A Prospective, Multi-center, Randomized, Open-label, Parallel-arm Controlled Study of Treating Type 2 Diabetic Nephropathy (Stage II-IV) With Alfacalcidol and Irbesartan
Overview
- Phase
- Phase 4
- Intervention
- Alfacalcidol
- Conditions
- Type 2 Diabetic Nephropathy
- Sponsor
- The Third Xiangya Hospital of Central South University
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Changes in 24h urinary albumin excretion rate (UAER) by comparing visits at week 20 with the baseline
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
- •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;
Arms & Interventions
Alfacalcidol and Irbesartan
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.
Intervention: Alfacalcidol
Alfacalcidol and Irbesartan
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.
Intervention: Irbesartan
Irbesartan
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.
Intervention: Irbesartan
Alfacalcidol
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.
Intervention: Alfacalcidol
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Changes in estimated glomerular filtration rate (eGFR) 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)
- 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)