Diabetic NephropathyNCT00240019
Maximizing the Benefit of Renin-Angiotensin Blocking Drugs in Diabetic Renal Disease.
A study testing Addition of furosemide 20 mg oral bid to baseline regimen in people with Diabetic Nephropathy, run by Stanford University at 2 sites in United States.
Trial summary
The angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent (furosemide) will decrease the urine protein, which is a sign of disease, more than an angiotensin converting enzyme inhibitor alone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- Addition of furosemide 20 mg oral bid to baseline regimen
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2003to Apr 2006
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- proteinuria greater than 1 gram/day serum creatinine < 2.6 for men, < 2.0 for women
Who cannot join
- blood pressure which cannot be controlled without a diuretic renal diseases other than diabetic nephropathy other disease which would alter renal function during 6 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente of Northern California, Santa Clara and San Jose
Santa Clara, California, 95051
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Maximizing the Benefit of RAS Blockade in Diabetic Nephropathy
The angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent (furosemide) will decrease the urine protein, which is a sign of disease, more than an angiotensin converting enzyme inhibitor alone.
- Conditions
- Diabetic Nephropathy
- Being tested
- Addition of furosemide 20 mg oral bid to baseline regimen
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of furosemide 20 mg oral bid to baseline regimenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of protein in the urine after 8 weeks of treatment.
Secondary outcomes (1)
The estimated glomerular filtration rate after 8 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startDec 2003
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Timothy W Meyer, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240019
- Sponsor's protocol ID
- R01-063011
- Other IDs
- R01DK063011
- Status last verified
- Jun 2006
- First submitted
- 13 Oct 2005
- Last updated
- 17 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing the Benefit of RAS Blockade in Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT00240019
- Acronym / sponsor ID
- R01-063011
- Conditions
- Diabetic Nephropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Dec 2003
- Study completion
- Apr 2006
- First posted
- 17 Oct 2005 (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 angiotensin converting enzyme inhibitor drugs are now standard therapy for patients with diabetic nephropathy. The hypothesis of this study is that adding a diuretic agent (furosemide) will decrease the urine protein, which is a sign of disease, more than an angiotensin converting enzyme inhibitor alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- proteinuria greater than 1 gram/day serum creatinine < 2.6 for men, < 2.0 for women
Key exclusion criteria (1 listed)
- blood pressure which cannot be controlled without a diuretic renal diseases other than diabetic nephropathy other disease which would alter renal function during 6 months
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 |
|---|---|---|
| Addition of furosemide 20 mg oral bid to baseline regimen | Drug | – |
Primary outcome
The amount of protein in the urine after 8 weeks of treatment.
1 secondary outcome
The estimated glomerular filtration rate after 8 weeks of treatment.
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 17 Oct 2006.
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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.
Timothy W Meyer, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addition of furosemide 20 mg oral bid to baseline regimen in people with Diabetic Nephropathy, run by Stanford University at 2 sites in United States.
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 17 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
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?
The amount of protein in the urine after 8 weeks of treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2006.