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

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

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

Study Design

• 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

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 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

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

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

More Information

• 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: 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:

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