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

June 23, 2011 updated by: Kagawa University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University, School of Medicine
      • Osaka, Japan, 534-0021
        • Recruiting
        • Department of Internal Medicine, Osaka City General Hospital
        • Contact:
        • Principal Investigator:
          • Masahito Imanishi
      • Osaka, Japan, 550-0015
        • Not yet recruiting
        • Ohno Memorial Hospital
      • Osaka, Japan, 589-8511
        • Recruiting
        • Kinki University, Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Renal function (Creatinine clearance)
Time Frame: One year (every 6 months)
One year (every 6 months)
Urinary protein
Time Frame: One year (every 6 months)
One year (every 6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Urinary angiotensinogen
Time Frame: One year (every 6 months)
One year (every 6 months)
Urinary type 4 collagen
Time Frame: One year (every 6 months)
One year (every 6 months)
Urinary Transforming growth factor-beta
Time Frame: One year (every 6 months)
One year (every 6 months)
High-sensitivity C-reactive protein
Time Frame: One year (every 6 months)
One year (every 6 months)
Plasma Rennin Activity
Time Frame: One year (every 12 months)
One year (every 12 months)
Aldosterone
Time Frame: One year (every 12 months)
One year (every 12 months)
Asymmetric dimethylarginine
Time Frame: One year (every 12 months)
One year (every 12 months)
Advanced glycation end product
Time Frame: One year (every 12 months)
One year (every 12 months)
(Pro)renin receptor
Time Frame: One year (every 12 months)
One year (every 12 months)
Oxidative stress
Time Frame: One year (every 12 months)
One year (every 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kagawa University

Investigators

  • Principal Investigator: Masahito Imanishi, Osaka City General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

August 18, 2010

First Posted (Estimate)

August 19, 2010

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 23, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCGH-746

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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