To demonstrate whether liposomal prednisolone is effective in promoting AVF maturation after surgical creation of a radiocephalic AVF.
ID
Source
Brief title
Condition
- Other condition
- Renal disorders (excl nephropathies)
- Vascular disorders NEC
Synonym
Health condition
vaattoegang bij hemodialyse
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The cephalic vein diameter at six weeks after surgery is the main study
endpoint.
Secondary outcome
Duplex ultrasound measurements at 6 weeks and 3 months after surgery :
- Cephalic vein diameter (6 wk is primary endpoint)
- Per-patient change of cephalic vein diameter
- Radial artery diameter
- Radial artery flow
Background summary
AVFs are the preferred means of vascular access for maintenance hemodialysis.
Nonmaturation occurs in 30-50% of cases, with highest rates in radiocephalic
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 radiocephalic AVF.
Study objective
To demonstrate whether liposomal prednisolone is effective in promoting AVF
maturation after surgical creation of a radiocephalic AVF.
Study design
Multi-centre, dual-blinded, randomized controlled trial with 1:1 randomization.
Intervention
The subjects will be randomised 1:1 into two groups. One group will receive 2
doses of 150 mg liposomal prednisolone at 1 day and 15 days after surgery. The
other group will receive a matching placebo at the same intervals (500 ml
normal saline).
Study burden and risks
The participants in the study will be burdened with two intravenous drug
administrations, one ultrasound examination in addition to standard care and
venipunctures during four visits. Additionally, at the screening visit, a
physical examination is performed. Risks associated with the study are the
chance of adverse effects of the study drug. Benefit and group relatedness: if
liposomal prednisolone promotes AVF maturation, patients receiving the drug
might be at a lower risk of needing additional surgical procedures to promote
AVF maturation or replace a failed AVF. Additionally, they will have more
options for new AVFs in the future.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
1. Patients who are scheduled for creation of a radiocephalic AVF for maintenance hemodialysis.
2. Male or female >= 18 years old.
3. Patients are able and willing to give written informed consent.
Exclusion criteria
1. 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.
2. Current participation in another interventional clinical trial or subjects who have received an investigational drug within 30 days prior to the baseline visit.
3. History of psychosis.
4. History of osteonecrosis
5. Previous AVF in the ipsilateral arm.
6. Current central venous catheter at the ipsilateral side with central venous obstruction.
7. 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.
8. Treatment with immunosuppressant drugs. Treatment with NSAIDs.
9. 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).
10. Women who are lactating, pregnant (positive pregnancy test at baseline) or planning to become pregnant during the course of the study.
11. 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.
12. Malignant disease, unless cured. Current prostate carcinoma without current or planned cytostatic therapy is allowed.
13. Uncontrolled Diabetes mellitus.
14. Signs of active infection, requiring systemic treatment.
15. Positive Quantiferon test.
16. 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]).
17. History of anaphylaxis or severe allergic responses, including to radio-contrast agents.
18. Planned live-virus vaccinations.
19. Planned surgical interventions or planned elective hospital admissions within 6 weeks after AVF surgery. Planned hemodialysis sessions do not count as an exclusion criterion.
20. Abnormal hepatic function (ALT/AST or bilirubin > 2 x upper limit of normal) at the time of the screening visit.
21. Clinically significant out-of-range values on hematology panel, at discretion of the Principal Investigator.
22. Current substance abuse or alcohol abuse.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2015-002488-40-NL |
ClinicalTrials.gov | NCT02495662 |
CCMO | NL53850.058.15 |