Rationale and Design for Shiga Microalbuminuria Reduction Trial

April 27, 2006 updated by: Shiga University

The Reduction of Microalbuminuria in Japanese Hypertensive Subjects With Type 2 Diabetes Mellitus Treated With Valsartan or Amlodipine: Study Design for the Shiga Microalbuminuria Reduction Trial (SMART)

The purpose of this trial are to evaluate the reduction of urinary albumin excretion by an angiotensin receptor blocker (ARB), valsartan, in comparison with a calcium channel blocker (CCB), amlodipine, in Japanese hypertensive patients with type 2 diabetes mellitus and microalbuminuria under strict blood pressure control, and to compare the additional effects of an ARB or a CCB in combination with angiotensin-converting enzyme (ACE) inhibitor treatment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Microalbuminuria in diabetic patients is an established risk marker for the progression of diabetic nephropathy and for cardiovascular mortality. Intervention trials have demonstrated that drugs that blockade the renin-angiotensin system can reduce microalbuminuria in Caucasian patients with type 2 diabetes mellitus and microalbuminuria, regardless of blood pressure level. However, it remains uncertain whether angiotensin receptor blockers or calcium channel blockers give a greater reduction of microalbuminuria. The Shiga Microalbuminuria Reduction Trial (SMART) is a prospective, multicentre, randomized, active-controlled, two-arm parallel treatment group comparison study aimed at evaluating reduction of microalbuminuria in 160 Japanese hypertensive patients with type 2 diabetes mellitus and microalbuminuria. The trial consists of an 8-week observation period for screening and washout, and a 24-week intervention period. After the observation period, patients are randomized to either amlodipine 5 mg once daily or valsartan 80 mg once daily as an initial dose. After four weeks, if patients cannot achieve the target blood pressure (<130/80 mmHg) with the initial dose of a study drug, doses are titrated up to amlodipine 10 mg once daily or valsartan 160 mg once daily. The primary endpoints are a change in the rate of urinary albumin excretion from baseline, a normalization of microalbuminuria, and a 50% reduction in urinary albumin excretion from baseline, which are compared between treatment groups. This study will provide additional data for the treatment of hypertension and microalbuminuria and has important health care implications for Japanese patients with type 2 diabetes.

Study Type

Interventional

Enrollment

160

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 Contact

Study Contact Backup

Study Locations

  • Japan
    • Shiga
      • Otsu, Shiga, Japan, 520-2192
        • Recruiting
        • Shiga University of Medical Science
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hiroshi Maegawa
        • Principal Investigator:
          • Yasuo Kida
        • Principal Investigator:
          • Shu Yamada
        • Principal Investigator:
          • Masataka Nishimura
        • Principal Investigator:
          • Tetsuro Arimura
        • Principal Investigator:
          • Noriko Takahara
        • Principal Investigator:
          • Katsuya Egawa
        • Principal Investigator:
          • Masanori Iwanishi
        • Principal Investigator:
          • Toshiki Fujita
        • Principal Investigator:
          • Aya Kadota

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

33 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hypertensive patient with type 2 diabetes
  • Microalbuminuria defined as a urinary albumin excretion of 30 to 300 mg/gCr

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Pregnant women and women of childbearing potential
  • Severe hypertension (> 180/110 mmHg), malignant hypertension, secondary hypertension
  • History of cardiovascular diseases in the preceding 6 months (including symptomatic heart failure, unstable angina, myocardial infarction, the performance of percutaneous transluminal coronary angioplasty [PTCA], or coronary artery bypass graft [CABG], severe arrhythmia, or second or third degree atrioventricular [AV] block)
  • History of clinically significant valvular disease (e.g., aortic stenosis, mitral insufficiency)
  • History of cerebral infarction, cerebral hemorrhage, or transient ischemic attack
  • Serum creatinine level >1.5 mg/dl
  • Persistent hematuria
  • Serum potassium > 5.6 mEq/L (hyperkalemia)
  • Severe hepatic disorder (e.g., hepatic failure, hepatic cirrhosis)
  • Complication of an allergy of potential clinical concern
  • Hypersensitivity to ARBs or CCBs
  • Gastrointestinal surgery or gastrointestinal disorders which could interfere with drug absorption
  • Autoimmune disease
  • Participation in any intervention trial within 3 months prior to the observation period
  • Patients who are unwilling or unable to comply with the trial protocol
  • Concomitant use of other ARBs, CCBs, or potassium-retaining diuretics

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
A change in the rate of urinary albumin excretion (UAE) from the baseline to the end of study
A normalization of microalbuminuria (normoalbuminuria)
A 50% reduction in UAE from the baseline

Secondary Outcome Measures

Outcome Measure
A change in urinary type IV collagen from the baseline to the end of the intervention period
A change in high sensitivity C-reactive protein (hsCRP) from the baseline to the end of the intervention period

Collaborators and Investigators

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

Sponsor

Shiga University

Investigators

  • Study Chair: Atsunori Kashiwagi, Professor, Shiga University of Medical Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2003

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

April 27, 2006

Last Update Submitted That Met QC Criteria

April 27, 2006

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART001

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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