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Clinical Trial Details

Trial ID: L1068
Source ID: NCT05423834
Associated Drug: Tenofovir Alafenamide
Title: Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Chronic Hepatitis B
Interventions: DRUG: Tenofovir alafenamide|DRUG: Entecavir
Outcome Measures: Primary: CKD at 12 months, To evaluate chronic kidney disease (CKD) progression at 12 months. The CKD progression is defined as an increase in CKD stage for at least 1 stage for at least 3 consecutive months during follow-up., 12 months | Secondary: Change in eGFR, calculated using the CKD Epidemiology Collaboration (CKD-EPI) equation expressed as a single equation: GFR (in mL/min/1.73 m2) = 141 × min (Scr /κ, 1)α × max(Scr /κ, 1)-1.209 × 0.993Age × 1.018 \[for the cases of females\] × 1.159 \[for the cases of ethnic Africans \]; where: Scr is the serum creatinine in mg/dL (equals to serum creatinine in micromole/L /88.4) , κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr /κ or 1, and max indicates the maximum of Scr /κ or 1.11 CKD stages 1, 2, 3A, 3B, 4 and 5 were defined based on eGFR, 12 months
Sponsor/Collaborators: Sponsor: Chinese University of Hong Kong
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 1800
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2022-09-01
Completion Date: 2026-12-31
Results First Posted:
Last Update Posted: 2023-02-08
Locations: Prince of Wales Hospital, Shatin, Hong Kong
URL: https://clinicaltrials.gov/show/NCT05423834