Hypertension Clinical Trial
| NCT number | NCT01184599 |
| Other study ID # | OCGH-746 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 4 |
| First received | August 16, 2010 |
| Last updated | June 23, 2011 |
| Start date | June 2010 |
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.
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years to 75 Years |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Kurume University, School of Medicine | Fukuoka | |
| Japan | Department of Internal Medicine, Osaka City General Hospital | Osaka | |
| Japan | Kinki University, Faculty of Medicine | Osaka | |
| Japan | Ohno memorial Hospital | Osaka |
| Lead Sponsor | Collaborator |
|---|---|
| Kagawa University |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Renal function (Creatinine clearance) | One year (every 6 months) | No | |
| Primary | Urinary protein | One year (every 6 months) | No | |
| Secondary | Urinary angiotensinogen | One year (every 6 months) | No | |
| Secondary | Urinary type 4 collagen | One year (every 6 months) | No | |
| Secondary | Urinary Transforming growth factor-beta | One year (every 6 months) | No | |
| Secondary | High-sensitivity C-reactive protein | One year (every 6 months) | No | |
| Secondary | Plasma Rennin Activity | One year (every 12 months) | No | |
| Secondary | Aldosterone | One year (every 12 months) | No | |
| Secondary | Asymmetric dimethylarginine | One year (every 12 months) | No | |
| Secondary | Advanced glycation end product | One year (every 12 months) | No | |
| Secondary | (Pro)renin receptor | One year (every 12 months) | No | |
| Secondary | Oxidative stress | One year (every 12 months) | No |
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|---|---|---|---|
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