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| Name | Class |
|---|---|
| First Affiliated Hospital of Zhejiang University | OTHER |
| Zhongda Hospital | OTHER |
| Ruijin Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University |
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The purpose of this study is to compare the effect of fosinopril plus benidipine vs. fosinopril plus hydrochlorothiazide on the renal function during the 6-month treatment in CKD patients with HTN.
Patients with chronic kidney dysfunction or injury which affected the health over three months were diagnosed with chronic kidney disease (CKD).China has a high prevalence of CKD.The prevalence, awareness, and treatment of hypertension (HTN) in non-dialysis CKD patients were 67.3%,85.8%, and 81.0%, respectively. The renin-angiotensin system inhibitors (RASI) including angiotensin-converting enzyme inhibitor (ACEI) and angiotensin II type 1 receptor blocker (ARB) have been deeply confirmed to have apparent reno-protective effect in patients with CKD.Co-administration of diuretics and calcium channel blockers (CCBs) with ACEIs or ARBs are the most common combinations. Hydrochlorothiazide plus RASIs are another widely used combination according to the synergetic function of antihypertensive action and offset mutual adverse effects. Until now, no large scale studies have compared the effect of initial treatment with two different combinations of antihypertensive drugs in CKD patients on the progression of kidney disease in China. Studies in the subsets of CKD (diabetes and non-diabetes, micro-albuminuria and macro-albuminuria) are urgently needed.We aimed to conduct a large scale study to compare L/T-type CCB and diuretic on the basis of ACEI in CKD with HTN on renal progression of CKD in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fosinopril,benidipine combination | Experimental | 254 CKD patients with HTN will take oral tablets of fosinopril (20 mg) plus benidipine (4/8 mg)once daily for 6 months. |
|
| Fosinopril,hydrochlorothiazide combination | Experimental | 254 CKD patients with HTN will take oral tablets of fosinopril (20 mg) plus hydrochlorothiazide (12.5/25 mg)once daily for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fosinopril | Drug | Fosinopril is an angiotensin-converting enzyme inhibitor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in estimated glomerular filtration rate | Changes in eGFR at month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal renal events | Number of participants with 30% reduction of eGFR, doubling of serum creatinine concentration,end-stage renal disease (eGFR< 15 mL/min/1.73m²) or chronic dialysis. | From baseline to month 6 |
| Changes in 24 hour proteinuria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changlin Mei, MD | Contact | 0086 21 81885411 | chlmei1954@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Changlin Mei | Division of Nephrology, Shanghai ChangZheng Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology, Shanghai Changzheng Hospital | Shanghai | Shanghai Municipality | 200003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28237959 | Derived | Xue C, Zhou C, Yang B, Lv J, Dai B, Yu S, Wang Y, Zhao G, Mei C. Comparison of efficacy and safety between benidipine and hydrochlorothiazide in fosinopril-treated hypertensive patients with chronic kidney disease: protocol for a randomised controlled trial. BMJ Open. 2017 Feb 24;7(2):e013672. doi: 10.1136/bmjopen-2016-013672. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D017328 | Fosinopril |
| C061004 | benidipine |
| C050883 | benidipine hydrochloride |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D010721 | Phosphinic Acids |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D011392 | Proline |
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| OTHER |
| Sichuan Provincial People's Hospital | OTHER |
| The Second Affiliated Hospital of Dalian Medical University | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
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|
| Benidipine | Drug | Benidipine is a dihydropyridine-derived calcium channel blocker. |
|
|
| Hydrochlorothiazide | Drug | Hydrochlorothiazide is a diuretic medication. |
|
|
| From baseline to month 6 |
| Changes in mean SBP | From baseline to month 6 |
| Abnornal cardiovascular events | Number of participants with cardiovascular morbidity (nonfatal stroke, non-fatal myocardial infarction, resuscitated sudden cardiac death, unstable angina; and coronary revascularization procedures) and cardiovascular mortality (death due to sudden cardiac death, fatal stroke, fatal myocardial infarction, congestive heart failure or other cardiovascular causes). | At month 6 |
| Adverse Events | Number of participants with abnormal laboratory values and/or adverse events that are related to Treatment | From baseline to month 6 |
| Changes in urinary albumin excretion | From baseline to month 6 |
| Changes in mean DBP | From baseline to month 6 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007098 |
| Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |