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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alfacalcidol and Irbesartan | Experimental | The subjects in this group orally take Alfacalcidol Soft Capsules at 0.25ug/day and Irbesartan Pills at 150mg/day 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. |
|
| Irbesartan | Active Comparator | The subjects in this group orally take Irbesartan Pills at 150mg/day 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. |
|
| Alfacalcidol | Active Comparator | The subjects in this group orally takeAlfacalcidol Soft Capsules at 0.25ug/day 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfacalcidol | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 24h urinary albumin excretion rate (UAER) by comparing visits at week 20 with the baseline | at Week 20 | |
| Changes in 24h urinary protein quantity by comparing visits at week 20 with the baseline | at Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in estimated glomerular filtration rate (eGFR) by comparing visits at week 20 with the baseline | 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. | at Week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all adverse events (AEs) and serious adverse events (SAEs) | during the whole study from week 0 to week 20 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hao Zhang, Doctor | The Third Xiangya Hospital of Central South University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410000 | China | ||
| Hunan Chenzhou NO.1 People's Hospital |
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| ID | Term |
|---|---|
| C008088 | alfacalcidol |
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Irbesartan |
| Drug |
|
|
| Changes in serum levels of IL-6, MCP-1, TGF-β1, MIP-1β, and PTPN2 by comparing visits at week 20 with the baseline. | at Week 20 |
| Changes in urinary albumin / creatinine (UACR) of morning urine by comparing visits at week 20 with the baseline | at Week 20 |
| Chenzhou |
| Hunan |
| 423000 |
| China |
| Hunan Yiyang Central Hospital | Yiyang | Hunan | 413000 | China |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |