CClinicalTrials.gg
CompletedNCT00311870Updated Apr 6, 2006

Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy

A Phase 4 interventional study of nisoldipine and lisinopril in Diabetic Nephropathy, sponsored by Steno Diabetes Center Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2006-04-06.

Sponsored by Steno Diabetes Center Copenhagen · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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

02

Conditions studied

  • Diabetic Nephropathy
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 52 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Steno Diabetes Center Copenhagen is the lead sponsor of 111 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diabetic nephropathy, type 1 diabetes, hypertension

Exclusion criteria

Exclusion Criteria:

  • child bearing potential, non-diabetic kidney disease, malignancy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
52 participants

Interventions

  • Drugnisoldipine
  • Druglisinopril
06

What researchers measure

Primary outcomes

  1. change in glomerular filtration rate from study start to study end

Secondary outcomes

  1. blood pressure response

  2. change in urinary albumin excretion rate

07

Study locations

1 site
  • Steno Diabetes Center
    Gentofte, DK-2820, Denmark
08

References and documents

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. doi: 10.2337/diacare.23.12.1725. PubMed 11128341 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00311870
Lead sponsor
Steno Diabetes Center Copenhagen
Collaborators
Bayer
First posted
Apr 6, 2006
Start date
Mar 1993
Completion
Apr 1999
Last update
Apr 6, 2006

Study contacts

Peter Rossing, MD
principal investigator · Steno Diabetes Center Copenhagen
Hans-Henrik Parving, MD
study chair · Steno Diabetes Center Copenhagen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 1999. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion