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The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation (LIPMAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02495662
Recruitment Status : Terminated (Slow inclusion)
First Posted : July 13, 2015
Last Update Posted : September 18, 2018
Sponsor:
Collaborators:
HagaZiekenhuis
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OLVG
Medical Center Haaglanden
Reinier de Graaf Groep
Spaarne Gasthuis
Alrijne Hospital
Tergooi Ziekenhuis
Information provided by (Responsible Party):
JorisRotmans, Leiden University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Renal Dialysis Hemodynamics Vascular Remodeling Neointima Drug: PEG-liposomal prednisolone sodium phosphate Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation
Study Start Date : November 2015
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018


Arm Intervention/treatment
Experimental: Liposomal prednisolone
Treatment with polyethylene glycol (PEG)-liposomal prednisolone sodium phosphate 150mg in 500ml saline intravenously at 1 and 15 days post surgery.
Drug: PEG-liposomal prednisolone sodium phosphate
Liposomal prednisolone
Other Name: Nanocort

Placebo Comparator: Placebo
Treatment with 500ml normal 0.9% saline intravenously at 1 and 15 days post surgery.
Drug: Placebo
0.9% normal saline




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cephalic vein diameter [ Time Frame: 3 months after surgical creation of the radiocephalic shunt. ]
    Echographic measurement of the diameter of the cephalic vein, three months after surgical creation of the radiocephalic shunt.

  2. Radial artery diameter [ Time Frame: 6 weeks after surgical creation of the radiocephalic shunt. ]
    Echographic measurement of the diameter of the radial artery, six weeks after surgical creation of the radiocephalic shunt.

  3. Radial artery diameter [ Time Frame: 3 months after surgical creation of the radiocephalic shunt. ]
    Echographic measurement of the diameter of the radial artery, three months after surgical creation of the radiocephalic shunt.

  4. Radial artery flow. [ Time Frame: 6 weeks after surgical creation of the radiocephalic shunt. ]
    Echographic measurement of the flow of the radial artery, six weeks after surgical creation of the radiocephalic shunt.

  5. Radial artery flow. [ Time Frame: 3 months after surgical creation of the radiocephalic shunt. ]
    Echographic measurement of the flow of the radial artery, three months after surgical creation of the radiocephalic shunt.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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 non-steroidal anti-inflammatory drugs (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 (Alanine aminotransferase (ALT)/ aspartate aminotransferase (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495662


Locations
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Netherlands
Leiden University Medical Center
Leiden, Zuid Holland, Netherlands, 2333 ZA
Sponsors and Collaborators
Leiden University Medical Center
HagaZiekenhuis
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OLVG
Medical Center Haaglanden
Reinier de Graaf Groep
Spaarne Gasthuis
Alrijne Hospital
Tergooi Ziekenhuis
Investigators
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Principal Investigator: Joris I Rotmans, MD PhD Leiden University Medical Center

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Responsible Party: JorisRotmans, J.I. Rotmans, MD, PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT02495662     History of Changes
Other Study ID Numbers: LIPMAT
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JorisRotmans, Leiden University Medical Center:
Vascular access
Hemodialysis
Arteriovenous shunt
Arteriovenous fistula
Maturation
Liposomal prednisolone
PEG-liposomal prednisolone sodium phosphate
Radio-cephalic
Shunt
Additional relevant MeSH terms:
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Prednisolone phosphate
Fistula
Vascular Remodeling
Neointima
Pathological Conditions, Anatomical
Pathologic Processes
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents