Back to resultsA Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy
Primary Purpose
Glomerulonephritis, IGA, Hypertension
Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
aliskiren
Sponsored by
About this trial
This is an interventional treatment trial for Glomerulonephritis, IGA focused on measuring Aliskiren, Albuminuria, Angiotensinogen, collagen type IV, Transforming Growth Factor beta, aldosterone, renin, prorenin receptor, des-angiotensin I renin substrate, oxidative stress, advanced glycosylation end-product receptor, N,N-dimethylarginine
Eligibility Criteria
Inclusion Criteria:
- IgA nephropathy confirmed by renal biopsy
- Hypertension (<= 125/75 mmHg)
Exclusion Criteria:
- Patients who have been treated with angiotensin type 1 receptor blocker or angiotensin-converting enzyme inhibitor within 4 weeks
- Severe hypertension (<= 180/110 mmHg) or secondary hypertension
- Patients with history of allergy or adverse effect for aliskiren
- Renal dysfunction (estimated Glomerular Filtration Rate < 60 mL/min/1.73m2)
- Pregnancy
- Patient treated with cyclosporine
- Hyperkalemia (serum potassium >= 5.6 mmol/L)
- Autoimmune disease including systemic lupus erythematosus
- Patients inadequate for the study
Sites / Locations
- Kurume University, School of MedicineRecruiting
- Department of Internal Medicine, Osaka City General HospitalRecruiting
- Ohno memorial Hospital
- Kinki University, Faculty of MedicineRecruiting
Outcomes
Primary Outcome Measures
Renal function (Creatinine clearance)
Urinary protein
Secondary Outcome Measures
Urinary angiotensinogen
Urinary type 4 collagen
Urinary Transforming growth factor-beta
High-sensitivity C-reactive protein
Plasma Rennin Activity
Aldosterone
Asymmetric dimethylarginine
Advanced glycation end product
(Pro)renin receptor
Oxidative stress
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01184599
Brief Title
A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Kagawa University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin inhibitor, on renal function and progress of renal disease in hypertensive patients with IgA nephropathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, IGA, Hypertension
Keywords
Aliskiren, Albuminuria, Angiotensinogen, collagen type IV, Transforming Growth Factor beta, aldosterone, renin, prorenin receptor, des-angiotensin I renin substrate, oxidative stress, advanced glycosylation end-product receptor, N,N-dimethylarginine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
aliskiren
Intervention Description
150 mg/day p.o.
Primary Outcome Measure Information:
Title
Renal function (Creatinine clearance)
Time Frame
One year (every 6 months)
Title
Urinary protein
Time Frame
One year (every 6 months)
Secondary Outcome Measure Information:
Title
Urinary angiotensinogen
Time Frame
One year (every 6 months)
Title
Urinary type 4 collagen
Time Frame
One year (every 6 months)
Title
Urinary Transforming growth factor-beta
Time Frame
One year (every 6 months)
Title
High-sensitivity C-reactive protein
Time Frame
One year (every 6 months)
Title
Plasma Rennin Activity
Time Frame
One year (every 12 months)
Title
Aldosterone
Time Frame
One year (every 12 months)
Title
Asymmetric dimethylarginine
Time Frame
One year (every 12 months)
Title
Advanced glycation end product
Time Frame
One year (every 12 months)
Title
(Pro)renin receptor
Time Frame
One year (every 12 months)
Title
Oxidative stress
Time Frame
One year (every 12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IgA nephropathy confirmed by renal biopsy
Hypertension (<= 125/75 mmHg)
Exclusion Criteria:
Patients who have been treated with angiotensin type 1 receptor blocker or angiotensin-converting enzyme inhibitor within 4 weeks
Severe hypertension (<= 180/110 mmHg) or secondary hypertension
Patients with history of allergy or adverse effect for aliskiren
Renal dysfunction (estimated Glomerular Filtration Rate < 60 mL/min/1.73m2)
Pregnancy
Patient treated with cyclosporine
Hyperkalemia (serum potassium >= 5.6 mmol/L)
Autoimmune disease including systemic lupus erythematosus
Patients inadequate for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Masahito Imanishi
Phone
+81-6-6929-1221
Email
masachan@msic.med.osaka-cu.ac.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Hirofumi Hitomi
Phone
+81-87-891-2125
Email
hitomi@kms.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masahito Imanishi
Organizational Affiliation
Osaka City General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kurume University, School of Medicine
City
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Department of Internal Medicine, Osaka City General Hospital
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masahito Imanishi
Phone
+81-6-6929-1221
Email
masachan@msic.med.osaka-cu.ac.jp
First Name & Middle Initial & Last Name & Degree
Masahito Imanishi
Facility Name
Ohno memorial Hospital
City
Osaka
ZIP/Postal Code
550-0015
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Kinki University, Faculty of Medicine
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy
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