Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients With Hypertension

Chronic Kidney Disease Clinical Trial

— BEAHIT  

Official title:

Comparison of Efficacy and Safety Between Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients With Hypertension: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02646397
• Other study ID #: CZKI-CKD-001
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 29, 2015
• Last updated: December 31, 2015
• Start date: February 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2015
• Source: Shanghai Changzheng Hospital
• Contact: Changlin Mei, MD
• Phone: 0086 21 81885411
• Email: chlmei1954[@]126.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 508
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with non-dialysis CKD at the enrollment and randomization eGFR= 30 ml/min per 1.73 m2 at the enrollment and randomization SBP> 130 mmHg and/or DBP > 80 mmHg at the enrollment and randomization. Patients could not receive more than two antihypertensive medications prior to our enrollment, and should discontinue the prior antihypertensive medications after the enrollment according to the investigators' advice.

2. 24 h proteinuria < 1.5g at the enrollment

3. Patients who signed the informed consent form

4. Baseline serum Cr < 3 mg/dL at the enrollment and randomization

Exclusion Criteria:

1. Hypertensive crisis (SBP > 180 mmHg and/or DBP>110 mmHg)

2. Refractory hypertension (taking > 2 antihypertensive drugs more than a month, SBP still > 160mm Hg or DBP > 100mmHg)

3. Baseline serum Cr > 3 mg/dl, or kidney transplantation

4. Patients diagnosed as severe cardiac arrhythmia (severe extra beats, supraventricular tachycardias, ventricular arrhythmias, or bradyarrhythmias), heart failure, NYHA >?, angina, stroke, left ventricular hypertrophy or myocardial infarction within 12 months prior to first visit.

5. Patients diagnosed as cancer or severe sepsis

6. Hematological system disorders: myelodysplastic syndrome, granulocytopenia, hypereosinophilic syndrome, polycythemia, thrombocytopenia, and et al.

7. Restrictive pericarditis

8. Systemic Lupus Erythematous

9. Severe diabetes complications such as diabetic ketoacidosis, hyperosmolar coma, retinopathy, amputation, and et al.

10. Patients diagnosed as hyperkalemia(>5.5mmol/L) within 6 months or at the enrollment

11. Renal artery stenosis or vascular embolism disease

12. Patient is currently pregnant or lactational

13. AST/ALT > three times of the upper limit of standard value at the baseline

14. Any severe allergy of CCB, diuretic or ACE inhibitor

15. History of severe side effects of CCB, diuretic or ACE inhibitor; long-term use of non-steroidal anti-inflammatory drugs

16. Use of other investigational drugs within 30 days or 5 half-lives of last visit, whichever is longer.

17. Other unsuitable patients judged by the investigators

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Fosinopril
Fosinopril is an angiotensin-converting enzyme inhibitor.
• Benidipine
Benidipine is a dihydropyridine-derived calcium channel blocker.
• Hydrochlorothiazide
Hydrochlorothiazide is a diuretic medication.

Locations

Country	Name	City	State
China	Department of Nephrology, Shanghai Changzheng Hospital	Shanghai	Shanghai

Sponsors (8)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital	First Affiliated Hospital of Zhejiang University, Ruijin Hospital, Sichuan Provincial People's Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Zhengzhou University, The Second Affiliated Hospital of Dalian Medical University, Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in estimated glomerular filtration rate		Changes in eGFR at month 6	No
Secondary	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	Yes
Secondary	Changes in 24 hour proteinuria		From baseline to month 6	No
Secondary	Changes in mean SBP		From baseline to month 6	No
Secondary	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	Yes
Secondary	Adverse Events	Number of participants with abnormal laboratory values and/or adverse events that are related to Treatment	From baseline to month 6	Yes
Secondary	Changes in urinary albumin excretion		From baseline to month 6	No
Secondary	Changes in mean DBP		From baseline to month 6	No