IPMAT: liposomal prednisolone to improve the quality of a vascular access for hemodialysis

Phase 1

• Conditions: onmaturation of arteriovenous vascular accesses for hemodialysis.; MedDRA version: 19.0Level: LLTClassification code 10019480Term: HemodialysisSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-002488-40-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-01
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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 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.Diabetes mellitus, unless on a stable dose of antidiabetic medication or insulin for at least 4 weeks prior to inclusion.
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 (ALT/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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified