NCT00311870

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 1993

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1993

Completed
6.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1999

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2006

Completed
Last Updated

April 6, 2006

Status Verified

April 1, 1999

First QC Date

April 4, 2006

Last Update Submit

April 4, 2006

Conditions

Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

  • change in glomerular filtration rate from study start to study end

Secondary Outcomes (2)

  • blood pressure response

  • change in urinary albumin excretion rate

Interventions

nisoldipineDRUG
lisinoprilDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diabetic nephropathy, type 1 diabetes, hypertension

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, DK-2820, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 11128341RESULT

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

NisoldipineLisinopril

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Peter Rossing, MD

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

  • Hans-Henrik Parving, MD

    Steno Diabetes Center Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2006

First Posted

April 6, 2006

Study Start

March 1, 1993

Study Completion

April 1, 1999

Last Updated

April 6, 2006

Record last verified: 1999-04

Locations

DK(1)