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

Primary Purpose

Chronic Kidney Disease

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Fosinopril

Benidipine

Hydrochlorothiazide

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring glomerular filtration rate, hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
24 h proteinuria < 1.5g at the enrollment
Patients who signed the informed consent form
Baseline serum Cr < 3 mg/dL at the enrollment and randomization

Exclusion Criteria:

Hypertensive crisis (SBP > 180 mmHg and/or DBP>110 mmHg)
Refractory hypertension (taking > 2 antihypertensive drugs more than a month, SBP still > 160mm Hg or DBP > 100mmHg)
Baseline serum Cr > 3 mg/dl, or kidney transplantation
Patients diagnosed as severe cardiac arrhythmia (severe extra beats, supraventricular tachycardias, ventricular arrhythmias, or bradyarrhythmias), heart failure, NYHA >Ⅲ, angina, stroke, left ventricular hypertrophy or myocardial infarction within 12 months prior to first visit.
Patients diagnosed as cancer or severe sepsis
Hematological system disorders: myelodysplastic syndrome, granulocytopenia, hypereosinophilic syndrome, polycythemia, thrombocytopenia, and et al.
Restrictive pericarditis
Systemic Lupus Erythematous
Severe diabetes complications such as diabetic ketoacidosis, hyperosmolar coma, retinopathy, amputation, and et al.
Patients diagnosed as hyperkalemia(>5.5mmol/L) within 6 months or at the enrollment
Renal artery stenosis or vascular embolism disease
Patient is currently pregnant or lactational
AST/ALT > three times of the upper limit of standard value at the baseline
Any severe allergy of CCB, diuretic or ACE inhibitor
History of severe side effects of CCB, diuretic or ACE inhibitor; long-term use of non-steroidal anti-inflammatory drugs
Use of other investigational drugs within 30 days or 5 half-lives of last visit, whichever is longer.
Other unsuitable patients judged by the investigators

Sites / Locations

Department of Nephrology, Shanghai Changzheng Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Fosinopril,benidipine combination

Fosinopril,hydrochlorothiazide combination

Arm Description

254 CKD patients with HTN will take oral tablets of fosinopril (20 mg) plus benidipine (4/8 mg）once daily for 6 months.

254 CKD patients with HTN will take oral tablets of fosinopril (20 mg) plus hydrochlorothiazide (12.5/25 mg）once daily for 6 months.

Outcomes

Primary Outcome Measures

Changes in estimated glomerular filtration rate

Secondary Outcome Measures

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.

Changes in 24 hour proteinuria

Changes in mean SBP

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).

Adverse Events

Number of participants with abnormal laboratory values and/or adverse events that are related to Treatment

Changes in urinary albumin excretion

Changes in mean DBP

Full Information

NCT ID

NCT02646397

First Posted

December 29, 2015

Last Updated

December 31, 2015

Sponsor

Shanghai Changzheng Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02646397

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

February 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Changzheng Hospital

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

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

Chronic Kidney Disease

Keywords

glomerular filtration rate, hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

508 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fosinopril,benidipine combination

Arm Type

Experimental

Arm Description

254 CKD patients with HTN will take oral tablets of fosinopril (20 mg) plus benidipine (4/8 mg）once daily for 6 months.

Arm Title

Fosinopril,hydrochlorothiazide combination

Arm Type

Experimental

Arm Description

254 CKD patients with HTN will take oral tablets of fosinopril (20 mg) plus hydrochlorothiazide (12.5/25 mg）once daily for 6 months.

Intervention Type

Drug

Intervention Name(s)

Fosinopril

Other Intervention Name(s)

Fosinopril Sodium, Squibb Brand of Fosinopril Sodium, Fosinil

Intervention Description

Fosinopril is an angiotensin-converting enzyme inhibitor.

Intervention Type

Drug

Intervention Name(s)

Benidipine

Other Intervention Name(s)

benidipine hydrochloride

Intervention Description

Benidipine is a dihydropyridine-derived calcium channel blocker.

Intervention Type

Drug

Intervention Name(s)

Hydrochlorothiazide

Other Intervention Name(s)

HCTZ, Dichlothiazide, HydroDIURIL

Intervention Description

Hydrochlorothiazide is a diuretic medication.

Primary Outcome Measure Information:

Title

Changes in estimated glomerular filtration rate

Time Frame

Changes in eGFR at month 6

Secondary Outcome Measure Information:

Title

Abnormal renal events

Description

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.

Time Frame

From baseline to month 6

Title

Changes in 24 hour proteinuria

Time Frame

From baseline to month 6

Title

Changes in mean SBP

Time Frame

From baseline to month 6

Title

Abnornal cardiovascular events

Description

Time Frame

At month 6

Title

Adverse Events

Description

Number of participants with abnormal laboratory values and/or adverse events that are related to Treatment

Time Frame

From baseline to month 6

Title

Changes in urinary albumin excretion

Time Frame

From baseline to month 6

Title

Changes in mean DBP

Time Frame

From baseline to month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 24 h proteinuria < 1.5g at the enrollment Patients who signed the informed consent form Baseline serum Cr < 3 mg/dL at the enrollment and randomization Exclusion Criteria: Hypertensive crisis (SBP > 180 mmHg and/or DBP>110 mmHg) Refractory hypertension (taking > 2 antihypertensive drugs more than a month, SBP still > 160mm Hg or DBP > 100mmHg) Baseline serum Cr > 3 mg/dl, or kidney transplantation Patients diagnosed as severe cardiac arrhythmia (severe extra beats, supraventricular tachycardias, ventricular arrhythmias, or bradyarrhythmias), heart failure, NYHA >Ⅲ, angina, stroke, left ventricular hypertrophy or myocardial infarction within 12 months prior to first visit. Patients diagnosed as cancer or severe sepsis Hematological system disorders: myelodysplastic syndrome, granulocytopenia, hypereosinophilic syndrome, polycythemia, thrombocytopenia, and et al. Restrictive pericarditis Systemic Lupus Erythematous Severe diabetes complications such as diabetic ketoacidosis, hyperosmolar coma, retinopathy, amputation, and et al. Patients diagnosed as hyperkalemia(>5.5mmol/L) within 6 months or at the enrollment Renal artery stenosis or vascular embolism disease Patient is currently pregnant or lactational AST/ALT > three times of the upper limit of standard value at the baseline Any severe allergy of CCB, diuretic or ACE inhibitor History of severe side effects of CCB, diuretic or ACE inhibitor; long-term use of non-steroidal anti-inflammatory drugs Use of other investigational drugs within 30 days or 5 half-lives of last visit, whichever is longer. Other unsuitable patients judged by the investigators

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Changlin Mei, MD

Phone

0086 21 81885411

chlmei1954@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Changlin Mei

Organizational Affiliation

Division of Nephrology, Shanghai ChangZheng Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Nephrology, Shanghai Changzheng Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200003

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28237959

Citation

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.

Results Reference

derived

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

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