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ARIA (Atacand Renoprotection In NephropAthy Pt.) (PCR)

Primary Purpose

Non-diabetic Nephropathy With Hypertension

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Candesartan Cilexetil
Candesartan Cilexetil
Candesartan Cilexetil 32mg
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-diabetic Nephropathy With Hypertension focused on measuring Candesartan Cilexetil, Non-diabetic Nephropathy, hypertension, urine protein creatinine ratio

Eligibility Criteria

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

Inclusion Criteria:

  • hypertension; a)135mmHg < Systolic Blood Pressure <180mmHg and/or 85 mmHg < Diastolic Blood Pressure <100 mmHg. or b) The subject has been treated with antihypertensive medication
  • proteinuria (urinary protein/creatinine ratio between 500 mg/g and 5000 mg/g)

Exclusion Criteria:

  • Current serum-creatinine > 265 mmol/L (>3 mg/dL).
  • Current serum-potassium > 5.5 mmol/L
  • Known hypersensitivity to angiotensin (AT)1-receptor blocker

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Candesartan Cilexetil

Candesartan Cilexetil

Candesartan Cilexetil

Outcomes

Primary Outcome Measures

The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks
Decrease of urinary protein/creatinine ratio means improvement of renal disease.

Secondary Outcome Measures

Change of Systolic and Diastolic Blood Pressure From Baseline
Inflammatory Marker (Hs-C-peptide Reactive Protein)
To evaluate how to reduce and relate with cardiovascular risk
Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation
GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units)
Treatment-emergent Adverse Events
Prevalence of adverse events after treatment regardless causality. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition from the signing of the informed consent, whether or not considered causally related to the product.

Full Information

First Posted
December 13, 2007
Last Updated
August 19, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00573430
Brief Title
ARIA (Atacand Renoprotection In NephropAthy Pt.)
Acronym
PCR
Official Title
A 28-week, Randomised, Open-label, Parallel-Group, Multi-Center Study To Find the Effective Dose of Candesartan Cilexetil (Atacand) for Renoprotection in Korean Hypertensive Patients With Non-diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine the effective dose of candesartan cilexetil for reduction of urinary protein excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in urinary protein/creatinine ratio from baseline to the end of 28-week treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-diabetic Nephropathy With Hypertension
Keywords
Candesartan Cilexetil, Non-diabetic Nephropathy, hypertension, urine protein creatinine ratio

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Candesartan Cilexetil
Arm Title
2
Arm Type
Experimental
Arm Description
Candesartan Cilexetil
Arm Title
3
Arm Type
Experimental
Arm Description
Candesartan Cilexetil
Intervention Type
Drug
Intervention Name(s)
Candesartan Cilexetil
Other Intervention Name(s)
Atacand
Intervention Description
8 mg oral once daily dose
Intervention Type
Drug
Intervention Name(s)
Candesartan Cilexetil
Other Intervention Name(s)
Atacand
Intervention Description
16 mg oral once daily dose
Intervention Type
Drug
Intervention Name(s)
Candesartan Cilexetil 32mg
Other Intervention Name(s)
Atacand
Intervention Description
32 mg oral once daily dose
Primary Outcome Measure Information:
Title
The Change in Urinary Protein/Creatinine Ratio From Baseline to 28 Weeks
Description
Decrease of urinary protein/creatinine ratio means improvement of renal disease.
Time Frame
baseline to 28 weeks
Secondary Outcome Measure Information:
Title
Change of Systolic and Diastolic Blood Pressure From Baseline
Time Frame
baseline to 28 weeks
Title
Inflammatory Marker (Hs-C-peptide Reactive Protein)
Description
To evaluate how to reduce and relate with cardiovascular risk
Time Frame
baseline to 28 weeks
Title
Estimated GFR Predicted From the Modification of Diet in Renal Disease (MDRD) Equation
Description
GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.210 if African-American) (conventional units)
Time Frame
28 weeks
Title
Treatment-emergent Adverse Events
Description
Prevalence of adverse events after treatment regardless causality. An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition from the signing of the informed consent, whether or not considered causally related to the product.
Time Frame
Baseline to 28 weeks

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: hypertension; a)135mmHg < Systolic Blood Pressure <180mmHg and/or 85 mmHg < Diastolic Blood Pressure <100 mmHg. or b) The subject has been treated with antihypertensive medication proteinuria (urinary protein/creatinine ratio between 500 mg/g and 5000 mg/g) Exclusion Criteria: Current serum-creatinine > 265 mmol/L (>3 mg/dL). Current serum-potassium > 5.5 mmol/L Known hypersensitivity to angiotensin (AT)1-receptor blocker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Da Suk Han
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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ARIA (Atacand Renoprotection In NephropAthy Pt.)

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