Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

Study Overview
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Brief Summary
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Study objective: To investigate the potential anti-proteinuric efficacy of aliskiren, a novel direct renin inhibitor (DRI), in addition to angiotensin receptor blocker (ARB) in immunoglobulin A nephropathy (IgAN) patients at risk of developing progressive renal failure.

Detailed Description
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This will be an open-label pilot study in which IgAN patients with persistent proteinuria despite maximum dose of ARB treatment will be assigned to receive Aliskiren. There is the optional addition of other anti-hypertensive agents to achieve an optimal target blood pressure of <130/80 mmHg.

Official Title
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Aliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot Study

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: Aliskiren


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 - 70 years of age Histologic diagnosis of IgA nephropathy Proteinuria > 1 g/day or UPC > 1 mg/mg or 113 mg/mmol at least twice Receiving treatment with the maximum dose of ARB for at least 3 months Patients who are willing to give written, informed consent Exclusion Criteria: eGFR < 15 ml/min/1.73 sq.m UPC >5000 mg/g or 570 mg/mmol, or <500 mg/g or 57 mg/mmol Serum K+ > 5.2 mmol/L Presence of bilateral renal artery stenosis Presence of diabetes mellitus Renal histology showing pathologies other than IgAN Known allergy to ARB or DRI Patients on ARB/ACEi combination within 12 weeks of randomization Concurrent treatment with corticosteroids, Nsaid, or immunosuppressant Patients with connective tissue disease or obstructive uropathy Patients with malignancy or conditions severely limiting life expectancy Female who are pregnant or intending to conceive Female of child-bearing age unwilling to practice contraception Patients who are unable to give informed consent Patients simultaneously participating in another study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aliskiren<br> | Drug: Aliskiren<br>* Titrate from 150 mg daily to 300 mg daily<br>* Other names: Rasilez;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of urine protein excretion rate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum creatinine, eGFR, serum potassium and albumin |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proteinuria