Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00922311

Enrollment

Registered

2009-06-17

Start date

2009-07-31

Completion date

2010-12-31

Last updated

2015-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy

Keywords

Proteinuria

Brief summary

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

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.

Interventions

DRUGAliskiren

Titrate from 150 mg daily to 300 mg daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change of urine protein excretion rate	6 months

Secondary

Measure	Time frame
Changes in serum creatinine, eGFR, serum potassium and albumin	6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026