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IRCT20090701002113N4 IRCT 2025-12-19 Shiraz University of Medical Sciences PEG-G-CSF in Non-responder Hemodialysis Patients HBs-Vaccination Effects of Pegylated Filgrastim (PEG-G-CSF) Adjuvant on Improving Response to Hepatitis B Vaccine and HBs-Ab Serum Levels in Non-responder Chronic Hemodialysis Patients- A Randomized Double-Blind Clinical Trial 2025-12-31 anticipated 80 Recruiting https://irct.ir/trial/88032 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be performed by an independent statistician using a computerized random number generator via the SAS 9.3 software block randomization method (SAS Institute, Cary, NC, USA). Eligible participants will be randomly assigned 1:1 to a control group or a treatment group. All individuals who meet the inclusion/exclusion criteria at the first visit will be assigned to a group using the blocked randomization method, based on the allocation codes. Each patient will be assigned a unique study number. An independent data administrator who is not involved in clinical practice or patient recruitment will generate the randomization sequence, Blinding description: In this study, a double-blind design will be implemented. Participants, researchers, outcome assessors, and statisticians will remain unaware of the treatment allocation to prevent any bias resulting from expectations or preconceived notions. To ensure this, randomization lists will be generated by an independent data manager who is not involved in the study, using a computerized system. After generation, these lists will remain concealed from the researchers and other study team members and will be kept strictly confidential. Treatment allocation to participants will be done automatically by the software in a centralized manner, without human intervention. As a result, none of the researchers or outcome assessors will have knowledge of the treatment assigned to the participants throughout the study, and this process will remain confidential until the final analysis and result reporting. 2 End-stage Kidney disease. Intervention 1: Intervention group: will receive a dose of 6 mg/0.6 mL subcutaneous PEG-G-CSF 24 hours before the first booster dose of HBV vaccine IM, and receive the other two booster doses in the 2nd and 6th months. Intervention 2: Control group: will receive three booster dose of HBV vaccine IM (0, 2nd, 6th months). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals. When: Access period starts 6 months after results are published. To whom: Only for researchers working in academic and scientific institutions. Conditions: Reporting data based on our analyses in the form of books, reviews, and meta-analyses. Where to obtain: Contact us with the following email: masjedi_f@sums.ac.ir How to obtain: Maximum two weeks after email sending and sufficient explanation of how the data will be used. Comments:
public Fatemeh Masjedi
6th floor, Nephro-Urology Research Center, Research Tower, Khalili Street
Shiraz Iran (Islamic Republic of) 7193635899 +98 71 3628 1528 roozbehj@hotmail.com Shiraz University of Medical Sciences scientific Fatemeh Masjedi
6th floor, Nephro-Urology Research Center, Research Tower, Khalili Street
Shiraz Iran (Islamic Republic of) 7193635899 +98 71 3628 1528 masjedi_f@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age range between 18 and 70 years Patients with dialysis adequacy 3 times a week Patients with negative serology for HBsAg, total anti-HBC, anti HCV, HIV 1 and 2 Receiving 3 IM doses of HBV vaccination and HBS-Ab titer <10 IU/L (non-responder patients) Patients of chronic renal failure with serum creatinine >2.0 mg/dL, Glomerular filtration rate (GFR) <60 mL/min on hemodialysis (HD) 18 years 70 years Both Patients with positive serology for HBsAg, total anti-HBC, anti HCV, HIV 1 and 2 Prior use of any immunomodulatory agents like steroids/vaccine adjuvants in last 6 months Receiving blood transfusion in previous 6 months Scheduled to have kidney transplantation within 3 months History of active cancer or active infection under treatment Pregnancy, childbearing potential during the study period, or breastfeeding N18.6 End stage renal disease Treatment - Drugs Treatment - Drugs Intervention group: will receive a dose of 6 mg/0.6 mL subcutaneous PEG-G-CSF 24 hours before the first booster dose of HBV vaccine IM, and receive the other two booster doses in the 2nd and 6th months. Control group: will receive three booster dose of HBV vaccine IM (0, 2nd, 6th months) HBs-Ab serum levels. Timepoint: Before first vaccin booster and one month after the last two vaccine boosters (3rd, 7th months). Method of measurement: HBs-Ab serum levels will be measured by ELISA methods. 5 ml of blood will be collected in K2-EDTA tubes and HBs-Ab will be measured before PEG-G-CSF and the first vaccine booster injection, and 1 month after the last two boosters. Response rate to hepatitis B vaccine. Timepoint: One month after the third booster dose (month 7 of the study period). Method of measurement: Calculating the percentage change from baseline antibody levels. Total leukocyte count. Timepoint: One month after the third booster dose (month 7 of the study period). Method of measurement: Performing CBC Diff test for patients. Neutrophil count. Timepoint: One month after the third booster dose (month 7 of the study period). Method of measurement: Performing CBC Diff test for patients. CinnaGen Shiraz University of Medical Sciences CinnaGen Approved 2024-06-16 Research Ethics Committees of School of Medicine - Shiraz University of Medical Sciences 7th floor, University Central Building, Zand street Shiraz Fars Iran (Islamic Republic of)