This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

This study has been completed.
Queen Mary Hospital, Hong Kong
United Christian Hospital
Information provided by:
The University of Hong Kong Identifier:
First received: June 14, 2009
Last updated: July 2, 2015
Last verified: July 2015
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.

Condition Intervention Phase
IgA Nephropathy Drug: Aliskiren Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot Study

Resource links provided by NLM:

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Change of urine protein excretion rate [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Changes in serum creatinine, eGFR, serum potassium and albumin [ Time Frame: 6 months ]

Enrollment: 25
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren Drug: Aliskiren
Titrate from 150 mg daily to 300 mg daily
Other Name: Rasilez

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00922311

Department of Medicine, The University of Hong Kong
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Queen Mary Hospital, Hong Kong
United Christian Hospital
Principal Investigator: Sydney CW Tang, MD The University of Hong Kong
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sydney CW Tang, The University of Hong Kong Identifier: NCT00922311     History of Changes
Other Study ID Numbers: Novartis-ST-01
Study First Received: June 14, 2009
Last Updated: July 2, 2015

Keywords provided by The University of Hong Kong:

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 21, 2017