Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

This study has been completed.

First Received on April 4, 2006. No Changes Posted

Sponsor:	Steno Diabetes Center
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Kidney Problems

Drug Information available for: Nisoldipine Lisinopril

U.S. FDA Resources

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

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.

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

Additional relevant MeSH terms:

Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nisoldipine
Lisinopril
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012