Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

This study has been completed.

First Received: April 4, 2006 No Changes Posted

Sponsors and Collaborators:	Steno Diabetes Center Bayer
Information provided by:	Steno Diabetes Center
ClinicalTrials.gov Identifier:	NCT00311870

Purpose

The aim of the study was to compare the renoprotective effect of a long acting calcium antagonist (nisoldipine) with an angiotensin converting enzyme inhibitor (lisinopril)in type 1 diabetic patients with diabetic kidney disease. In total, 51 patients were randomised to treatment with one of these drugs for 4 years. Changes in kidney function, blood pressure and urinary excretion of albumin were measured every 6 months

Condition	Intervention	Phase
Diabetic Nephropathy	Drug: nisoldipine Drug: lisinopril	Phase IV

MedlinePlus related topics: Diabetes Diabetic Kidney Problems

Drug Information available for: Nisoldipine Lisinopril

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:

change in glomerular filtration rate from study start to study end

Secondary Outcome Measures:

blood pressure response
change in urinary albumin excretion rate

Estimated Enrollment:	52
Study Start Date:	March 1993
Estimated Study Completion Date:	April 1999

Detailed Description:

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diabetic nephropathy, type 1 diabetes, hypertension

Exclusion Criteria:

child bearing potential, non-diabetic kidney disease, malignancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311870

Locations

Denmark
Steno Diabetes Center
Gentofte, Denmark, DK-2820

Sponsors and Collaborators

Steno Diabetes Center

Bayer

Investigators

Principal Investigator:	Peter Rossing, MD	Steno Diabetes Center
Study Chair:	Hans-Henrik Parving, MD	Steno Diabetes Center

More Information

Publications:

Tarnow L, Rossing P, Jensen C, Hansen BV, Parving HH. Long-term renoprotective effect of nisoldipine and lisinopril in type 1 diabetic patients with diabetic nephropathy. Diabetes Care. 2000 Dec;23(12):1725-30.

Study ID Numbers:	KA 92126
Study First Received:	April 4, 2006
Last Updated:	April 4, 2006
ClinicalTrials.gov Identifier:	NCT00311870 History of Changes
Health Authority:	Denmark: Ethics Committee; Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Vasodilator Agents
Nisoldipine
Diabetic Nephropathies
Lisinopril
Diabetes Mellitus
Endocrine System Diseases
Calcium Channel Blockers
Cardiovascular Agents

Antihypertensive Agents
Protease Inhibitors
Calcium, Dietary
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Kidney Diseases
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Vasodilator Agents
Nisoldipine
Diabetic Nephropathies
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Lisinopril
Diabetes Mellitus
Endocrine System Diseases
Calcium Channel Blockers
Enzyme Inhibitors

Cardiovascular Agents
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Protease Inhibitors
Membrane Transport Modulators
Urologic Diseases
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Kidney Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on May 07, 2009