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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Kagawa University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kagawa University
ClinicalTrials.gov Identifier:
NCT01184599
First received: August 16, 2010
Last updated: June 23, 2011
Last verified: May 2010
History of Changes
  Purpose

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 Intervention Phase
Glomerulonephritis, IGA
Hypertension
 Drug: aliskiren
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Aliskiren
U.S. FDA Resources

Further study details as provided by Kagawa University:

Primary Outcome Measures:
  • Renal function (Creatinine clearance) [ Time Frame: One year (every 6 months) ] [ Designated as safety issue: No ]
  • Urinary protein [ Time Frame: One year (every 6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary angiotensinogen [ Time Frame: One year (every 6 months) ] [ Designated as safety issue: No ]
  • Urinary type 4 collagen [ Time Frame: One year (every 6 months) ] [ Designated as safety issue: No ]
  • Urinary Transforming growth factor-beta [ Time Frame: One year (every 6 months) ] [ Designated as safety issue: No ]
  • High-sensitivity C-reactive protein [ Time Frame: One year (every 6 months) ] [ Designated as safety issue: No ]
  • Plasma Rennin Activity [ Time Frame: One year (every 12 months) ] [ Designated as safety issue: No ]
  • Aldosterone [ Time Frame: One year (every 12 months) ] [ Designated as safety issue: No ]
  • Asymmetric dimethylarginine [ Time Frame: One year (every 12 months) ] [ Designated as safety issue: No ]
  • Advanced glycation end product [ Time Frame: One year (every 12 months) ] [ Designated as safety issue: No ]
  • (Pro)renin receptor [ Time Frame: One year (every 12 months) ] [ Designated as safety issue: No ]
  • Oxidative stress [ Time Frame: One year (every 12 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2010
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aliskiren
    150 mg/day p.o.
  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184599

Contacts
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
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            
Kinki University, Faculty of Medicine Recruiting
Osaka, Japan, 589-8511
Ohno memorial Hospital Not yet recruiting
Osaka, Japan, 550-0015
Sponsors and Collaborators
Kagawa University
Investigators
Principal Investigator: Masahito Imanishi Osaka City General Hospital
  More Information

No publications provided

Responsible Party: Hirofumi Hitomi, Kagawa University, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT01184599     History of Changes
Other Study ID Numbers: OCGH-746
Study First Received: August 16, 2010
Last Updated: June 23, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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:
Glomerulonephritis
Glomerulonephritis, IGA
Hypertension
Nephritis
Kidney Diseases
 Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013