CTRI/2022/07/044007
Suspended
Phase 3
A double blind randomized controlled trial to compare the serological response to 1.0 ml versus 2.0 ml intramuscular four doses schedule of hepatitis B vaccine in pre-dialysis chronic kidney disease (CKD) patients with eGFR below 60 ml/min
Indian Council of Medical Research ICMR0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)Health Condition 2: N184- Chronic kidney disease, stage 4 (severe)
- Sponsor
- Indian Council of Medical Research ICMR
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(i) Adults of between 19\-45 years of age
- •(ii) Who are unlikely to need MHD in next one year
- •(iii) Not had ever received hepatitis B vaccination, as suggested by history
- •(iv) HBsAg negative
- •(v) Body mass index (BMI) between 18\.5\-25 Kg/m2
Exclusion Criteria
- •(i) Hepatitis C virus or HIV coinfection
- •(ii) Post\-renal or other organ transplant recipients
- •(iii) On immunosuppressive medication, regardless of indication
- •(iv) Any chronic immunodeficiency condition
- •(v) Presence of malignancy, regardless of its nature and stage of disease
- •(vi) Presence of autoimmune condition
- •(vii) active alcohol intake or current smoker
- •(viii) Smoking or alcohol intake till recent past ( \<6months)
- •(ix) Pregnant and lactating women
Outcomes
Primary Outcomes
Not specified
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