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Clinical Trials/CTRI/2022/07/044007
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Indian Council of Medical Research ICMR

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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