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

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Changzheng Hospital
• Collaborators: 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
• Treatments: Benidipine; Fosinopril; Hydrochlorothiazide

Criteria

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 >Ⅲ, 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