Azilsartan in Patients With Diabetic Kidney Disease and Hypertension

NCT05753696 | Unknown

• 1 other identifier: 2022-106
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension is the most common complication in patients with diabetes nephropathy. Strengthening blood pressure and blood sugar control is the basic treatment for patients with diabetes nephropathy. Angiotensin receptor blocker (ARB) and angiotensin-converting enzyme inhibitor (ACEI) are the first line drugs recommended in domestic and international guidelines for diabetes patients to control hypertension. As a new ARB drug, azilsartan has been found to have better antihypertensive effect than other ARB drugs. However, due to the limited sample size and study time, azilsartan has no significant advantage over other ARB drugs in terms of renal protection effect, and has not been systematically studied in diabetes nephropathy population. This study is intended to evaluate the effect of azilsartan on proteinuria and blood pressure improvement in patients with diabetes nephropathy and hypertension through clinical randomized controlled study, so as to accumulate evidence-based evidence of azilsartan in the comprehensive management of heart and kidney protection in this group of people, and promote the development of comprehensive treatment for patients with metabolic disease and renal injury combined with hypertension. This study will compare the advantages and disadvantages of azilsartan and classical ARB drug losartan potassium in terms of proteinuria, blood pressure control and renal function protection in patients with diabetes nephropathy and hypertension; We propose that the main indicator is the change of urinary albumin/creatinine ratio relative to the baseline, and the secondary indicator is the change of 24-hour urinary protein relative to the baseline; Change of blood pressure relative to baseline; Renal function, electrolyte and blood glucose.

Conditions

Proteinuria; Kidney Dysfunction; Blood Pressure; Diabetic Kidney Disease

Keywords

diabetic kidney disease; hypertension

Outcome Measures

Primary Outcomes (1)

• proteinuria

  urinary protein

  up to 16 weeks

Secondary Outcomes (4)

• 24 hour urine protein

  up to 16 weeks

• blood pressure

  up to 16 weeks

• kidney function

  up to 16 weeks

• urinary albumin/ creatine

  up to 16 weeks

Study Arms (2)

azilsartan group

EXPERIMENTAL

the initial dose of azilsartan is 20mg/day, if not reached the goal of blood pressure, azilsartan was adjust to 40mg/day

Drug: Azilsartan

losartan group

ACTIVE COMPARATOR

the initial dose of losartan is 40mg/day, if not reached the goal of blood pressure, losartan was adjust to 80mg/day

Drug: Losartan

Interventions

Azilsartan DRUG

Azilsartan initial dose 20mg/d, if not reached the goal of hypertension; azilsartan dose 40mg/d

azilsartan group

Losartan DRUG

losartan initial dose 40mg/d, if not reached the goal of hypertension; losartan 100mg/d

losartan group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30 to 70;
• Type 2 diabetes diagnosed according to American Diabetes Association guidelines has stable blood sugar control, and glycosylated hemoglobin is less than 7.5%;
• The patient's blood pressure Systemic Blood Pressure (SBP) \>140 or Diastolic Blood Pressure (DBP) \>90 mmHg, has not taken antihypertensive drugs or is taking non-ARB/ACEI antihypertensive drugs;
• Urine albumin/creatinine ratio\>300mg/g.

You may not qualify if:

• Type 1 diabetes;
• The patient is considered as non-essential hypertension, such as hypertension caused by renal hypertension or endocrine disease;
• Contraindications of ARB drugs, such as pregnancy status, bilateral renal artery stenosis, allergy to ARB drugs and their excipients;
• It is expected that dialysis treatment will be carried out within 6 months;
• Patients with malignant tumors;
• Patients with mental illness;
• The researcher believes that others are not suitable for this study.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Afficiated Hospital, Zhejiang University, School of Medicine

Hanzhou, Zhejiang, China

RECRUITING

Related Publications (1)

• Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2.

  PMID: 38682786 DERIVED

MeSH Terms

Conditions

Proteinuria; Diabetic Nephropathies; Hypertension

Interventions

azilsartan; Losartan

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Zhida Chen

  The second afiliated hospital of zhejiang university, school of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhida chen, Dr

CONTACT

15168417788; 715264276@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: March 3, 2023
• Study Start: April 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 3, 2023

Record last verified: 2023-02

Locations

CN (1)