ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 300 for:    "Diabetic Nephropathies"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03147677
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : October 25, 2017
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 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
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan
U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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


Contacts
Contact: Hao Zhang, Doctor +86-13975806919 zhanghaoliaoqing@163.com

Locations
China, Hunan
The Third Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410000
Contact: Hao Zhang, Doctor    +86-13975806919    zhanghaoliaoqing@163.com   
Hunan Chenzhou NO.1 People's Hospital Recruiting
Chenzhou, Hunan, China, 423000
Contact: Xiangpin Liao, bachelor    +81-13507359887    13507359887@139.com   
Hunan Yiyang Central Hospital Recruiting
Yiyang, Hunan, China, 413000
Contact: Xiaohua Deng, bachelor    +81-13707370981    yoyotyz@126.com   
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

Responsible Party: The Third Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03147677     History of Changes
Other Study ID Numbers: 320.6750.16025
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: October 25, 2017
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:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Irbesartan
Alfacalcidol
Hydroxycholecalciferols
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
Growth Substances