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

Primary Purpose

Type 2 Diabetic Nephropathy

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Alfacalcidol

Irbesartan

About this trial

This is an interventional treatment trial for Type 2 Diabetic Nephropathy focused on measuring Type 2 diabetic nephropathy, Alfacalcidol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Third Xiangya Hospital of Central South University
Hunan Chenzhou NO.1 People's Hospital
Hunan Yiyang Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Alfacalcidol and Irbesartan

Irbesartan

Alfacalcidol

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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.

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

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

Full Information

NCT ID

NCT03147677

First Posted

April 6, 2017

Last Updated

October 9, 2019

Sponsor

The Third Xiangya Hospital of Central South University

1. Study Identification

Unique Protocol Identification Number

NCT03147677

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

July 28, 2016 (Actual)

Primary Completion Date

July 30, 2018 (Actual)

Study Completion Date

December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Third Xiangya Hospital of Central South University

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetic Nephropathy

Keywords

Type 2 diabetic nephropathy, Alfacalcidol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alfacalcidol and Irbesartan

Arm Type

Experimental

Arm Description

Arm Title

Irbesartan

Arm Type

Active Comparator

Arm Description

Arm Title

Alfacalcidol

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Alfacalcidol

Other Intervention Name(s)

Alfacalcidol Soft Capsules

Intervention Type

Drug

Intervention Name(s)

Irbesartan

Other Intervention Name(s)

Irbesartan Pills

Primary Outcome Measure Information:

Title

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

Time Frame

at Week 20

Title

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

Time Frame

at Week 20

Secondary Outcome Measure Information:

Title

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

Time Frame

at Week 20

Title

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

Title

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

Title

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

Time Frame

at Week 20

Other Pre-specified Outcome Measures:

Title

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

Time Frame

during the whole study from week 0 to week 20

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hao Zhang, Doctor

Organizational Affiliation

The Third Xiangya Hospital of Central South University

Official's Role

Study Chair

Facility Information:

Facility Name

The Third Xiangya Hospital of Central South University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410000

Country

China

Facility Name

Hunan Chenzhou NO.1 People's Hospital

City

Chenzhou

State/Province

Hunan

ZIP/Postal Code

423000

Country

China

Facility Name

Hunan Yiyang Central Hospital

City

Yiyang

State/Province

Hunan

ZIP/Postal Code

413000

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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