Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-12-31

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.

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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.

Conditions

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IgA Nephropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aliskiren

Group Type EXPERIMENTAL

Aliskiren

Intervention Type DRUG

Titrate from 150 mg daily to 300 mg daily

Interventions

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Aliskiren

Titrate from 150 mg daily to 300 mg daily

Intervention Type DRUG

Other Intervention Names

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Rasilez

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No