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A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT01184599
Recruitment Status : Unknown
Verified May 2010 by Kagawa University.
Recruitment status was:  Recruiting
First Posted : August 19, 2010
Last Update Posted : June 27, 2011
Sponsor:
Information provided by:
Kagawa University

Brief Summary:
The purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin inhibitor, on renal function and progress of renal disease in hypertensive patients with IgA nephropathy.

Condition or disease Intervention/treatment Phase
Glomerulonephritis, IGA Hypertension Drug: aliskiren Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2010
Estimated Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren


Intervention Details:
  • Drug: aliskiren
    150 mg/day p.o.


Primary Outcome Measures :
  1. Renal function (Creatinine clearance) [ Time Frame: One year (every 6 months) ]
  2. Urinary protein [ Time Frame: One year (every 6 months) ]

Secondary Outcome Measures :
  1. Urinary angiotensinogen [ Time Frame: One year (every 6 months) ]
  2. Urinary type 4 collagen [ Time Frame: One year (every 6 months) ]
  3. Urinary Transforming growth factor-beta [ Time Frame: One year (every 6 months) ]
  4. High-sensitivity C-reactive protein [ Time Frame: One year (every 6 months) ]
  5. Plasma Rennin Activity [ Time Frame: One year (every 12 months) ]
  6. Aldosterone [ Time Frame: One year (every 12 months) ]
  7. Asymmetric dimethylarginine [ Time Frame: One year (every 12 months) ]
  8. Advanced glycation end product [ Time Frame: One year (every 12 months) ]
  9. (Pro)renin receptor [ Time Frame: One year (every 12 months) ]
  10. Oxidative stress [ Time Frame: One year (every 12 months) ]


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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • IgA nephropathy confirmed by renal biopsy
  • Hypertension (<= 125/75 mmHg)

Exclusion Criteria:

  • Patients who have been treated with angiotensin type 1 receptor blocker or angiotensin-converting enzyme inhibitor within 4 weeks
  • Severe hypertension (<= 180/110 mmHg) or secondary hypertension
  • Patients with history of allergy or adverse effect for aliskiren
  • Renal dysfunction (estimated Glomerular Filtration Rate < 60 mL/min/1.73m2)
  • Pregnancy
  • Patient treated with cyclosporine
  • Hyperkalemia (serum potassium >= 5.6 mmol/L)
  • Autoimmune disease including systemic lupus erythematosus
  • Patients inadequate for the study

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): NCT01184599


Contacts
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Contact: Masahito Imanishi +81-6-6929-1221 masachan@msic.med.osaka-cu.ac.jp
Contact: Hirofumi Hitomi +81-87-891-2125 hitomi@kms.ac.jp

Locations
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Japan
Kurume University, School of Medicine Recruiting
Fukuoka, Japan, 830-0011
Department of Internal Medicine, Osaka City General Hospital Recruiting
Osaka, Japan, 534-0021
Contact: Masahito Imanishi    +81-6-6929-1221    masachan@msic.med.osaka-cu.ac.jp   
Principal Investigator: Masahito Imanishi         
Ohno memorial Hospital Not yet recruiting
Osaka, Japan, 550-0015
Kinki University, Faculty of Medicine Recruiting
Osaka, Japan, 589-8511
Sponsors and Collaborators
Kagawa University
Investigators
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Principal Investigator: Masahito Imanishi Osaka City General Hospital

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Responsible Party: Hirofumi Hitomi, Kagawa University, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01184599     History of Changes
Other Study ID Numbers: OCGH-746
First Posted: August 19, 2010    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: May 2010
Keywords provided by Kagawa University:
Aliskiren
Albuminuria
Angiotensinogen
collagen type IV
Transforming Growth Factor beta
aldosterone
renin
prorenin receptor
des-angiotensin I renin substrate
oxidative stress
advanced glycosylation end-product receptor
N,N-dimethylarginine
Additional relevant MeSH terms:
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Glomerulonephritis
Glomerulonephritis, IGA
Nephritis
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases