage renal disease (ESRD) who use peritoneal dialyses with Physioneal(R) (Baxter A/S, Denmark) were allocated to inject either placebo or tinzaparin daily into the morning dialysis bag. Active medication, as well as placebo, was added for three months separated by a one month washout period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Nutrition, Peritoneal Dialysis
- What is being tested?
- tinzaparin
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- May 2004to May 2005
- Phase
- Interventional
- 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
Who may be able to join
- End stage renal disease
- Peritoneal dialysis without complication for minimum of three months
- 18 years or above
- Informed consent
Who cannot join
- Known coagulatory defects including anticoagulation therapy
- Known bleeding tendency
- Peritonitis within two months prior to inclusion
- Pregnancy
- Breast feeding
- Active infection
- Non-informed consent
- Allergy to heparin or prior heparin induced thrombocytopenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis
Patients with end stage renal disease (ESRD) who use peritoneal dialyses with Physioneal(R) (Baxter A/S, Denmark) were allocated to inject either placebo or tinzaparin daily into the morning dialysis bag. Active medication, as well as placebo, was added for three months separated by a one month washout period. At the beginning and end of each treatment period peritoneal equilibrations tests (PE-tests), Kt/V, blood and dialysate samples were analyzed. We, the researchers at Ribe County Hospital, set out to examine inflammation (local and systemic), nutrition and ultrafiltration.
- Conditions
- Inflammation, Nutrition, Peritoneal Dialysis
- Being tested
- tinzaparin
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tinzaparinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of inflammation, local and systemic
Secondary outcomes (5)
Vascular compliance
Nutritional state
Efficacy of Peritoneal Dialysis
Change in local cellular distribution
Change in local and systemic generation of thrombi
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startMay 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 36 participants
Sponsor and investigators
- Lead sponsor
- Ribe County Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma, Coloplast A/S
- Investigators
- Robert S Petersen, MD, Study chair, Ribe County Hospital, Department of NephrologyMikkel B Rasmussen, MD, Principal investigator, Ribe County Hospital, Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135863
- Sponsor's protocol ID
- MesoHep II
- Other IDs
- 2564-03, 2612-2459
- Status last verified
- Jan 2004
- First submitted
- 25 Aug 2005
- Last updated
- 21 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Low Molecular Weight Heparin in Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT00135863
- Acronym / sponsor ID
- MesoHep II
- Conditions
- Inflammation, Nutrition, Peritoneal Dialysis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants
- Lead sponsor
- Ribe County HospitalUniversity, hospital or other
- Collaborators
- LEO Pharma, Coloplast A/S
- Study start
- May 2004
- Study completion
- May 2005
- First posted
- 26 Aug 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.
Patients with end stage renal disease (ESRD) who use peritoneal dialyses with Physioneal(R) (Baxter A/S, Denmark) were allocated to inject either placebo or tinzaparin daily into the morning dialysis bag. Active medication, as well as placebo, was added for three months separated by a one month washout period. At the beginning and end of each treatment period peritoneal equilibrations tests (PE-tests), Kt/V, blood and dialysate samples were analyzed. We, the researchers at Ribe County Hospital, set out to examine inflammation (local and systemic), nutrition and ultrafiltration.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- End stage renal disease
- Peritoneal dialysis without complication for minimum of three months
- 18 years or above
- Informed consent
Key exclusion criteria (8 listed)
- Known coagulatory defects including anticoagulation therapy
- Known bleeding tendency
- Peritonitis within two months prior to inclusion
- Pregnancy
- Breast feeding
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 |
|---|---|---|
| tinzaparin | Drug | – |
Primary outcome
Grade of inflammation, local and systemic
5 secondary outcomes
Vascular compliance
Nutritional state
Efficacy of Peritoneal Dialysis
Change in local cellular distribution
Change in local and systemic generation of thrombi
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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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.
Robert S Petersen, MD study chair
Ribe County Hospital, Department of Nephrology
Mikkel B Rasmussen, MD principal investigator
Ribe County Hospital, Department of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tinzaparin in people with Inflammation and Nutrition, run by Ribe County Hospital at 1 site in Denmark.
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: stopped early, as of the sponsor's last update on 21 May 2015. 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 Denmark. 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 was stopped early. Results are not available in the source record.
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?
Grade of inflammation, local and systemic. 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 21 May 2015.