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Zainidip in Renal Artery Stenosis

Primary Purpose

Hypertension

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
stent
Aspirine
Clopidogrel
Lercanidipine
Sponsored by
Lee's Pharmaceutical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 40 - 75
  • Diameter of stenosis of renal artery or main branch of renal artery ≥60％. If diameter of stenosis is 60% - 75%, pressure difference between proximal and distal end ≥20 mm Hg (1mmHg=0.133kPa) or Captopril renography positive;
  • Systolic blood pressure before taking antihypertensive ≥180mmHg and/or diastolic blood pressure ≥110 mmHg; taking three antihypertensive including one diuretics with systolic blood pressure ≥140mmHg and/or ≥90 mmHg;
  • length of ipsilateral kidney is greater than 7.0cm.

Exclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) <30 ml/ (min﹒1.73 m 2) [eGFR (mL/min/1.73 m2) = 186.3 * serum creatinine (mg/dl) -1.154 * Age-0.203 * 0.742 (female)[11];
  • unstable condition and unable to tolerate interventional therapy;
  • anatomy of renal artery pathology not suitable for interventional therapy;
  • allergic to dihydropyridines;
  • III degree atrioventricular block
  • contrast allergy ;
  • any known malignant tumor;
  • non-compliant, history of alcoholism or drug abuse.

Sites / Locations

  • Fuwai Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis

Outcomes

Primary Outcome Measures

Glomerular filtration rate
Blood pressure

Secondary Outcome Measures

Full Information

First Posted
October 29, 2015
Last Updated
October 30, 2015
Sponsor
Lee's Pharmaceutical Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02594410
Brief Title
Zainidip in Renal Artery Stenosis
Official Title
The Efficacy of Renal Artery Stent Combined With Standardized Medical Therapy in Patients With Atherosclerotic Renal Artery Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lee's Pharmaceutical Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy of renal artery stent combined with standardized medical therapy as treatment for renal artery stenosis.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis
Intervention Type
Device
Intervention Name(s)
stent
Intervention Description
patients receiving renal artery stenting for renal artery atherosclerosis
Intervention Type
Drug
Intervention Name(s)
Aspirine
Intervention Description
100mg Qd
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
75mg Qd
Intervention Type
Drug
Intervention Name(s)
Lercanidipine
Intervention Description
10-20mg Qd
Primary Outcome Measure Information:
Title
Glomerular filtration rate
Time Frame
12 months
Title
Blood pressure
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 40 - 75 Diameter of stenosis of renal artery or main branch of renal artery ≥60％. If diameter of stenosis is 60% - 75%, pressure difference between proximal and distal end ≥20 mm Hg (1mmHg=0.133kPa) or Captopril renography positive; Systolic blood pressure before taking antihypertensive ≥180mmHg and/or diastolic blood pressure ≥110 mmHg; taking three antihypertensive including one diuretics with systolic blood pressure ≥140mmHg and/or ≥90 mmHg; length of ipsilateral kidney is greater than 7.0cm. Exclusion Criteria: Estimated glomerular filtration rate (eGFR) <30 ml/ (min﹒1.73 m 2) [eGFR (mL/min/1.73 m2) = 186.3 * serum creatinine (mg/dl) -1.154 * Age-0.203 * 0.742 (female)[11]; unstable condition and unable to tolerate interventional therapy; anatomy of renal artery pathology not suitable for interventional therapy; allergic to dihydropyridines; III degree atrioventricular block contrast allergy ; any known malignant tumor; non-compliant, history of alcoholism or drug abuse.
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

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Zainidip in Renal Artery Stenosis

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