Diabetic NephropathyPhase 4NCT00311870
Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy
A Phase 4 study testing nisoldipine and lisinopril in people with Diabetic Nephropathy, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- nisoldipine and lisinopril
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 1993to Apr 1999
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diabetic nephropathy, type 1 diabetes, hypertension
Who cannot join
- child bearing potential, non-diabetic kidney disease, malignancy
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Diabetic Nephropathy
- Being tested
- nisoldipine, lisinopril
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nisoldipineDrug
lisinoprilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
change in glomerular filtration rate from study start to study end
Secondary outcomes (2)
blood pressure response
change in urinary albumin excretion rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startMar 1993
- Study completionApr 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 52 participants
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Peter Rossing, MD, Principal investigator, Steno Diabetes Center CopenhagenHans-Henrik Parving, MD, Study chair, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311870
- Sponsor's protocol ID
- KA 92126
- Status last verified
- Apr 1999
- First submitted
- 4 Apr 2006
- Last updated
- 6 Apr 2006
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renoprotective Effect of Nisoldipine and Lisinopril in Type 1 Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00311870
- Acronym / sponsor ID
- KA 92126
- Conditions
- Diabetic Nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Mar 1993
- Study completion
- Apr 1999
- First posted
- 6 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- diabetic nephropathy, type 1 diabetes, hypertension
Key exclusion criteria (1 listed)
- child bearing potential, non-diabetic kidney disease, malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nisoldipine | Drug | – |
| lisinopril | Drug | – |
Primary outcome
change in glomerular filtration rate from study start to study end
2 secondary outcomes
blood pressure response
change in urinary albumin excretion rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2006.
- Results publication: PubMed 11128341Tarnow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rossing, MD principal investigator
Steno Diabetes Center Copenhagen
Hans-Henrik Parving, MD study chair
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nisoldipine and lisinopril in people with Diabetic Nephropathy, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in glomerular filtration rate from study start to study end. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00311870, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2006.