Diabetic NephropathyPhase 4NCT00317954
Spironolactone in Diabetic Nephropathy
A Phase 4 study testing Spironolactone 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 evaluate the renoprotective effect (i.e. albuminuria- and bloodpressure lowering effect) of spironolactone 25 mg o.d. in type 1 and type 2 diabetic patients with albuminuria despite recommended antihypertensive treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Spironolactone
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2003to Jul 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes Mellitus
- Diabetic Nephropathy
- Glomerular filtration rate > 30 ml/min/1.73 m2
- Blood pressure > 130/80 mm Hg
Who cannot join
- Child bearing potential
- Plasma-potassium >4.5 mmol/l
- Breastfeeding
- Abuse of alcohol or drugs
- Non-diabetic kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study was to evaluate the renoprotective effect (i.e. albuminuria- and bloodpressure lowering effect) of spironolactone 25 mg o.d. in type 1 and type 2 diabetic patients with albuminuria despite recommended antihypertensive treatment.
- Conditions
- Diabetic Nephropathy
- Being tested
- Spironolactone
- Keywords
- Diabetic nephropathy, Spironolactone, Aldosterone antagonism, Renoprotection
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in albuminuria
Changes in blood pressure
Secondary outcomes (1)
Changes in glomerular filtration rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startSep 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Crossover
- Masking
- Double blind
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Hans-Henrik Parving, MD,DMSc,Prof, Study chair, Steno Diabetes Center CopenhagenKatrine J Schjoedt, MD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317954
- Sponsor's protocol ID
- 2612-2233
- Status last verified
- Aug 2005
- First submitted
- 21 Apr 2006
- Last updated
- 25 Apr 2006
- Results posted
- No
Publications
Schjoedt KJ, Rossing K, Juhl TR, Boomsma F, Rossing P, Tarnow L, Parving HH. Beneficial impact of spironolactone in diabetic nephropathy. Kidney Int. 2005 Dec;68(6):2829-36. doi: 10.1111/j.1523-1755.2005.00756.x.
PubMed 16316360Rossing K, Schjoedt KJ, Smidt UM, Boomsma F, Parving HH. Beneficial effects of adding spironolactone to recommended antihypertensive treatment in diabetic nephropathy: a randomized, double-masked, cross-over study. Diabetes Care. 2005 Sep;28(9):2106-12. doi: 10.2337/diacare.28.9.2106.
PubMed 16123474
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spironolactone in Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00317954
- Acronym / sponsor ID
- 2612-2233
- Conditions
- Diabetic Nephropathy
- Keywords
- Diabetic nephropathy, Spironolactone, Aldosterone antagonism, Renoprotection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Jul 2005
- First posted
- 25 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 evaluate the renoprotective effect (i.e. albuminuria- and bloodpressure lowering effect) of spironolactone 25 mg o.d. in type 1 and type 2 diabetic patients with albuminuria despite recommended antihypertensive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetes Mellitus
- Diabetic Nephropathy
- Glomerular filtration rate > 30 ml/min/1.73 m2
- Blood pressure > 130/80 mm Hg
Key exclusion criteria (5 listed)
- Child bearing potential
- Plasma-potassium >4.5 mmol/l
- Breastfeeding
- Abuse of alcohol or drugs
- Non-diabetic kidney disease
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 |
|---|---|---|
| Spironolactone | Drug | – |
Primary outcome
Changes in albuminuria
Changes in blood pressure
1 secondary outcome
Changes in glomerular filtration 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 25 Apr 2006.
- Results publication: PubMed 16316360Schjoedt KJ, Rossing K, Juhl TR, Boomsma F, Rossing P, Tarnow L, Parving HH. Beneficial impact of spironolactone in diabetic nephropathy. Kidney Int. 2005 Dec;68(6):2829-36. doi: 10.1111/j.1523-1755.2005.00756.x.
- Results publication: PubMed 16123474Rossing K, Schjoedt KJ, Smidt UM, Boomsma F, Parving HH. Beneficial effects of adding spironolactone to recommended antihypertensive treatment in diabetic nephropathy: a randomized, double-masked, cross-over study. Diabetes Care. 2005 Sep;28(9):2106-12. doi: 10.2337/diacare.28.9.2106.
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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.
Hans-Henrik Parving, MD,DMSc,Prof study chair
Steno Diabetes Center Copenhagen
Katrine J Schjoedt, MD principal investigator
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 Spironolactone 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 4 inclusion and 5 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 25 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?
Changes in albuminuria. The study lists 2 primary outcomes in all. 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 NCT00317954, which also lists 2 linked publications.
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 25 Apr 2006.