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OpenTrials
Completed

NCT Number: NCT00922311

Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medicine, The University of Hong Kong, Hong Kong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aliskiren

Drug

Titrate from 150 mg daily to 300 mg daily

Other names: Rasilez

Primary outcomes

  1. Change of urine protein excretion rate

    Time frame: 6 months

Secondary outcomes

  1. Changes in serum creatinine, eGFR, serum potassium and albumin

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Queen Mary Hospital, Hong Kong
  • United Christian Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 17, 2009
Registry last updated
Jul 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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