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

NCT03147677 — Phase 4, Completed, 60 participants, The Third Xiangya Hospital of Central South University

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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

Registry	NCT03147677
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	60 (Actual)
Sponsor	The Third Xiangya Hospital of Central South University (Other)
Conditions	Type 2 Diabetic Nephropathy
Interventions	Alfacalcidol, Irbesartan (Drug)
Dates	start 2016-07-28, primary completion 2018-07-30, completion 2018-12-30, first posted 2017-05-10, last updated 2019-10-10
Locations	3 sites in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Alfacalcidol and Irbesartan	Experimental	Drug: Alfacalcidol; Drug: 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.
Irbesartan	Active comparator	Drug: 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.
Alfacalcidol	Active comparator	Drug: 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.

Alfacalcidol (Drug), also known as Alfacalcidol Soft Capsules
Irbesartan (Drug), also known as Irbesartan Pills

+Outcome measures

Primary outcomes

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 outcomes

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]

Other outcomes

Incidence of all adverse events (AEs) and serious adverse events (SAEs) [during the whole study from week 0 to week 20]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.

+Locations (3)

Facility	City	Country
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

+Investigators

Hao Zhang, Doctor, Study chair, The Third Xiangya Hospital of Central South University

My Notes

Public

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