Benazepril for Advanced Chronic Renal Insufficiency

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Primary Purpose

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Benazepril

About this trial

This is an interventional treatment trial for Chronic Kidney Failure focused on measuring Advanced Chronic Renal Insufficiency, Benazepril

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: serum creatinine concentration 1.5-5.0 mg/dL (133-442 µmol/L) creatinine clearance 20 to70 mL/min/1.73 m2, with variations of less than 30 percent in the three months before the screening evaluation non-diabetic renal disease persistent proteinuria (defined as urinary protein excretion greater than 0.3 g/day for three or more months without evidence of urinary-tract infection or overt heart failure [New York Heart Association class III-IV]). Exclusion Criteria: immediate need for dialysis; treatment with corticosteroids, non-steroidal anti-inflammatory drugs or immunosuppressive drugs; renovascular disease; myocardial infarction or cerebrovascular accident in the year preceding the trial; connective-tissue disease; obstructive uropathy.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00270426

First Posted

December 23, 2005

Last Updated

May 4, 2006

Sponsor

Southern Medical University, China

1. Study Identification

Unique Protocol Identification Number

NCT00270426

Brief Title

Benazepril for Advanced Chronic Renal Insufficiency

Study Type

Interventional

2. Study Status

Record Verification Date

March 1999

Overall Recruitment Status

Terminated

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Southern Medical University, China

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to further determine whether benazepril, could safely slow the progression of renal dysfunction in non-diabetic patients with advanced renal insufficiency.

6. Conditions and Keywords

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

Chronic Kidney Failure

Keywords

Advanced Chronic Renal Insufficiency, Benazepril

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Benazepril

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: serum creatinine concentration 1.5-5.0 mg/dL (133-442 µmol/L) creatinine clearance 20 to70 mL/min/1.73 m2, with variations of less than 30 percent in the three months before the screening evaluation non-diabetic renal disease persistent proteinuria (defined as urinary protein excretion greater than 0.3 g/day for three or more months without evidence of urinary-tract infection or overt heart failure [New York Heart Association class III-IV]). Exclusion Criteria: immediate need for dialysis; treatment with corticosteroids, non-steroidal anti-inflammatory drugs or immunosuppressive drugs; renovascular disease; myocardial infarction or cerebrovascular accident in the year preceding the trial; connective-tissue disease; obstructive uropathy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fan Fan Hou, M.D.,Ph.D.

Organizational Affiliation

Southern Medical University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

16407508

Citation

Hou FF, Zhang X, Zhang GH, Xie D, Chen PY, Zhang WR, Jiang JP, Liang M, Wang GB, Liu ZR, Geng RW. Efficacy and safety of benazepril for advanced chronic renal insufficiency. N Engl J Med. 2006 Jan 12;354(2):131-40. doi: 10.1056/NEJMoa053107.

Results Reference

result

Chronic Kidney Failure

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial