Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy

July 29, 2009 updated by: Lerdsin General Hospital

Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy

Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown renoprotection whether it was used alone or in combination. Aliskiren is a direct renin inhibitor (DRI) that has shown renal benefits and safety when combined with ARB. However, to date, the safety of add on aliskiren to the combination treatment of ACEI and ARB in diabetic nephropathy patients remains to elucidate.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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

  • Thailand
      • Bangkok, Thailand, 10500
        • Lerdsin General Hospital

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

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type2 diabetes patients
  • Age <30yrs-70yrs>
  • Overt proteinuria (Urinary protein creatinine ratio > 200mg/g 2 times or more during past 6 Mo)
  • Scr < 2.5 mg/dL
  • HbA1C < 7.5
  • Systolic blood pressure > 160 mmHg without antihypertensive drugs or > 140 with antihypertensive drug
  • No history of previous cardiovascular event (Stroke, Myocardial infarction, unstable angina, hospitalization, surgical correction PVD or PVD with claudication)
  • No hospitalization within 1 yr except for elective surgery

Exclusion Criteria:

  • Physical examination found or suspected serious co-morbid (AF, carotid bruit, structural heart disease, cirrhosis and decompensate liver disease)
  • Non adherence to protocol
  • Intolerable to ACEI or ARB during run-in
  • Abnormal liver function test at the run-in period
  • Rapid declining renal function (SCr increase > 40%) during run-in
  • Hyperkalemia (serum K > 5.5 mEq/L at randomization)
  • Malignancy detected o
  • SBP lower than 110 mmHg (at randomization)

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Aliskiren
Drug: Aliskiren 300mg/d
Aliskiren 300mg/d v.s. placebo for 12wk
Other Names:
  • Rasilez (Thailand)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy
Time Frame: 12 wk after randomization
12 wk after randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of systolic blood pressure
Time Frame: 12 wk after randomization
12 wk after randomization
Reduction of proteinuria
Time Frame: 12 wk after randomization
12 wk after randomization
Change in GFR/mo
Time Frame: 12 wk after randomization
12 wk after randomization
Change of Serum prorenin level compare to baseline
Time Frame: 12 wk after randomization
12 wk after randomization
Change of Urinary TGFb1 compare to baseline
Time Frame: 12 wk after randomization
12 wk after randomization

Collaborators and Investigators

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

Sponsor

Lerdsin 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

September 1, 2009

Primary Completion (ANTICIPATED)

July 1, 2010

Study Completion (ANTICIPATED)

September 1, 2010

Study Registration Dates

First Submitted

July 29, 2009

First Submitted That Met QC Criteria

July 29, 2009

First Posted (ESTIMATE)

July 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2009

Last Update Submitted That Met QC Criteria

July 29, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lerdsin 36/52

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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