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

Primary Purpose

Renal Dialysis, Hemodynamics, Vascular Remodeling

Status
Terminated
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
PEG-liposomal prednisolone sodium phosphate
Placebo
Sponsored by
Leiden University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Dialysis focused on measuring Vascular access, Hemodialysis, Arteriovenous shunt, Arteriovenous fistula, Maturation, Liposomal prednisolone, PEG-liposomal prednisolone sodium phosphate, Radio-cephalic, Shunt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Leiden University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Liposomal prednisolone

Placebo

Arm Description

Treatment with polyethylene glycol (PEG)-liposomal prednisolone sodium phosphate 150mg in 500ml saline intravenously at 1 and 15 days post surgery.

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

Outcomes

Primary Outcome Measures

Cephalic vein diameter
Echographic measurement of the diameter of the cephalic vein, six weeks after surgical creation of the radiocephalic shunt.

Secondary Outcome Measures

Cephalic vein diameter
Echographic measurement of the diameter of the cephalic vein, three 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.
Radial artery diameter
Echographic measurement of the diameter of the radial artery, three 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.
Radial artery flow.
Echographic measurement of the flow of the radial artery, three months after surgical creation of the radiocephalic shunt.

Full Information

First Posted
July 2, 2015
Last Updated
September 17, 2018
Sponsor
Leiden University Medical Center
Collaborators
HagaZiekenhuis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), OLVG, Medical Center Haaglanden, Reinier de Graaf Groep, Spaarne Gasthuis, Alrijne Hospital, Tergooi Ziekenhuis
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1. Study Identification

Unique Protocol Identification Number
NCT02495662
Brief Title
The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation
Acronym
LIPMAT
Official Title
The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow inclusion
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Leiden University Medical Center
Collaborators
HagaZiekenhuis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), OLVG, Medical Center Haaglanden, Reinier de Graaf Groep, Spaarne Gasthuis, Alrijne Hospital, Tergooi Ziekenhuis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Dialysis, Hemodynamics, Vascular Remodeling, Neointima
Keywords
Vascular access, Hemodialysis, Arteriovenous shunt, Arteriovenous fistula, Maturation, Liposomal prednisolone, PEG-liposomal prednisolone sodium phosphate, Radio-cephalic, Shunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liposomal prednisolone
Arm Type
Experimental
Arm Description
Treatment with polyethylene glycol (PEG)-liposomal prednisolone sodium phosphate 150mg in 500ml saline intravenously at 1 and 15 days post surgery.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with 500ml normal 0.9% saline intravenously at 1 and 15 days post surgery.
Intervention Type
Drug
Intervention Name(s)
PEG-liposomal prednisolone sodium phosphate
Other Intervention Name(s)
Nanocort
Intervention Description
Liposomal prednisolone
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0.9% normal saline
Primary Outcome Measure Information:
Title
Cephalic vein diameter
Description
Echographic measurement of the diameter of the cephalic vein, six weeks after surgical creation of the radiocephalic shunt.
Time Frame
6 weeks after surgical creation of the radiocephalic shunt.
Secondary Outcome Measure Information:
Title
Cephalic vein diameter
Description
Echographic measurement of the diameter of the cephalic vein, three months after surgical creation of the radiocephalic shunt.
Time Frame
3 months after surgical creation of the radiocephalic shunt.
Title
Radial artery diameter
Description
Echographic measurement of the diameter of the radial artery, six weeks after surgical creation of the radiocephalic shunt.
Time Frame
6 weeks after surgical creation of the radiocephalic shunt.
Title
Radial artery diameter
Description
Echographic measurement of the diameter of the radial artery, three months after surgical creation of the radiocephalic shunt.
Time Frame
3 months after surgical creation of the radiocephalic shunt.
Title
Radial artery flow.
Description
Echographic measurement of the flow of the radial artery, six weeks after surgical creation of the radiocephalic shunt.
Time Frame
6 weeks after surgical creation of the radiocephalic shunt.
Title
Radial artery flow.
Description
Echographic measurement of the flow of the radial artery, three months after surgical creation of the radiocephalic shunt.
Time Frame
3 months after surgical creation of the radiocephalic shunt.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joris I Rotmans, MD PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
State/Province
Zuid Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

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The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation

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