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

NCT02646397 | Unknown Phase 4 DMC

• 1 other identifier: CZKI-CKD-001
• Study Type: interventional
• Target: 508
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

glomerular filtration rate; hypertension

Outcome Measures

Primary Outcomes (1)

• Changes in estimated glomerular filtration rate

  Changes in eGFR at month 6

Secondary Outcomes (7)

• Abnormal renal events

  From baseline to month 6

• Changes in 24 hour proteinuria

  From baseline to month 6

• Changes in mean SBP

  From baseline to month 6

• Abnornal cardiovascular events

  At month 6

• Adverse Events

  From baseline to month 6

Study Arms (2)

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.

Drug: Fosinopril; Drug: Benidipine

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.

Drug: Fosinopril; Drug: Hydrochlorothiazide

Interventions

Fosinopril DRUG

Fosinopril is an angiotensin-converting enzyme inhibitor.

Also known as: Fosinopril Sodium, Squibb Brand of Fosinopril Sodium, Fosinil

Fosinopril,benidipine combination; Fosinopril,hydrochlorothiazide combination

Benidipine DRUG

Benidipine is a dihydropyridine-derived calcium channel blocker.

Also known as: benidipine hydrochloride

Fosinopril,benidipine combination

Hydrochlorothiazide DRUG

Hydrochlorothiazide is a diuretic medication.

Also known as: HCTZ, Dichlothiazide, HydroDIURIL

Fosinopril,hydrochlorothiazide combination

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead
• First Affiliated Hospital of Zhejiang University: collaborator
• Zhongda Hospital: collaborator
• Ruijin Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Sichuan Provincial People's Hospital: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator

Study Sites (1)

Department of Nephrology, Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Related Publications (1)

• 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.

  PMID: 28237959 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Interventions

Fosinopril; benidipine; benidipine hydrochloride; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phosphinic Acids; Organophosphorus Compounds; Organic Chemicals; Proline; Imino Acids; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Changlin Mei

  Division of Nephrology, Shanghai ChangZheng Hospital

  STUDY CHAIR

Central Study Contacts

Changlin Mei, MD

CONTACT

0086 21 81885411; chlmei1954@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Division of Nephrology

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: January 5, 2016
• Study Start: February 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 5, 2016

Record last verified: 2015-12

Locations

CN (1)