This is a prospective, multi-center, randomized, open-label, parallel-arm controlled study, for which a total of 216 patients with type 2 diabetic nephropathy (Stage II-IV) will be enrolled. The subjects will be randomized to three groups in 1:1:1 ratio. One group receive Alfacalcidol 0.25ug/day and Irbesartan 150mg/day for 16 consecutive weeks. The second group receive Alfacalcidol 0.25ug/day alone for 16 consecutive weeks. The third group receive Irbesartan 150mg/day alone for 16 consecutive weeks. All subjects will be followed up for 4 weeks after medication is over. A total of 4 visits have been scheduled for this study at week 0, week 8, week 16, week 20.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Chenzhou NO.1 People's Hospital
Chenzhou, Hunan, China
Hunan Yiyang Central Hospital
Yiyang, Hunan, China
Changes in 24h urinary albumin excretion rate (UAER) by comparing visits at week 20 with the baseline
Time frame: at Week 20
Changes in 24h urinary protein quantity by comparing visits at week 20 with the baseline
Time frame: at Week 20
Changes in estimated glomerular filtration rate (eGFR) by comparing visits at week 20 with the baseline
Time frame: at Week 20
Changes in the urine levels of IL-6, MCP-1, TGF-β1, MIP-1β, and PTPN2 by comparing visits at week 20 with the baseline.
Time frame: at Week 20
Changes in serum levels of IL-6, MCP-1, TGF-β1, MIP-1β, and PTPN2 by comparing visits at week 20 with the baseline.
Time frame: at Week 20
Changes in urinary albumin / creatinine (UACR) of morning urine by comparing visits at week 20 with the baseline
Time frame: at Week 20
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.