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

Sponsor
The Third Xiangya Hospital of Central South University (Other)
Overall Status
Completed
CT.gov ID
NCT03147677
Collaborator
(none)
60
Enrollment
3
Locations
3
Arms
29.1
Actual Duration (Months)
20
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 28, 2016
Actual Primary Completion Date :
Jul 30, 2018
Actual Study Completion Date :
Dec 30, 2018

Arms and Interventions

Arm Intervention/Treatment
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
Other Names:
  • Alfacalcidol Soft Capsules

    • Drug: Irbesartan
    Other Names:
  • Irbesartan Pills

    		•
    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
    Other Names:
  • Irbesartan Pills

    		•
    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
    Other Names:
  • Alfacalcidol Soft Capsules

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    Secondary Outcome Measures

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

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

    Other Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Third Xiangya Hospital of Central South University Changsha Hunan China 410000
    2 Hunan Chenzhou NO.1 People's Hospital Chenzhou Hunan China 423000
    3 Hunan Yiyang Central Hospital Yiyang Hunan China 413000

    Sponsors and Collaborators

    • The Third Xiangya Hospital of Central South University

    Investigators

    • Study Chair: Hao Zhang, Doctor, The Third Xiangya Hospital of Central South University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Third Xiangya Hospital of Central South University
    ClinicalTrials.gov Identifier:
    NCT03147677
    Other Study ID Numbers:
    • 320.6750.16025
    First Posted:
    May 10, 2017
    Last Update Posted:
    Oct 10, 2019
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by The Third Xiangya Hospital of Central South University
    Type 2 diabetic nephropathy
    Alfacalcidol
    Additional relevant MeSH terms:
    Kidney Diseases
    Diabetic Nephropathies
    Alfacalcidol
    Hydroxycholecalciferols
    Irbesartan

    Study Results

    No Results Posted as of Oct 10, 2019