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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

August 16, 2010
June 23, 2011
June 2010
March 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01184599 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy
Not Provided

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.
Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Glomerulonephritis, IGA
  • Hypertension
Drug: aliskiren
150 mg/day p.o.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
March 2013   (final data collection date for primary outcome measure)

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
Both
16 Years to 75 Years
No
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
Japan
 
NCT01184599
OCGH-746
Yes
Hirofumi Hitomi, Kagawa University, Faculty of Medicine
Kagawa University
Not Provided
Principal Investigator: Masahito Imanishi Osaka City General Hospital
Kagawa University
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP