Renal DialysisPhase 3MEMBRANENCT01179620
Certoparin in Renal Patients Undergoing Hemodialysis
A Phase 3 study testing Certoparin in people with Renal Dialysis, run by Novartis at 9 sites in Germany.
Trial summary
This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to prevent clotting during hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- Certoparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 9 sitesGermany
- Study dates
- Nov 2010to Mar 2011
- Phase
- Phase 3
- 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
- Patients requiring hemodialysis
- Patients requiring anticoagulation therapy during hemodialysis
- Written informed consent
Who cannot join
- Hypersensitivity to study medication
- Genetic abnormality or disease of clotting system
- Prior major surgery or bleeding
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Germany9 sites
Novartis Investigative Site Darmstadt
Darmstadt
Novartis Investigative Site Elsenfeld
Elsenfeld
Novartis Investigative Site Flensburg
Flensburg
Novartis Investigative Site Heringen
Heringen
Novartis Investigative Site Hoyerswerda,
Hoyerswerda
Novartis Investigative Site Kronach
Kronach
Novartis Investigative Site Magdeburg
Magdeburg
Novartis Investigative Site München
München
Novartis Investigative Site Münster
Münster
About this study
Official title: A Multi-center, Prospective, Open-label, 8-weeks Study to Investigate the Efficacy, Safety and Pharmacokinetics of Certoparin (3000 IU Anti-Xa Bolus, With the Option to Titrate Dose)in the Prophylaxis of Clotting in the Extracorporeal Circuit in Patients Undergoing Chronic Hemodialysis
This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to prevent clotting during hemodialysis.
- Conditions
- Renal Dialysis
- Being tested
- Certoparin
- Keywords
- Hemodialysis, Certoparin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CertoparinDrug
Certoparin
| Study group | Role | What they receive |
|---|---|---|
| Certoparin | Experimental | Not described Receives: Drug: Certoparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients requiring uptitration
Measured: Week 8
Secondary outcomes (2)
Pharmacokinetics of Certoparin
Measured: Day 1, Week 4
Safety and tolerability of Certoparin
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal DialysisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179620
- Sponsor's protocol ID
- CMEX839BDE06
- Acronym
- MEMBRANE
- Status last verified
- Jul 2012
- First submitted
- 27 Jul 2010
- Last updated
- 10 Jul 2012
- Results posted
- No
Publications
Dorsch O, Krieter DH, Lemke HD, Fischer S, Melzer N, Sieder C, Bramlage P, Harenberg J. A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis--the membrane study. BMC Nephrol. 2012 Jun 28;13:50. doi: 10.1186/1471-2369-13-50.
PubMed 22742742
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Open-label, 8-weeks Study to Investigate the Efficacy, Safety and Pharmacokinetics of Certoparin (3000 IU Anti-Xa Bolus, With the Option to Titrate Dose)in the Prophylaxis of Clotting in the Extracorporeal Circuit in Patients Undergoing Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT01179620
- Acronym / sponsor ID
- MEMBRANE / CMEX839BDE06
- Conditions
- Renal Dialysis
- Keywords
- Hemodialysis, Certoparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Aug 2010 (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.
This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to prevent clotting during hemodialysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Certoparin | Experimental | Drug: Certoparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients requiring hemodialysis
- Patients requiring anticoagulation therapy during hemodialysis
- Written informed consent
Key exclusion criteria (4 listed)
- Hypersensitivity to study medication
- Genetic abnormality or disease of clotting system
- Prior major surgery or bleeding
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| CertoparinCertoparin | Drug | Certoparin |
Primary outcome
Number of patients requiring uptitration
Time frame: Week 8
2 secondary outcomes
Pharmacokinetics of Certoparin
Time frame: Day 1, Week 4
Safety and tolerability of Certoparin
Time frame: 8 weeks
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 10 Jul 2012.
- Derived from this study: PubMed 22742742Dorsch O, Krieter DH, Lemke HD, Fischer S, Melzer N, Sieder C, Bramlage P, Harenberg J. A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis--the membrane study. BMC Nephrol. 2012 Jun 28;13:50. doi: 10.1186/1471-2369-13-50.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Certoparin in people with Renal Dialysis, run by Novartis at 9 sites in Germany.
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 3 inclusion and 4 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 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of patients requiring uptitration (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01179620, which also lists 1 linked publication.
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 10 Jul 2012.