The LIPMAT Study: Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation

NCT02495662 | Terminated Phase 2 DMC

• 1 other identifier: LIPMAT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Cephalic vein diameter

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

  6 weeks after surgical creation of the radiocephalic shunt.

Secondary Outcomes (5)

• Cephalic vein diameter

  3 months after surgical creation of the radiocephalic shunt.

• Radial artery diameter

  6 weeks after surgical creation of the radiocephalic shunt.

• Radial artery diameter

  3 months after surgical creation of the radiocephalic shunt.

• Radial artery flow.

  6 weeks after surgical creation of the radiocephalic shunt.

• Radial artery flow.

  3 months after surgical creation of the radiocephalic shunt.

Study Arms (2)

Liposomal prednisolone

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PEG-liposomal prednisolone sodium phosphate DRUG

Liposomal prednisolone

Also known as: Nanocort

Liposomal prednisolone

Placebo DRUG

0.9% normal saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leiden University Medical Center: lead
• HagaZiekenhuis: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• OLVG: collaborator
• Medical Center Haaglanden: collaborator
• Reinier de Graaf Groep: collaborator
• Spaarne Gasthuis: collaborator
• Alrijne Hospital: collaborator
• Tergooi Ziekenhuis: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

MeSH Terms

Conditions

Vascular Remodeling; Neointima; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula

Study Officials

• Joris I Rotmans, MD PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: J.I. Rotmans, MD, PhD

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 13, 2015
• Study Start: November 1, 2015
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)