Clinical Trial: The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation

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.

Detailed Summary: 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.
Sponsor: Leiden University Medical Center

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.


Original Secondary Outcome:

  • Cephalic vein diameter [ Time Frame: 4 weeks after surgical creation of the radiocephalic shunt. ]
    Echographic measurement of the diameter of the cephalic vein, four weeks after surgical creation of the radiocephalic shunt.
  • 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.
  • Radial artery diameter [ Time Frame: 4 weeks after surgical creation of the radiocephalic shunt. ]
    Echographic measurement of the diameter of the radial artery, four weeks after surgical creation of the radiocephalic shunt.
  • 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.
  • 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.
  • Radial artery flow. [ Time Frame: 4 weeks after surgical creation of the radiocephalic shunt. ]
    Echographic measurement of the flow of the radial artery, four weeks after surgical creation of the radiocephalic shunt.
  • 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.
  • 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.


Information By: Leiden University Medical Center

Dates:
Date Received: July 2, 2015
Date Started: November 2015
Date Completion:
Last Updated: March 6, 2017
Last Verified: June 2016