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Completed

NCT Number: NCT03147677

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

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.

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Key information

Conditions

Type 2 Diabetic Nephropathy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alfacalcidol

Drug

Other names: Alfacalcidol Soft Capsules

Irbesartan

Drug

Other names: Irbesartan Pills

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

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 10, 2017
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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