NCT02495662: LIPMAT

The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation

Terminated Phase 2 Last updated 17 September 2018

What this trial tests

Phase 2 trial testing PEG-liposomal prednisolone sodium phosphate in Renal Dialysis in 30 participants. Terminated before completion.

Timeline

1 November 2015

Primary endpoint
30 May 2018

30 May 2018

Quick facts

Lead sponsor	Leiden University Medical Center
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	1 November 2015
Primary completion	30 May 2018
Estimated completion	30 May 2018
Sites	1 location across Netherlands

Drugs / interventions tested

• PEG-liposomal prednisolone sodium phosphate — full drug profile →
• Placebo

Conditions studied

• Renal Dialysis — all drugs for Renal Dialysis →
• Hemodynamics — all drugs for Hemodynamics →
• Vascular Remodeling — all drugs for Vascular Remodeling →
• Neointima — all drugs for Neointima →

Sponsor

Leiden University Medical Center

Who can join

18 and older, any sex, with Renal Dialysis or Hemodynamics. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanoparticles in the clinic: An update.
   Anselmo AC, Mitragotri S. · · 2019 · cited 976× · PMID 31572799 · DOI 10.1002/btm2.10143
2. Nanoparticles in the clinic.
   Anselmo AC, Mitragotri S. · · 2016 · cited 773× · PMID 29313004 · DOI 10.1002/btm2.10003
3. Nanoparticles in the clinic: An update post COVID-19 vaccines.
   Anselmo AC, Mitragotri S. · · 2021 · cited 211× · PMID 34514159 · DOI 10.1002/btm2.10246
4. Recent advances in nanoparticle-based drug delivery systems for rheumatoid arthritis treatment.
   Nasra S, Bhatia D, Kumar A. · · 2022 · cited 48× · PMID 36134349 · DOI 10.1039/d2na00229a
5. Arteriovenous conduits for hemodialysis: how to better modulate the pathophysiological vascular response to optimize vascular access durability.
   Shiu YT, Rotmans JI, Geelhoed WJ, Pike DB, et al · · 2019 · cited 47× · PMID 30785348 · DOI 10.1152/ajprenal.00440.2018
6. A Randomized Trial of Liposomal Prednisolone (LIPMAT) to Enhance Radiocephalic Fistula Maturation: A Pilot Study.
   Voorzaat BM, van der Bogt KEA, Bezhaeva T, van Schaik J, et al · · 2020 · cited 11× · PMID 32775836 · DOI 10.1016/j.ekir.2020.05.030
7. Liposome Formulation and In Vitro Testing in Non-Physiological Conditions Addressed to Ex Vivo Kidney Perfusion.
   Pisani S, Chiesa E, Genta I, Dorati R, et al · · 2022 · cited 10× · PMID 35887348 · DOI 10.3390/ijms23147999
8. Medical adjuvant treatment to increase patency of arteriovenous fistulae and grafts.
   Mohamed I, Kamarizan MFA, Da Silva A. · · 2021 · cited 6× · PMID 34298589 · DOI 10.1002/14651858.cd002786.pub4