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CompletedNCT03147677Updated Oct 10, 2019

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

A Phase 4 interventional study of Alfacalcidol and Irbesartan in Type 2 Diabetic Nephropathy, sponsored by The Third Xiangya Hospital of Central South University. Completed at 3 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-10-10.

Sponsored by The Third Xiangya Hospital of Central South University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2016, registered Apr 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetic Nephropathy

Keywords

  • Type 2 diabetic nephropathy
  • Alfacalcidol
03

In context

Lead sponsor

The Third Xiangya Hospital of Central South University is the lead sponsor of 98 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Alfacalcidol and 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.

    Drug: Alfacalcidol · Drug: Irbesartan

  • Active comparator
    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.

    Drug: Irbesartan

  • Active comparator
    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.

    Drug: Alfacalcidol

Interventions

06

What researchers measure

Primary outcomes

  1. Changes in 24h urinary albumin excretion rate (UAER) by comparing visits at week 20 with the baseline

    Time frame: at Week 20

  2. Changes in 24h urinary protein quantity by comparing visits at week 20 with the baseline

    Time frame: at Week 20

Secondary outcomes

  1. Changes in estimated glomerular filtration rate (eGFR) by comparing visits at week 20 with the baseline

    Time frame: at Week 20

  2. 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.

    Time frame: at Week 20

  3. Changes in serum levels of IL-6, MCP-1, TGF-β1, MIP-1β, and PTPN2 by comparing visits at week 20 with the baseline.

    Time frame: at Week 20

  4. Changes in urinary albumin / creatinine (UACR) of morning urine by comparing visits at week 20 with the baseline

    Time frame: at Week 20

Other outcomes

  1. Incidence of all adverse events (AEs) and serious adverse events (SAEs)

    Time frame: during the whole study from week 0 to week 20

07

Study locations

3 sites
  • The Third Xiangya Hospital of Central South University
    Changsha, Hunan 410000, China
  • Hunan Chenzhou NO.1 People's Hospital
    Chenzhou, Hunan 423000, China
  • Hunan Yiyang Central Hospital
    Yiyang, Hunan 413000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03147677
Lead sponsor
The Third Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
May 10, 2017
Start date
Jul 28, 2016
Primary completion
Jul 30, 2018
Completion
Dec 30, 2018
Last update
Oct 10, 2019

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Alfacalcidol · Irbesartan

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The Third Xiangya Hospital of Central South University

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