Clinical trial NCT03147677: Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and Irbesartan
Official title: A Prospective, Multi-center, Randomized, Open-label, Parallel-arm Controlled Study of Treating Type 2 Diabetic Nephropathy (Stage II-IV) With Alfacalcidol and Irbesartan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetic Nephropathy
Keywords: Type 2 diabetic nephropathy
Alfacalcidol
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: Changes in 24h urinary albumin excretion rate (UAER) by comparing visits at week 20 with the baseline
timeFrame: at Week 20
measure: Changes in 24h urinary protein quantity by comparing visits at week 20 with the baseline
timeFrame: at Week 20
Secondary outcomes:
measure: Changes in estimated glomerular filtration rate (eGFR) by comparing visits at week 20 with the baseline
timeFrame: at Week 20
measure: 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.
timeFrame: at Week 20
measure: Changes in serum levels of IL-6, MCP-1, TGF-β1, MIP-1β, and PTPN2 by comparing visits at week 20 with the baseline.
timeFrame: at Week 20
measure: Changes in urinary albumin / creatinine (UACR) of morning urine by comparing visits at week 20 with the baseline
timeFrame: at Week 20
Other outcomes:
measure: Incidence of all adverse events (AEs) and serious adverse events (SAEs)
timeFrame: during the whole study from week 0 to week 20
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Chenzhou
country: China
facility: Hunan Chenzhou NO.1 People's Hospital
state: Hunan
city: Yiyang
country: China
facility: Hunan Yiyang Central Hospital
state: Hunan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: Hao Zhang, Doctor
role: STUDY_CHAIR
References: