NCT00461136

Brief Summary

This study will evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

April 16, 2007

Last Update Submit

September 22, 2016

Conditions

Diabetes Type 2

Keywords

Time courseantiproteinuricblood pressurelowering effectinitiation of renin inhibitionAliskiren in Type 2 diabetesincipient and/or established nephropathy

Outcome Measures

Primary Outcomes (1)

  • To evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.

Secondary Outcomes (2)

  • To measure blood pressure changes over time during the onset and offset of effect.

  • To investigate whether there is a change on biomarkers of inflammation and cardiovascular risk.

Interventions

AliskirenDRUG

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and/or female patients from 30-80 years of age with a diagnosis of Type 2 diabetes (WHO criteria).
  • Incipient and established diabetic nephropathy (urinary albumin excretion ≥ 100 mg/day but ≤ 2000 mg/day).
  • Glomerular filtration rate (GFR) ≥ 40 ml/min (estimated using Modification of Diet in Renal Disease (MDRD) formula) in the last 4 months.
  • Female patients must be postmenopausal or must have had a bilateral oophorectomy or must have been surgically sterilized or hysterectomized at least 6 months prior to screening.
  • To be eligible patients must fulfill the following criteria: Patients on ongoing hypertensive therapy must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at baseline (Day -1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to baseline (Day -1).; Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at baseline (Day -1).
  • Patients must be on stable hypoglycemic medications for at least 8 weeks prior to Visit 2 ( Day -1).
  • Patients must be willing and medically able to discontinue all Angiotensin-converting enzyme inhibitor (ACEI), Angiotensin receptor blocker (ARB), aldosterone receptor antagonist and potassium sparing diuretic medications for the duration of the study.
  • Oral body temperature within the range 35.0-37.5 °C
  • Able to provide written informed consent prior to study participation. .
  • Able to communicate well with the investigator and comply with the requirements of the study.

You may not qualify if:

  • Severe Hypertension Grade 3 WHO classification (Mean Sitting Diastolic Blood Pressure (MSDBP) 110 mmHg and/or Mean Sitting Systolic Blood Pressure MSSBP 180 mmHg)
  • Acetylsalicyclic acid (ASA) treatment \>1g/day or regular use of Non steroidal anti-inflammatory drug (NSAIDs)
  • Kidney disease not caused by diabetes or hypertension
  • Serum potassium \< 3.5 or \> 5.1 mEq/L
  • GFR \< 40 ml/min/1.73m2 as measured by the MDRD formula
  • Serum albumin \< 2.0mg/dL
  • History of hypertensive encephalopathy or cerebrovascular accident at any time prior to Visit1.
  • Current diagnosis of heart failure (New York Heart Association (NYHA) Class II-IV)
  • History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1
  • Second or third degree heart block without a pacemaker
  • Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
  • Clinically significant valvular heart disease
  • Type 1 diabetes mellitus
  • Uncontrolled Type II diabetes mellitus (Hemaglobin subtype A1C (HbA1C) \>11 %)
  • History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Gentofte Municipality, 2820, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Novartis

    Investigative site

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 16, 2007

First Posted

April 17, 2007

Study Start

August 1, 2005

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

DK(1)