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

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ClinicalTrials.gov Identifier: NCT03147677
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
The Third Xiangya Hospital of Central South University

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
Type 2 Diabetic Nephropathy Drug: Alfacalcidol Drug: Irbesartan Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : July 28, 2016
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

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 Name: Alfacalcidol Soft Capsules

Drug: Irbesartan
Other Name: 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 Name: 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 Name: Alfacalcidol Soft Capsules




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147677


Locations
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China, Hunan
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Hunan Chenzhou NO.1 People's Hospital
Chenzhou, Hunan, China, 423000
Hunan Yiyang Central Hospital
Yiyang, Hunan, China, 413000
Sponsors and Collaborators
The Third Xiangya Hospital of Central South University
Investigators
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Study Chair: Hao Zhang, Doctor The Third Xiangya Hospital of Central South University

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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    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Alfacalcidol
Hydroxycholecalciferols
Irbesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances