Glomerulonephritis, IGA, Hypertension
Conditions
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
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.
Interventions
DRUGaliskiren
150 mg/day p.o.
Sponsors
Kagawa University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal function (Creatinine clearance) | One year (every 6 months) |
| Urinary protein | One year (every 6 months) |
Secondary
| Measure | Time frame |
|---|---|
| Urinary angiotensinogen | One year (every 6 months) |
| Urinary type 4 collagen | One year (every 6 months) |
| Urinary Transforming growth factor-beta | One year (every 6 months) |
| High-sensitivity C-reactive protein | One year (every 6 months) |
| Plasma Rennin Activity | One year (every 12 months) |
| Aldosterone | One year (every 12 months) |
| Asymmetric dimethylarginine | One year (every 12 months) |
| Advanced glycation end product | One year (every 12 months) |
| (Pro)renin receptor | One year (every 12 months) |
| Oxidative stress | One year (every 12 months) |
Countries
Japan
Contacts
Primary ContactMasahito Imanishi
Backup ContactHirofumi Hitomi
Outcome results
None listed