Skip to main content
OpenTrials
Completed

NCT Number: NCT00212901

High Dose Ace Inhibitor Therapy Versus Combination of ACE and ARB Therapy

Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Early diabetic nephropathy as defined by proteinuria between 500mg/24hr and 3g/24hr and GFR>50ml/min (as calculated by the Cockcroft-Gault formula), in the absence of clinical and laboratory evidence of other non-diabetic renal disease.
  • Controlled blood pressure (<150/<90)
  • Able to give informed consent
  • Between the ages of 18 and 75
  • Must be capable of providing a 24 hour urine collection
  • Negative BHcG test for ruling out pregnancy in women of childbearing age
  • Currently taking an angiotensin converting enzyme inhibitor

-

Exclusion criteria

  • Creatinine clearance <50ml/min or 24hour protein excretion >3gm/d.
  • Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp <100mmHg.
  • Serum potassium >5.5 on two separate occasions in the previous six months
  • Previous adverse reaction to angiotensin receptor antagonist medication
  • Use of NSAIDS including COX2 inhibitors
  • Pregnant or nursing women will be excluded
  • Currently taking an angiotensin receptor antagonist

-

Treatment and study plan

High dose ACE-I vs ARB

Drug

Primary outcomes

  1. reducing proteinuria

Secondary outcomes

  1. glomerular filtration rate

  2. side-effects of hypotension, postural symptom

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

Addition of Angiotensin Receptor Blockade to ACE Inhibition Versus High Dose ACE Inhibition for Reduction of Proteinuria in Patients With Diabetic Nephropathy

Important dates

Study start
2004
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Jul 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.