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Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00922311
First Posted: June 17, 2009
Last Update Posted: July 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Queen Mary Hospital, Hong Kong
United Christian Hospital
Information provided by:
The University of Hong Kong
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922311


Locations
China
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
Investigators
Principal Investigator: Sydney CW Tang, MD The University of Hong Kong
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sydney CW Tang, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00922311     History of Changes
Other Study ID Numbers: Novartis-ST-01
First Submitted: June 14, 2009
First Posted: June 17, 2009
Last Update Posted: July 3, 2015
Last Verified: July 2015

Keywords provided by The University of Hong Kong:
Proteinuria

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases