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

NCT03147677 | Completed Phase 4

• 1 other identifier: 320.6750.16025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Type 2 Diabetic Nephropathy

Keywords

Type 2 diabetic nephropathy; Alfacalcidol

Outcome Measures

Primary Outcomes (2)

• 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 (4)

• 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 (1)

• Incidence of all adverse events (AEs) and serious adverse events (SAEs)

  during the whole study from week 0 to week 20

Study Arms (3)

Alfacalcidol and Irbesartan

EXPERIMENTAL

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.

Drug: Alfacalcidol; Drug: Irbesartan

Irbesartan

ACTIVE COMPARATOR

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.

Drug: Irbesartan

Alfacalcidol

ACTIVE COMPARATOR

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.

Drug: Alfacalcidol

Interventions

Alfacalcidol DRUG

Also known as: Alfacalcidol Soft Capsules

Alfacalcidol; Alfacalcidol and Irbesartan

Irbesartan DRUG

Also known as: Irbesartan Pills

Alfacalcidol and Irbesartan; Irbesartan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%;
• h 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (3)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Hunan Chenzhou NO.1 People's Hospital

Chenzhou, Hunan, 423000, China

Location

Hunan Yiyang Central Hospital

Yiyang, Hunan, 413000, China

Location

MeSH Terms

Interventions

alfacalcidol; Irbesartan

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Hao Zhang, Doctor

  The Third Xiangya Hospital of Central South University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: May 10, 2017
• Study Start: July 28, 2016
• Primary Completion: July 30, 2018
• Study Completion: December 30, 2018
• Last Updated: October 10, 2019

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)