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Comparison of the response to HBS Ag vaccine in chronic renal failure patients with different GFR levels

Protocol summary

Summary
The objective of this study was to investigate effects of vaccination against hepatits B virus in inducing seroconversion in patients with chronic renal failure and different levels of kidney function. 150 patients including 50 patients with GFR between 40 and 60, 50 patients with GFR 15 and 40, and 50 patients with GFR less than 15 and also 150 healthy controls were included in the study. Three doses of recombinant HBS vaccines were injected intramuscularly at month 0, 3, and 6 with doses of 40 micrograms in intervention and 20 micrograms in control group. HBS Ab titers were measured and incidence of seroconversion was compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138803121267N8
Registration date: 2009-08-30, 1388/06/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-08-30, 1388/06/08
Registrant information
Name
Mojgan Borgheie
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University of Mediacal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
research@unrc.ir
Recruitment status
Recruitment complete
Funding source
Urology and Nephrology Research Center
Expected recruitment start date
2007-08-23, 1386/06/01
Expected recruitment end date
2009-08-23, 1388/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the response to HBS Ag vaccine in chronic renal failure patients with different GFR levels
Public title
Comparison of the response to HBS Ag vaccine in chronic renal failure patients with different GFR levels
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Presence of Chronic Renal Failure, age between 18 and 85 yea, negative HBS Ab, Exclusion criteria: Receiving immunosuppressive drug, previous HBV vaccinations
Age
From 18 years old to 85 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R.
Street address
UNRC, No.101, 9th Boostan St., Pasdaran Ave., Tehran, I.R.Iran
City
Tehran
Postal code
1666677951
Approval date
empty
Ethics committee reference number
75

Health conditions studied

1

Description of health condition studied
Chronic renal failure
ICD-10 code
N18
ICD-10 code description
Chronic renal failure

Primary outcomes

1

Description
HBS Ab
Timepoint
4-8 weeks after the latest vaccine dose
Method of measurement
lab test

Secondary outcomes

empty

Intervention groups

1

Description
Vaccination with Engrix with dosage of 40 milligramgr, IM in months 0, 1, 6
Category
Prevention

2

Description
Vaccination with Engrix with dosage of 20 milligram, IM in months 0, 1, 6
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Labafi Nejad Hospital
Full name of responsible person
Street address
Labafi Nejad Hospital, 9th Boostan St., Pasdaran Ave., Tehran, I.R.Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R.
Full name of responsible person
Shabnam Golshan
Street address
UNRC, No.101, 9th Boostan St., Pasdaran Ave., Tehran, I.R.Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R.
Full name of responsible person
Dr Mitra Mahdavi Mazde
Position
Assistant professor
Other areas of specialty/work
Street address
UNRC, No.101, 9th Boostan St., Pasdaran Ave., Tehran, I.R.Iran
City
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Fax
+98 212277954
Email
Research@unrc.ir
Web page address
www.unrc.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R.
Full name of responsible person
Dr Mitra Mahdavi Mazdeh
Position
Assistant professor
Other areas of specialty/work
Street address
No.101, 9th Boostan St., Pasdaran Ave., Tehran, I.R.Iran
City
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Fax
+98 212277954
Email
Research@unrc.ir
Web page address
www.unrc.ir

Person responsible for updating data

Contact
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R.
Full name of responsible person
Dr Mozhgan Borgheie
Position
General physician
Other areas of specialty/work
Street address
NRC, No.101, 9th Boostan St., Pasdaran Ave., Tehran, I.R.Iran
City
Tehran
Postal code
1666677951
Phone
+98 21 2256 7222
Fax
+98 212277954
Email
borgheie@unrc.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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