A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy

Phase 4

• Conditions: Glomerulonephritis, IGA; Hypertension

• Registration Number: NCT01184599
• Lead Sponsor: Kagawa University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-05
• Study Start: 2010-06
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Last Update Submitted: 2011-06-23
• Last Update Posted: 2011-06-27
• Primary Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Renal function (Creatinine clearance)	One year (every 6 months)
Urinary protein	One year (every 6 months)

Secondary Outcome Measures

Name	Time	Method
Urinary type 4 collagen	One year (every 6 months)
Urinary Transforming growth factor-beta	One year (every 6 months)
Urinary angiotensinogen	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)

Trial Locations

Locations (4)

Department of Internal Medicine, Osaka City General Hospital; 🇯🇵 Osaka, Japan

Kurume University, School of Medicine; 🇯🇵 Fukuoka, Japan

Kinki University, Faculty of Medicine; 🇯🇵 Osaka, Japan

Ohno memorial Hospital; 🇯🇵 Osaka, Japan