Heavy ProteinuriaPhase 4NCT00200694
Anti-Proteinuric Response to ACEI, ARB and Diuretics Combination.
A Phase 4 study testing ramipril 5 mg + valsartan 80 mg/day,, ramipril 10 mg + valsartan 160 mg/day, and ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide. in people with Heavy Proteinuria, run by Nantes University Hospital at 1 site in France.
Trial summary
Determine the best strategy for proteinuria lowering in patients with proteinuria > 1 g/day receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of diuretic dosage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heavy Proteinuria
- What is being tested?
- ramipril 5 mg + valsartan 80 mg/day,, ramipril 10 mg + valsartan 160 mg/day, and ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide.
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2005to Mar 2007
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- proteinuria > 1 g/day with ramipril 5 + valsartan 80 mg/day for 2 months
- proteinuria changes < 50% on 3 separate dosages over 2 months.
Who cannot join
- age < 18 or > 80 years systolic BP < 110 or ≥ 140 mmHg, serum creatinine > 250 mmole/L
- serum creatinine increase on ramipril + valsartan > 20%
- intolerance to ACEI or ARB
Trial locations and contacts
1 site in 1 country.
About this study
Determine the best strategy for proteinuria lowering in patients with proteinuria > 1 g/day receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of diuretic dosage.
- Conditions
- Heavy Proteinuria
- Being tested
- ramipril 5 mg + valsartan 80 mg/day,, ramipril 10 mg + valsartan 160 mg/day,, ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide.
- Keywords
- Proteinuria, ACEI, ARB, diuretics, blood pressure, renal failure
- Medical subject headings
- Proteinuria, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ramipril 5 mg + valsartan 80 mg/day,Drug
ramipril 10 mg + valsartan 160 mg/day,Drug
ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide.Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionMar 2007
- Study completionMar 2007
Why it stopped: difficulty in patients's inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy ProteinuriaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Vincent LM Esnault, MD PHD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200694
- Sponsor's protocol ID
- BRD 03-5-D
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 4 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Proteinuric Response to ACEI, ARB and Diuretics Combination.
- ClinicalTrials.gov ID
- NCT00200694
- Acronym / sponsor ID
- BRD 03-5-D
- Conditions
- Heavy Proteinuria
- Keywords
- Proteinuria, ACEI, ARB, diuretics, blood pressure, renal failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in patients's inclusion
- Enrolment
- 18 participants
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 20 Sep 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.
Determine the best strategy for proteinuria lowering in patients with proteinuria > 1 g/day receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of diuretic dosage.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- proteinuria > 1 g/day with ramipril 5 + valsartan 80 mg/day for 2 months
- proteinuria changes < 50% on 3 separate dosages over 2 months.
Key exclusion criteria (3 listed)
- age < 18 or > 80 years systolic BP < 110 or ≥ 140 mmHg, serum creatinine > 250 mmole/L
- serum creatinine increase on ramipril + valsartan > 20%
- intolerance to ACEI or ARB
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 |
|---|---|---|
| ramipril 5 mg + valsartan 80 mg/day, | Drug | – |
| ramipril 10 mg + valsartan 160 mg/day, | Drug | – |
| ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: difficulty in patients's inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
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.
Vincent LM Esnault, MD PHD principal investigator
Nantes University Hospital
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 ramipril 5 mg + valsartan 80 mg/day,, ramipril 10 mg + valsartan 160 mg/day, and ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide. in people with Heavy Proteinuria, run by Nantes University Hospital at 1 site in France.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 4 Feb 2009. 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 France. 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 was stopped early (reason given: difficulty in patients's inclusion). Results are not available in the source record.
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.
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 4 Feb 2009.