- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01184599
A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy
June 23, 2011 updated by: Kagawa University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Masahito Imanishi
- Phone Number: +81-6-6929-1221
- Email: masachan@msic.med.osaka-cu.ac.jp
Study Contact Backup
- Name: Hirofumi Hitomi
- Phone Number: +81-87-891-2125
- Email: hitomi@kms.ac.jp
Study Locations
-
-
-
Fukuoka, Japan, 830-0011
- Recruiting
- Kurume University, School of Medicine
-
Osaka, Japan, 534-0021
- Recruiting
- Department of Internal Medicine, Osaka City General Hospital
-
Contact:
- Masahito Imanishi
- Phone Number: +81-6-6929-1221
- Email: masachan@msic.med.osaka-cu.ac.jp
-
Principal Investigator:
- Masahito Imanishi
-
Osaka, Japan, 550-0015
- Not yet recruiting
- Ohno Memorial Hospital
-
Osaka, Japan, 589-8511
- Recruiting
- Kinki University, Faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Renal function (Creatinine clearance)
Time Frame: One year (every 6 months)
|
One year (every 6 months)
|
Urinary protein
Time Frame: One year (every 6 months)
|
One year (every 6 months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urinary angiotensinogen
Time Frame: One year (every 6 months)
|
One year (every 6 months)
|
Urinary type 4 collagen
Time Frame: One year (every 6 months)
|
One year (every 6 months)
|
Urinary Transforming growth factor-beta
Time Frame: One year (every 6 months)
|
One year (every 6 months)
|
High-sensitivity C-reactive protein
Time Frame: One year (every 6 months)
|
One year (every 6 months)
|
Plasma Rennin Activity
Time Frame: One year (every 12 months)
|
One year (every 12 months)
|
Aldosterone
Time Frame: One year (every 12 months)
|
One year (every 12 months)
|
Asymmetric dimethylarginine
Time Frame: One year (every 12 months)
|
One year (every 12 months)
|
Advanced glycation end product
Time Frame: One year (every 12 months)
|
One year (every 12 months)
|
(Pro)renin receptor
Time Frame: One year (every 12 months)
|
One year (every 12 months)
|
Oxidative stress
Time Frame: One year (every 12 months)
|
One year (every 12 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Masahito Imanishi, Osaka City General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Anticipated)
March 1, 2013
Study Registration Dates
First Submitted
August 16, 2010
First Submitted That Met QC Criteria
August 18, 2010
First Posted (Estimate)
August 19, 2010
Study Record Updates
Last Update Posted (Estimate)
June 27, 2011
Last Update Submitted That Met QC Criteria
June 23, 2011
Last Verified
May 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCGH-746
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on aliskiren
-
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Novartis PharmaceuticalsCompletedHypertensionUnited States, Belgium, Hungary, Turkey, Guatemala, Slovakia, Germany, Puerto Rico, Poland
-
Novartis PharmaceuticalsCompleted
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NovartisCompleted
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NovartisCompletedHypertensionUnited States
-
NovartisCompleted
-
NovartisCompletedHypertensionUnited States, Germany
-
Taipei Veterans General Hospital, TaiwanNational Taiwan University HospitalUnknown