Glomerulonephritis, IGAPhase 4NCT01184599
A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy
A Phase 4 study testing aliskiren in people with Glomerulonephritis, IGA and Hypertension, run by Kagawa University at 4 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Glomerulonephritis, IGA, Hypertension
- What is being tested?
- aliskiren
- How many people
- 30 participants
- Where
- 4 sitesJapan
- Study dates
- Jun 2010to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- IgA nephropathy confirmed by renal biopsy
- Hypertension (<= 125/75 mmHg)
Who cannot join
- 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
Show all 9Show fewer
- Hyperkalemia (serum potassium >= 5.6 mmol/L)
- Autoimmune disease including systemic lupus erythematosus
- Patients inadequate for the study
Trial locations and contacts
4 sites in 1 country.
Japan4 sites, 4 recruiting
- Recruiting
Kurume University, School of Medicine
Fukuoka, 830-0011
- Recruiting
Department of Internal Medicine, Osaka City General Hospital
Osaka, 534-0021
Masahito Imanishi, +81-6-6929-1221, masachan@msic.med.osaka-cu.ac.jp
Masahito Imanishi
- Not yet recruiting
Ohno memorial Hospital
Osaka, 550-0015
- Recruiting
Kinki University, Faculty of Medicine
Osaka, 589-8511
About this study
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.
- Conditions
- Glomerulonephritis, IGA, Hypertension
- Being tested
- aliskiren
- 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
- Medical subject headings
- Glomerulonephritis, IGA, Hypertension, Albuminuria, Camurati-Engelmann Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aliskirenDrug
150 mg/day p.o.
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function (Creatinine clearance)
Measured: One year (every 6 months)
Urinary protein
Measured: One year (every 6 months)
Secondary outcomes (10)
Urinary angiotensinogen
Measured: One year (every 6 months)
Urinary type 4 collagen
Measured: One year (every 6 months)
Urinary Transforming growth factor-beta
Measured: One year (every 6 months)
High-sensitivity C-reactive protein
Measured: One year (every 6 months)
Plasma Rennin Activity
Measured: One year (every 12 months)
Aldosterone
Measured: One year (every 12 months)
Asymmetric dimethylarginine
Measured: One year (every 12 months)
Advanced glycation end product
Measured: One year (every 12 months)
(Pro)renin receptor
Measured: One year (every 12 months)
Oxidative stress
Measured: One year (every 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerulonephritis, IGAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kagawa University
- Sponsor type
- University, hospital or other
- Investigators
- Masahito Imanishi, Principal investigator, Osaka City General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184599
- Sponsor's protocol ID
- OCGH-746
- Status last verified
- May 2010
- First submitted
- 16 Aug 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy
- ClinicalTrials.gov ID
- NCT01184599
- Acronym / sponsor ID
- OCGH-746
- Conditions
- Glomerulonephritis, IGA, Hypertension
- Keywords
- Aliskiren, Albuminuria, Angiotensinogen, collagen type IV, Transforming Growth Factor beta, aldosterone, renin, prorenin receptor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kagawa UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Mar 2013 (estimated)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- IgA nephropathy confirmed by renal biopsy
- Hypertension (<= 125/75 mmHg)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aliskiren150 mg/day p.o. | Drug | – |
Primary outcome
Renal function (Creatinine clearance)
Time frame: One year (every 6 months)
Urinary protein
Time frame: One year (every 6 months)
10 secondary outcomes
Urinary angiotensinogen
Time frame: One year (every 6 months)
Urinary type 4 collagen
Time frame: One year (every 6 months)
Urinary Transforming growth factor-beta
Time frame: One year (every 6 months)
High-sensitivity C-reactive protein
Time frame: One year (every 6 months)
Plasma Rennin Activity
Time frame: One year (every 12 months)
Aldosterone
Time frame: One year (every 12 months)
Asymmetric dimethylarginine
Time frame: One year (every 12 months)
Advanced glycation end product
Time frame: One year (every 12 months)
(Pro)renin receptor
Time frame: One year (every 12 months)
Oxidative stress
Time frame: One year (every 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masahito Imanishi principal investigator
Osaka City General Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aliskiren in people with Glomerulonephritis, IGA and Hypertension, run by Kagawa University at 4 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Masahito Imanishi (+81-6-6929-1221, masachan@msic.med.osaka-cu.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function (Creatinine clearance) (time frame: One year (every 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.