Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and Irbesartan

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multi-center, Randomized, Open-label, Parallel-arm Controlled Study of Treating Type 2 Diabetic Nephropathy (Stage II-IV) With Alfacalcidol and Irbesartan

Conditions
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Type 2 Diabetic Nephropathy

Intervention / Treatment
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* Drug: Alfacalcidol
* Drug: Irbesartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult Chinese subjects, at age 18-65, diagnosed with Type 2 diabetic nephropathy (Stage II-IV) who meet the WHO diagnostic standards of diabetes in 1999. The international Mogensen staging standard for diabetic nephropathy is used. Specifically, in Stage II (normal albuminuria stage), the UAER is normal (<20μg /min or<30mg/24h). In Stage III (early diabetic nephropathy stage), the UAER is 20-200μg /min or 30-300 mg/24h. In Stage IV (clinical or overt diabetic nephropathy stage), the UAER is >200μg/min or urine protein quantitation is >500mg /24h. Exclusion Criteria: Renal damage caused by other causes; Uncontrolled hypertension (blood pressure constantly greater than 140/ 90mmHg); Type 1 Diabetes Any acute and chronic infections; Glycosylated hemoglobin (HbA1c)>7.5%; 24h urinary protein quantity>3g, serum albumin<25g /L and estimated glomerular filtration rate (eGFR)<60 ml/min; Patients who suffered from malignant tumors or any illness that endanger life, such as liver, kidney, heart and lung function insufficiency over the past 5 years; People who have received the gastrointestinal operation, which may affect absorption of Vitamin D; People who have taken such drugs as angiotensin receptor blocker, calcium, and angiotensin converting enzyme inhibitor that affect excretion of urine protein, and who have been allergic to Vitamin D; Pregnant or lactating women; Other candidates that are deemed not suitable by investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alfacalcidol and Irbesartan<br>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. | Drug: Alfacalcidol<br> <br> * Other names: Alfacalcidol Soft Capsules;Drug: Irbesartan<br> <br> * Other names: Irbesartan Pills;|
| Active Comparator: Irbesartan<br>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. | Drug: Irbesartan<br> <br> * Other names: Irbesartan Pills;|
| Active Comparator: Alfacalcidol<br>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. | Drug: Alfacalcidol<br> <br> * Other names: Alfacalcidol Soft Capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetic nephropathy, Alfacalcidol