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Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

nisoldipine

lisinopril

About this trial

This is an interventional treatment trial for Diabetic Nephropathy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: diabetic nephropathy, type 1 diabetes, hypertension Exclusion Criteria: child bearing potential, non-diabetic kidney disease, malignancy

Sites / Locations

Steno Diabetes Center

Outcomes

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

Full Information

NCT ID

NCT00311870

First Posted

April 4, 2006

Last Updated

April 4, 2006

Sponsor

Steno Diabetes Center Copenhagen

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00311870

Brief Title

Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

Study Type

Interventional

2. Study Status

Record Verification Date

April 1999

Overall Recruitment Status

Completed

Study Start Date

March 1993 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 1999 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Steno Diabetes Center Copenhagen

Collaborators

Bayer

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

52 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

nisoldipine

Intervention Type

Drug

Intervention Name(s)

lisinopril

Primary Outcome Measure Information:

Title

change in glomerular filtration rate from study start to study end

Secondary Outcome Measure Information:

Title

blood pressure response

Title

change in urinary albumin excretion rate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diabetic nephropathy, type 1 diabetes, hypertension Exclusion Criteria: child bearing potential, non-diabetic kidney disease, malignancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Rossing, MD

Organizational Affiliation

Steno Diabetes Center Copenhagen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hans-Henrik Parving, MD

Organizational Affiliation

Steno Diabetes Center Copenhagen

Official's Role

Study Chair

Facility Information:

Facility Name

Steno Diabetes Center

City

Gentofte

ZIP/Postal Code

DK-2820

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

11128341

Citation

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. doi: 10.2337/diacare.23.12.1725.

Results Reference

result

Learn more about this trial

Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

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