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Trial registered on ANZCTR


Registration number
ACTRN12611000809932
Ethics application status
Approved
Date submitted
29/07/2011
Date registered
2/08/2011
Date last updated
2/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Analysis of hemodialysed patients immune response to anti - Hepatitis B vaccination performing dialysis with an high capacity adsorbent polymethylmethacrylate membrane
Scientific title
Analysis of the effectiveness in clinical practice of the use of polymethylmethacrylate membrane dialyzer as adjuvant in the treatment of dialysis patients in the course of Hepatitis B vaccination
Secondary ID [1] 262745 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease patients immune system response to Hepatitis B vaccination 270454 0
Condition category
Condition code
Inflammatory and Immune System 270606 270606 0 0
Other inflammatory or immune system disorders
Renal and Urogenital 270607 270607 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Analysis of the effectiveness in practice of the use of polymethylmethacrylate membrane dialyzers as adjuvant in the treatment of dialysis patients in the course of anti - Hepatitis B vaccination.

Arm1: patients on maintainance thrice-weekly dialysis resulting non responder to anti-Hepatitis B vaccination in accordance with Center for Desease Control (CDC) and prevention criteria and discontinuing their actual dialysis membrane switching to a polymethylmethacrylate membrane with high pore size and a enhanced absorptive capacity for at least four month, at the third month receiving a regular vaccine booster dose.

Arm2: patients on maintainance thrice-weekly dialysis resulting non responder to anti-Hepatitis B vaccine with CDC criteria not using any kind of polymetylmethacrilate membrane dialyzers, at the third month receiving a regular vaccine booster dose.

We intend to observe if there is any difference between the two groups in term of response to the vaccine booster dose.
Intervention code [1] 267090 0
Treatment: Devices
Comparator / control treatment
Standard dialysis treatment performed with non polymethylmethacrylate membrane dialyzer.
Control group
Active

Outcomes
Primary outcome [1] 269340 0
Efficacy of anti-Hepatitis B vaccination in patients treated with polymethylmethacrylates membrane dialyzers. We expect a difference in the two groups of more than 25% in the number of patients with positive antibody response (Ab HBs > 10%) after the last dose of vaccine (booster).
Timepoint [1] 269340 0
Four months after starting observation period
Secondary outcome [1] 279412 0
Polymethylmethacrylate dialyzers are able decrease pre-dialysis serum level of sCD40 (soluble form of CD40)
Timepoint [1] 279412 0
Three months after starting observation period

Eligibility
Key inclusion criteria
End Stage Renal desease patients on mainteinance thrice-weekly dialysis treatment who had been defined as non-responder to Hepatitis B vaccination according to CDC criteria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
End Stage Renal desease patients on mainteinance thrice-weekly dialysis treatment who had been defined as non responder to Hepatitis B vaccination according to CDC criteria already using any kind of polymethylmethacrylate membrane dialyzers at the initial time of observation

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
the steering cometee prepares 40 closed envelopes ( 20 for the study group + 20 for the control group) and mixing up them
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
opening closed envelops with group A (study group) and B (control group)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3759 0
Italy
State/province [1] 3759 0

Funding & Sponsors
Funding source category [1] 267559 0
Hospital
Name [1] 267559 0
USL 8 Arezzo P.O. Ospedale S. Donato di Arezzo
Country [1] 267559 0
Italy
Primary sponsor type
Hospital
Name
USL 8 Arezzo P.O. Ospedale S. Donato di Arezzo
Address
Ospedale San Donato, Via Pietro Nenni 20 - 52100 - Arezzo - Italy
Country
Italy
Secondary sponsor category [1] 266602 0
Commercial sector/Industry
Name [1] 266602 0
Estor Spa
Address [1] 266602 0
Via Newton 12 - 20016 - Pero (MI) - Italy
Country [1] 266602 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269523 0
Comitato Etico Locale (CEL), USL 8 Arezzo
Ethics committee address [1] 269523 0
Ethics committee country [1] 269523 0
Italy
Date submitted for ethics approval [1] 269523 0
Approval date [1] 269523 0
21/06/2010
Ethics approval number [1] 269523 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32955 0
Address 32955 0
Country 32955 0
Phone 32955 0
Fax 32955 0
Email 32955 0
Contact person for public queries
Name 16202 0
Patrizio Imperiali
Address 16202 0
Ospedale San Donato di Arezzo - Via Pietro Nenni 20 - 52100 - Arezzo - Italy
Country 16202 0
Italy
Phone 16202 0
+390575255439
Fax 16202 0
Email 16202 0
[email protected]
Contact person for scientific queries
Name 7130 0
Patrizio Imperiali
Address 7130 0
Ospedale San Donato di Arezzo - Via Pietro Nenni 20 - 52100 - Arezzo - Italy
Country 7130 0
Italy
Phone 7130 0
+390575255439
Fax 7130 0
Email 7130 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.