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

Phase 4

Completed

• Conditions: Type 2 Diabetic Nephropathy
• Interventions: Drug: Alfacalcidol; Drug: Irbesartan

• Registration Number: NCT03147677
• Lead Sponsor: The Third Xiangya Hospital of Central South University

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 g...

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2016-07-28
• Study First Submitted: 2017-04-06
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-07
• Study First Posted: 2017-05-10
• Primary Completion: 2018-07-30
• Study Completion: 2018-12-30
• Last Update Submitted: 2019-10-09
• Last Update Posted: 2019-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alfacalcidol and Irbesartan	Alfacalcidol	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.
Alfacalcidol and Irbesartan	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.
Alfacalcidol	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.
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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Hunan Chenzhou NO.1 People's Hospital; 🇨🇳 Chenzhou, Hunan, China

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Hunan Yiyang Central Hospital; 🇨🇳 Yiyang, Hunan, China