Chronic Kidney DiseasePhase 4NCT00478543
Loop Diuretics in Chronic Kidney Disease
A Phase 4 study testing Furosemide in people with Chronic Kidney Disease, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
The purpose of this study is to verify the efficacy of diuretic therapy on blood pressure control and left ventricular mass in patients affected by chronic kidney disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Furosemide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2005to Jul 2008
- 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
- Chronic renal insufficiency in stage CKD 3 and 4 (GFR 60-15 ml/min/m2) estimated by Cockcroft-Gault formula corrected for body surface
- Systolic blood pressure >140 mmHg in treatment with at least 1 class of antihypertensive drugs
- Patients not in treatment from at least one month with loop diuretics
Who cannot join
- Loop diuretics treatment
- Variation of serum creatinine >30% in the last 3 months
- Steroid therapy and/or cytotoxic agents
- Edema syndromes (Nephrotic syndrome, cirrhosis, heart failure NYHA class 3 or 4)
- Neoplasia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Loop Diuretics Treatment on Blood Pressure Control in Phase 3-4 of Chronic Kidney Disease
The purpose of this study is to verify the efficacy of diuretic therapy on blood pressure control and left ventricular mass in patients affected by chronic kidney disease
Read the detailed description
In CKD, impairment of renal function causes fluid and sodium retention and consequently expansion of extracellular volume, which corresponds to about 5% of body weight in absence of peripheral edema. In particular, sodium retention increases exponentially as glomerular filtration rate declines and is of primary importance in the pathogenesis of hypertension. Therefore, reduction of salt intake in renal patients allows a better blood pressure control. Despite the evidence collected on the beneficial effects of salt restriction in CKD, compliance with dietary prescription is generally poor in patients followed up in the real world of clinical practice. In the presence of poor adherence to salt restriction, diuretics agents become the cornerstone of treatment of hypertension secondary to CKD. Disappointingly, nephrologists are reluctant to "adequately" use loop diuretics in their hypertensive CKD patients, probably because of the fear of side effects and of the amazing absence in medical literature of studies of middle-long term on diuretic efficacy. Therefore, the primary aim of this study is to evaluate efficacy and safety of loop diuretics on blood pressure control in patients affected by CKD.
- Conditions
- Chronic Kidney Disease
- Being tested
- Furosemide
- Keywords
- Loop diuretics, Chronic Kidney Disease, Hypertension, Blood pressure control, Left ventricular mass
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
| Study group | Role | What they receive |
|---|---|---|
| Diuretic | Experimental | Furosemide Receives: Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography
Measured: 6 months and 1 year respectively
Secondary outcomes (1)
Adverse drug reactions, ambulatory blood pressure measure control, body volumes evaluated by bioimpedance analysis, expense of time and resources in follow-up of patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2007 (estimated)
- Study startSep 2005
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Investigators
- Giuseppe Conte, Professor, Study chair, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478543
- Sponsor's protocol ID
- LD1-22052007
- Status last verified
- Feb 2009
- First submitted
- 24 May 2007
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
De Nicola L, Minutolo R, Bellizzi V, Zoccali C, Cianciaruso B, Andreucci VE, Fuiano G, Conte G; investigators of the TArget Blood Pressure LEvels in Chronic Kidney Disease (TABLE in CKD) Study Group. Achievement of target blood pressure levels in chronic kidney disease: a salty question? Am J Kidney Dis. 2004 May;43(5):782-95. doi: 10.1053/j.ajkd.2004.01.009.
PubMed 15112168De Nicola L, Minutolo R, Chiodini P, Zoccali C, Castellino P, Donadio C, Strippoli M, Casino F, Giannattasio M, Petrarulo F, Virgilio M, Laraia E, Di Iorio BR, Savica V, Conte G; TArget Blood Pressure LEvels in Chronic Kidney Disease (TABLE in CKD) Study Group. Global approach to cardiovascular risk in chronic kidney disease: reality and opportunities for intervention. Kidney Int. 2006 Feb;69(3):538-45. doi: 10.1038/sj.ki.5000085.
PubMed 16395261Bellizzi V, Di Iorio BR, De Nicola L, Minutolo R, Zamboli P, Trucillo P, Catapano F, Cristofano C, Scalfi L, Conte G; ERIKA Study-group. Very low protein diet supplemented with ketoanalogs improves blood pressure control in chronic kidney disease. Kidney Int. 2007 Feb;71(3):245-51. doi: 10.1038/sj.ki.5001955. Epub 2006 Oct 11.
PubMed 17035939
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
- Effect of Loop Diuretics Treatment on Blood Pressure Control in Phase 3-4 of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00478543
- Acronym / sponsor ID
- LD1-22052007
- Conditions
- Chronic Kidney Disease
- Keywords
- Loop diuretics, Chronic Kidney Disease, Hypertension, Blood pressure control, Left ventricular mass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 25 May 2007 (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 purpose of this study is to verify the efficacy of diuretic therapy on blood pressure control and left ventricular mass in patients affected by chronic kidney disease
Detailed description
In CKD, impairment of renal function causes fluid and sodium retention and consequently expansion of extracellular volume, which corresponds to about 5% of body weight in absence of peripheral edema. In particular, sodium retention increases exponentially as glomerular filtration rate declines and is of primary importance in the pathogenesis of hypertension. Therefore, reduction of salt intake in renal patients allows a better blood pressure control. Despite the evidence collected on the beneficial effects of salt restriction in CKD, compliance with dietary prescription is generally poor in patients followed up in the real world of clinical practice. In the presence of poor adherence to salt restriction, diuretics agents become the cornerstone of treatment of hypertension secondary to CKD. Disappointingly, nephrologists are reluctant to "adequately" use loop diuretics in their hypertensive CKD patients, probably because of the fear of side effects and of the amazing absence in medical literature of studies of middle-long term on diuretic efficacy. Therefore, the primary aim of this study is to evaluate efficacy and safety of loop diuretics on blood pressure control in patients affected by CKD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diuretic | Experimental | Drug: FurosemideFurosemide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic renal insufficiency in stage CKD 3 and 4 (GFR 60-15 ml/min/m2) estimated by Cockcroft-Gault formula corrected for body surface
- Systolic blood pressure >140 mmHg in treatment with at least 1 class of antihypertensive drugs
- Patients not in treatment from at least one month with loop diuretics
Key exclusion criteria (5 listed)
- Loop diuretics treatment
- Variation of serum creatinine >30% in the last 3 months
- Steroid therapy and/or cytotoxic agents
- Edema syndromes (Nephrotic syndrome, cirrhosis, heart failure NYHA class 3 or 4)
- Neoplasia
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 |
|---|---|---|
| Furosemide | Drug | Diuretic |
Primary outcome
Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography
Time frame: 6 months and 1 year respectively
1 secondary outcome
Adverse drug reactions, ambulatory blood pressure measure control, body volumes evaluated by bioimpedance analysis, expense of time and resources in follow-up of patients
Time frame: 6 months
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 4 Feb 2009.
- Background: PubMed 15112168De Nicola L, Minutolo R, Bellizzi V, Zoccali C, Cianciaruso B, Andreucci VE, Fuiano G, Conte G; investigators of the TArget Blood Pressure LEvels in Chronic Kidney Disease (TABLE in CKD) Study Group. Achievement of target blood pressure levels in chronic kidney disease: a salty question? Am J Kidney Dis. 2004 May;43(5):782-95. doi: 10.1053/j.ajkd.2004.01.009.
- Background: PubMed 16395261De Nicola L, Minutolo R, Chiodini P, Zoccali C, Castellino P, Donadio C, Strippoli M, Casino F, Giannattasio M, Petrarulo F, Virgilio M, Laraia E, Di Iorio BR, Savica V, Conte G; TArget Blood Pressure LEvels in Chronic Kidney Disease (TABLE in CKD) Study Group. Global approach to cardiovascular risk in chronic kidney disease: reality and opportunities for intervention. Kidney Int. 2006 Feb;69(3):538-45. doi: 10.1038/sj.ki.5000085.
- Background: PubMed 17035939Bellizzi V, Di Iorio BR, De Nicola L, Minutolo R, Zamboli P, Trucillo P, Catapano F, Cristofano C, Scalfi L, Conte G; ERIKA Study-group. Very low protein diet supplemented with ketoanalogs improves blood pressure control in chronic kidney disease. Kidney Int. 2007 Feb;71(3):245-51. doi: 10.1038/sj.ki.5001955. Epub 2006 Oct 11.
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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.
Giuseppe Conte, Professor study chair
University of Campania Luigi Vanvitelli
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 Furosemide in people with Chronic Kidney Disease, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 3 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 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 Italy. 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?
Attainment of blood pressure target (<130/80 mmHg)and evaluation of left ventricular mass by echocardiography (time frame: 6 months and 1 year respectively). 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 NCT00478543, which also lists 3 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 4 Feb 2009.