Renal DialysisPhase 2LIPMATNCT02495662
The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation
A Phase 2 study testing PEG-liposomal prednisolone sodium phosphate in people with Renal Dialysis and Hemodynamics, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
This study will investigate if liposomal prednisolone is effective in promoting arteriovenous fistula (AVF) maturation when administered to human subjects after surgical creation of a radio-cephalic AVF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Dialysis, Hemodynamics, Vascular Remodeling
- What is being tested?
- PEG-liposomal prednisolone sodium phosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2015to 30 May 2018
- 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
- Patients who are scheduled for creation of a radiocephalic AVF for maintenance hemodialysis.
- Male or female ≥ 18 years old.
- Patients are able and willing to give written informed consent.
Who cannot join
- Any concurrent illness, disability or clinically significant abnormality that may, as judged by the investigator, affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol.
- Current participation in another interventional clinical trial or subjects who have received an investigational drug within 30 days prior to the baseline visit.
- History of psychosis.
- History of osteonecrosis
- Previous AVF in the ipsilateral arm.
- Current central venous catheter at the ipsilateral side.
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- Treatment with oral, rectal or injectable (including intra-articular) glucocorticoids (CS) within 6 weeks prior to baseline visit. Inhaled glucocorticoids are allowed. Topical steroids are allowed, however subjects should not have received more than 100 gram of a mild to moderate topical corticosteroid cream per week, 50 gram of a potent corticosteroid cream per week or 30 gram of a very potent topical corticosteroid cream per week in the 4 weeks prior to the baseline visit.
- Treatment with immunosuppressant drugs. Treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
- Patients who are unlikely to adequately comply with the trial's procedures (due for instance to medical conditions likely to require an extended interruption or discontinuation, history of substance abuse or noncompliance).
- Women who are lactating, pregnant (positive pregnancy test at baseline) or planning to become pregnant during the course of the study.
- Unwillingness to use reliable and acceptable contraceptive methods throughout the study and till 3 months after last study medication except for female patients who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or at least 1 year postmenopausal.
- Malignant disease, unless cured. Current prostate carcinoma without current or planned cytostatic therapy is allowed.
- Uncontrolled Diabetes mellitus.
- Signs of active infection, requiring systemic treatment.
- Positive Quantiferon test.
- Subject with positive hepatitis panel (including hepatitis B surface antigen [HBsAg], and / or anti-hepatitis B core antibodies, and / or hepatitis C virus antibody [anti-HCV]).
- History of anaphylaxis or severe allergic responses, including to radio-contrast agents.
- Planned live-virus vaccinations.
- Planned surgical interventions or planned elective hospital admissions within 6 weeks after AVF surgery. Planned hemodialysis sessions do not count as an exclusion criterion.
- Abnormal hepatic function (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) or bilirubin > 2 x upper limit of normal) at the time of the screening visit.
- Clinically significant out-of-range values on hematology panel, at discretion of the Principal Investigator.
- Current substance abuse or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
About this study
This study will investigate if liposomal prednisolone is effective in promoting arteriovenous fistula (AVF) maturation when administered to human subjects after surgical creation of a radio-cephalic AVF.
Read the detailed description
AVFs are the preferred means of vascular access for maintenance hemodialysis. Nonmaturation occurs in 30-50% of cases, with highest rates in radio-cephalic fistulas. Inflammatory cytokines are involved in this process of nonmaturation. By suppressing inflammation, corticosteroids might promote maturation, but have significant systemic side effects. Liposomal prednisolone has a long circulation time and targets inflamed tissue with low systemic concentrations and limited side effects. In an animal study, it was demonstrated to promote AVF maturation. At present, no drug therapy aimed at improving shunt maturation is available. This study will investigate if liposomal prednisolone is effective in promoting AVF maturation when administered to human subjects after surgical creation of a radio-cephalic AVF.
- Conditions
- Renal Dialysis, Hemodynamics, Vascular Remodeling, Neointima
- Being tested
- PEG-liposomal prednisolone sodium phosphate, Placebo
- Keywords
- Vascular access, Hemodialysis, Arteriovenous shunt, Arteriovenous fistula, Maturation, Liposomal prednisolone, PEG-liposomal prednisolone sodium phosphate, Radio-cephalic, Shunt
- Medical subject headings
- Vascular Remodeling, Neointima, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-liposomal prednisolone sodium phosphateDrug
Also called Nanocort
Liposomal prednisolone
PlaceboDrug
0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| Liposomal prednisolone | Experimental | Treatment with polyethylene glycol (PEG)-liposomal prednisolone sodium phosphate 150mg in 500ml saline intravenously at 1 and 15 days post surgery. Receives: Drug: PEG-liposomal prednisolone sodium phosphate |
| Placebo | Placebo comparator | Treatment with 500ml normal 0.9% saline intravenously at 1 and 15 days post surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cephalic vein diameter
Echographic measurement of the diameter of the cephalic vein, six weeks after surgical creation of the radiocephalic shunt.
Measured: 6 weeks after surgical creation of the radiocephalic shunt.
Secondary outcomes (5)
Cephalic vein diameter
Echographic measurement of the diameter of the cephalic vein, three months after surgical creation of the radiocephalic shunt.
Measured: 3 months after surgical creation of the radiocephalic shunt.
Radial artery diameter
Echographic measurement of the diameter of the radial artery, six weeks after surgical creation of the radiocephalic shunt.
Measured: 6 weeks after surgical creation of the radiocephalic shunt.
Radial artery diameter
Echographic measurement of the diameter of the radial artery, three months after surgical creation of the radiocephalic shunt.
Measured: 3 months after surgical creation of the radiocephalic shunt.
Radial artery flow.
Echographic measurement of the flow of the radial artery, six weeks after surgical creation of the radiocephalic shunt.
Measured: 6 weeks after surgical creation of the radiocephalic shunt.
Radial artery flow.
Echographic measurement of the flow of the radial artery, three months after surgical creation of the radiocephalic shunt.
Measured: 3 months after surgical creation of the radiocephalic shunt.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startNov 2015
- Primary completion30 May 2018
- Study completion30 May 2018
Why it stopped: Slow inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- 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
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- HagaZiekenhuis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), OLVG, Medical Center Haaglanden, Reinier de Graaf Groep, Spaarne Gasthuis, Alrijne Hospital, Tergooi Ziekenhuis
- Responsible party
- Principal investigator, JorisRotmans, Leiden University Medical Center
- Investigators
- Joris I Rotmans, MD PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495662
- Sponsor's protocol ID
- LIPMAT
- Acronym
- LIPMAT
- Status last verified
- May 2018
- First submitted
- 2 Jul 2015
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation
- ClinicalTrials.gov ID
- NCT02495662
- Acronym / sponsor ID
- LIPMAT / LIPMAT
- Conditions
- Renal Dialysis, Hemodynamics, Vascular Remodeling, Neointima
- Keywords
- Vascular access, Hemodialysis, Arteriovenous shunt, Arteriovenous fistula, Maturation, Liposomal prednisolone, PEG-liposomal prednisolone sodium phosphate, Radio-cephalic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow inclusion
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- HagaZiekenhuis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), OLVG, Medical Center Haaglanden, Reinier de Graaf Groep, Spaarne Gasthuis, Alrijne Hospital, Tergooi Ziekenhuis
- Study start
- Nov 2015
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 13 Jul 2015 (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 investigate if liposomal prednisolone is effective in promoting arteriovenous fistula (AVF) maturation when administered to human subjects after surgical creation of a radio-cephalic AVF.
Detailed description
AVFs are the preferred means of vascular access for maintenance hemodialysis. Nonmaturation occurs in 30-50% of cases, with highest rates in radio-cephalic fistulas. Inflammatory cytokines are involved in this process of nonmaturation. By suppressing inflammation, corticosteroids might promote maturation, but have significant systemic side effects. Liposomal prednisolone has a long circulation time and targets inflamed tissue with low systemic concentrations and limited side effects. In an animal study, it was demonstrated to promote AVF maturation. At present, no drug therapy aimed at improving shunt maturation is available. This study will investigate if liposomal prednisolone is effective in promoting AVF maturation when administered to human subjects after surgical creation of a radio-cephalic AVF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal prednisolone | Experimental | Drug: PEG-liposomal prednisolone sodium phosphateTreatment with polyethylene glycol (PEG)-liposomal prednisolone sodium phosphate 150mg in 500ml saline intravenously at 1 and 15 days post surgery. |
| Placebo | Placebo comparator | Drug: PlaceboTreatment with 500ml normal 0.9% saline intravenously at 1 and 15 days post surgery. |
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 who are scheduled for creation of a radiocephalic AVF for maintenance hemodialysis.
- Male or female ≥ 18 years old.
- Patients are able and willing to give written informed consent.
Key exclusion criteria (22 listed)
- Any concurrent illness, disability or clinically significant abnormality that may, as judged by the investigator, affect the interpretation of clinical efficacy or safety data or prevent the subject from safely completing the assessments required by the protocol.
- Current participation in another interventional clinical trial or subjects who have received an investigational drug within 30 days prior to the baseline visit.
- History of psychosis.
- History of osteonecrosis
- Previous AVF in the ipsilateral arm.
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 |
|---|---|---|
| PEG-liposomal prednisolone sodium phosphateAlso: NanocortLiposomal prednisolone | Drug | Liposomal prednisolone |
| Placebo0.9% normal saline | Drug | Placebo |
Primary outcome
Cephalic vein diameter
Time frame: 6 weeks after surgical creation of the radiocephalic shunt.
Echographic measurement of the diameter of the cephalic vein, six weeks after surgical creation of the radiocephalic shunt.
5 secondary outcomes
Cephalic vein diameter
Time frame: 3 months after surgical creation of the radiocephalic shunt.
Radial artery diameter
Time frame: 6 weeks after surgical creation of the radiocephalic shunt.
Radial artery diameter
Time frame: 3 months after surgical creation of the radiocephalic shunt.
Radial artery flow.
Time frame: 6 weeks after surgical creation of the radiocephalic shunt.
Radial artery flow.
Time frame: 3 months after surgical creation of the radiocephalic shunt.
Results and safety
The study was stopped early (reason given: Slow inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Joris I Rotmans, MD PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEG-liposomal prednisolone sodium phosphate in people with Renal Dialysis and Hemodynamics, run by Leiden University Medical Center at 1 site in Netherlands.
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 22 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 18 Sep 2018. 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 Netherlands. 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: Slow inclusion). 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?
Cephalic vein diameter (time frame: 6 weeks after surgical creation of the radiocephalic shunt.). 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 Sep 2018.