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

Type 2 Diabetic Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147677
• Other study ID #: 320.6750.16025
• Status: Completed
• Phase: Phase 4
• Start date: July 28, 2016
• Est. completion date: December 30, 2018

Study information

• Verified date: May 2017
• Source: The Third Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases
• Type 2 Diabetic Nephropathy

Intervention

Drug:
• Alfacalcidol

• Irbesartan

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of all adverse events (AEs) and serious adverse events (SAEs)		during the whole study from week 0 to week 20
Primary	Changes in 24h urinary albumin excretion rate (UAER) by comparing visits at week 20 with the baseline		at Week 20
Primary	Changes in 24h urinary protein quantity by comparing visits at week 20 with the baseline		at Week 20
Secondary	Changes in estimated glomerular filtration rate (eGFR) by comparing visits at week 20 with the baseline		at Week 20
Secondary	Changes in the urine levels of IL-6, MCP-1, TGF-ß1, MIP-1ß, and PTPN2 by comparing visits at week 20 with the baseline.		at Week 20
Secondary	Changes in serum levels of IL-6, MCP-1, TGF-ß1, MIP-1ß, and PTPN2 by comparing visits at week 20 with the baseline.		at Week 20
Secondary	Changes in urinary albumin / creatinine (UACR) of morning urine by comparing visits at week 20 with the baseline		at Week 20