HaemodialysisPhase 2NCT01382888
Efficacy and Local Tolerability of Topically Applied Heparin on the Suitability of Newly Constructed Primary Arteriovenous Fistulas in Patients Planned for Haemodialysis
A Phase 2 study testing Heparin 2,400 IU /ml Cutaneous Spray in people with Haemodialysis, run by Cyathus Exquirere Pharmaforschungsgmbh at 3 sites in Austria.
Trial summary
The primary objective of this study is to evaluate the effect of topically applied heparin in comparison to placebo on suitability of newly constructed primary arteriovenous fistulas in patients planned for haemodialysis at 7th week (± 1 week) after first study drug administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodialysis
- What is being tested?
- Heparin 2,400 IU /ml Cutaneous Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesAustria
- Study dates
- Jul 2011to Apr 2014
- Phase
- Phase 2
- 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
- Male and/or female outpatients
- Aged over 18 years
- Stage 4 or 5 Chronic kidney Disease according to KDOQI classification
- Surgery to create an arteriovenous fistula in the lower arm is planned
- If female of childbearing potential: agree to maintain reliable birth control throughout the study and negative (urine) pregnancy test
Who cannot join
- Known hypersensitivity to any component of the study medication
- History of previous arm (side of planned AVF), neck, or chest surgery/trauma
- Anticipated kidney transplant from living donor within the next 3 months
- Presence of any comorbidity that limits patient's life expectancy to less than 6 months.
- Pregnancy / lactation or intention to fall pregnant during the time course of the study and women of childbearing potential who are not using adequate contraception
- Known bleeding disorder or established diagnosis of active or suspected bleeding
- Platelet count less than 80 x 10^9/L
- Uncontrolled hypertension: Diastolic blood pressure > 115 mm Hg or Systolic blood pressure > 200 mm Hg
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
Krankenhaus der Elisabethinen Linz
Linz, 4020
Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie und Dialyse, Medizinische Universität Wien
Vienna, State of Vienna, 1090
6. Medizinische Abteilung mit Nephrologie und Dialyse, Wilhelminenspital Wien
Vienna, State of Vienna, 1160
About this study
Official title: Efficacy and Local Tolerability of Topically Applied Heparin (Heparin 2,400 IU /ml Cutaneous Spray) on the Suitability of Newly Constructed Primary Arteriovenous Fistulas in Patients Planned for Haemodialysis. A Multicentre, Randomized, Double-blind and Placebo-controlled Pilot Study
The primary objective of this study is to evaluate the effect of topically applied heparin in comparison to placebo on suitability of newly constructed primary arteriovenous fistulas in patients planned for haemodialysis at 7th week (± 1 week) after first study drug administration.
Read the detailed description
The clinical dilemma surrounding the maturation and suitability of the AVF in patients undergoing hemodialysis suggests the requirement for a medication that can be added to the standard therapy with in order to help maturation and suitability of newly created AVF. Numerous research papers published over the past 25 years indicate that heparin might have a positive impact on main factors involved in the early failure of native AVF to mature.
In total 56 eligible patients will be enrolled after giving informed consent. Screening will take place in the preceding 6 weeks before scheduled AVF creation. Only patients receiving a Brescia - Cimino (radio - cephalic) fistula or a distal ulnar artery to basilica vein, proximal radial artery to transposed basilica vein, brachial artery to transposed basilica vein and brachial artery to cephalic vein will later be randomized. Patients will be randomly assigned in equal proportions (each group 28 patients) to receive either topically applied heparin (Heparin 2,400 IU /ml Cutaneous Spray) or placebo using a computer-generated randomization. Participants and members of the study team will be blinded to treatment assignment. Patients will be instructed how to use and administer study medication for the consecutive 24 weeks following randomization.
Assessment of the primary endpoint (suitability of newly constructed primary arteriovenous fistulas) is done at 7th week (± 1 week) after first study drug administration. The suitability and unassisted patency and local safety and tolerability by physician and patient of the AVF will also be determined at 12 weeks (± 1 week) and 24 weeks (± 1 week) after first study drug administration. Administration of study medication will be stopped at week 24 after randomization.
- Conditions
- Haemodialysis
- Being tested
- Heparin 2,400 IU /ml Cutaneous Spray, Placebo Cutaneous Spray
- Keywords
- Haemodialysis, Arteriovenous fistula, Severe chronic kidney disease, Newly constructed primary arteriovenous fistulas in patients planned for haemodialysis
- Medical subject headings
- Arteriovenous Fistula, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin 2,400 IU /ml Cutaneous SprayDrug
Randomization will be performed 2 - 14 days post fistula creation surgery following confirmation that the fistula is patent by physical examination. Patients that are randomized to this study arm, will be asked to administer the study medication twice daily. Patients will get adequate training before first administration.
Placebo Cutaneous SprayDrug
Randomization will be performed 2 - 14 days post fistula creation surgery following confirmation that the fistula is patent by physical examination. Patients that are randomized to this study arm, will be asked to administer the study medication (placebo) twice daily. Patients will get adequate training before first administration.
| Study group | Role | What they receive |
|---|---|---|
| Heparin 2,400 IU /ml Cutaneous Spray | Active comparator | Patients are randomized to receive the active comparator heparin 2,400 IU/ml cutaneous spray for 24 weeks Receives: Drug: Heparin 2,400 IU /ml Cutaneous Spray |
| Placebo Cutaneous Spray | Placebo comparator | Patients are randomized to receive placebo cutaneous spray for 24 weeks Receives: Drug: Placebo Cutaneous Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis with a blood flow rate ≥ 300 ml/min OR, if the patient is not in need of dialysis, by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression
Primary outcome measure is the suitability of the AVF (dialysis with a blood flow rate ≥ 300 ml/min ) at 7th week (± 1 week) after first study drug administration. Suitability of the AVF will be assessed by using the AVF for dialysis. If a flow rate of at least 300 ml/min can be reached for at least 3 minutes suitability is fulfilled.If the patient is not in need of dialysis, suitability will be assessed by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression
Measured: 7 ± 1 week
Secondary outcomes (3)
Dialysis with a blood flow rate ≥ 300mL/min. If the patient is not in need of dialysis, by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression.
The suitability of the AVF (dialysis with a blood flow rate ≥ 300mL/min) at 12th and 24th week after first study drug administration. If a flow rate of at least 300 ml/min can be reached for at least 3 minutes suitability is fulfilled. If the patient is not in need of dialysis, the suitability will be assessed by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression.
Measured: at 12th and 24th week after first study drug administration
The functional (unassisted) patency of AVF
Unassisted patency of the AVF will be assessed by palpation and auscultation for at least 30 seconds.
Measured: at 7th, 12th and 24th weeks after first study drug administration
Local safety and tolerability profile of IMP by patients and investigator (Global assessment of tolerability)
A scale will be used to assess local tolerability. In addition the investigator will screen for known heparin specific reactions, i.e. skin rash and skin swelling.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: The Sponsor decided to terminate the study due to the low patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemodialysisStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyathus Exquirere Pharmaforschungsgmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382888
- Sponsor's protocol ID
- CYT/Heparin - 01/11
- Other IDs
- 2011-000455-16
- Status last verified
- May 2014
- First submitted
- 24 Jun 2011
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Local Tolerability of Topically Applied Heparin (Heparin 2,400 IU /ml Cutaneous Spray) on the Suitability of Newly Constructed Primary Arteriovenous Fistulas in Patients Planned for Haemodialysis. A Multicentre, Randomized, Double-blind and Placebo-controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01382888
- Acronym / sponsor ID
- CYT/Heparin - 01/11
- Conditions
- Haemodialysis
- Keywords
- Haemodialysis, Arteriovenous fistula, Severe chronic kidney disease, Newly constructed primary arteriovenous fistulas in patients planned for haemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor decided to terminate the study due to the low patient recruitment.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cyathus Exquirere PharmaforschungsgmbhIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Jun 2011 (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.
The primary objective of this study is to evaluate the effect of topically applied heparin in comparison to placebo on suitability of newly constructed primary arteriovenous fistulas in patients planned for haemodialysis at 7th week (± 1 week) after first study drug administration.
Detailed description
The clinical dilemma surrounding the maturation and suitability of the AVF in patients undergoing hemodialysis suggests the requirement for a medication that can be added to the standard therapy with in order to help maturation and suitability of newly created AVF. Numerous research papers published over the past 25 years indicate that heparin might have a positive impact on main factors involved in the early failure of native AVF to mature.
In total 56 eligible patients will be enrolled after giving informed consent. Screening will take place in the preceding 6 weeks before scheduled AVF creation. Only patients receiving a Brescia - Cimino (radio - cephalic) fistula or a distal ulnar artery to basilica vein, proximal radial artery to transposed basilica vein, brachial artery to transposed basilica vein and brachial artery to cephalic vein will later be randomized. Patients will be randomly assigned in equal proportions (each group 28 patients) to receive either topically applied heparin (Heparin 2,400 IU /ml Cutaneous Spray) or placebo using a computer-generated randomization. Participants and members of the study team will be blinded to treatment assignment. Patients will be instructed how to use and administer study medication for the consecutive 24 weeks following randomization.
Assessment of the primary endpoint (suitability of newly constructed primary arteriovenous fistulas) is done at 7th week (± 1 week) after first study drug administration. The suitability and unassisted patency and local safety and tolerability by physician and patient of the AVF will also be determined at 12 weeks (± 1 week) and 24 weeks (± 1 week) after first study drug administration. Administration of study medication will be stopped at week 24 after randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin 2,400 IU /ml Cutaneous Spray | Active comparator | Drug: Heparin 2,400 IU /ml Cutaneous SprayPatients are randomized to receive the active comparator heparin 2,400 IU/ml cutaneous spray for 24 weeks |
| Placebo Cutaneous Spray | Placebo comparator | Drug: Placebo Cutaneous SprayPatients are randomized to receive placebo cutaneous spray for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and/or female outpatients
- Aged over 18 years
- Stage 4 or 5 Chronic kidney Disease according to KDOQI classification
- Surgery to create an arteriovenous fistula in the lower arm is planned
- If female of childbearing potential: agree to maintain reliable birth control throughout the study and negative (urine) pregnancy test
Key exclusion criteria (8 listed)
- Known hypersensitivity to any component of the study medication
- History of previous arm (side of planned AVF), neck, or chest surgery/trauma
- Anticipated kidney transplant from living donor within the next 3 months
- Presence of any comorbidity that limits patient's life expectancy to less than 6 months.
- Pregnancy / lactation or intention to fall pregnant during the time course of the study and women of childbearing potential who are not using adequate contraception
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 |
|---|---|---|
| Heparin 2,400 IU /ml Cutaneous SprayRandomization will be performed 2 - 14 days post fistula creation surgery following confirmation that the fistula is patent by physical examination. Patients that are randomized to this study arm, will be asked to administer the study medication twice daily. Patients will get adequate training before first administration. | Drug | Heparin 2,400 IU /ml Cutaneous Spray |
| Placebo Cutaneous SprayRandomization will be performed 2 - 14 days post fistula creation surgery following confirmation that the fistula is patent by physical examination. Patients that are randomized to this study arm, will be asked to administer the study medication (placebo) twice daily. Patients will get adequate training before first administration. | Drug | Placebo Cutaneous Spray |
Primary outcome
Dialysis with a blood flow rate ≥ 300 ml/min OR, if the patient is not in need of dialysis, by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression
Time frame: 7 ± 1 week
Primary outcome measure is the suitability of the AVF (dialysis with a blood flow rate ≥ 300 ml/min ) at 7th week (± 1 week) after first study drug administration. Suitability of the AVF will be assessed by using the AVF for dialysis. If a flow rate of at least 300 ml/min can be reached for at least 3 minutes suitability is fulfilled.If the patient is not in need of dialysis, suitability will be assessed by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression
3 secondary outcomes
Dialysis with a blood flow rate ≥ 300mL/min. If the patient is not in need of dialysis, by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression.
Time frame: at 12th and 24th week after first study drug administration
The functional (unassisted) patency of AVF
Time frame: at 7th, 12th and 24th weeks after first study drug administration
Local safety and tolerability profile of IMP by patients and investigator (Global assessment of tolerability)
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: The Sponsor decided to terminate the study due to the low patient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Heparin 2,400 IU /ml Cutaneous Spray in people with Haemodialysis, run by Cyathus Exquirere Pharmaforschungsgmbh at 3 sites in Austria.
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 5 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: The Sponsor decided to terminate the study due to the low patient recruitment.). 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?
Dialysis with a blood flow rate ≥ 300 ml/min OR, if the patient is not in need of dialysis, by combining the venous diameter > 0.4 cm and flow volume > 500ml/min assessed by duplex ultrasound, as well as via clinical impression (time frame: 7 ± 1 week). 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 8 May 2014.