Renal Function DisorderPhase 3NCT00936923
Effect of Diuretics on Fluid Status Control and Residual Renal Function in Peritoneal Dialysis Patients
A Phase 3 study testing furosemide in people with Renal Function Disorder, run by Sun Yat-sen University at 1 site in China.
Trial summary
A prospective, randomized, open-label, stratified, controlled clinical trial to evaluate whether long term furosemide therapy (1 year) would preserve urine volume and/or residual renal function (RRF) and improve fluid state in continuous ambulatory peritoneal dialysis (CAPD) patients. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Renal Function Disorder
- What is being tested?
- furosemide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jun 2008to Dec 2012
- Phase
- Phase 3
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to sign an informed consent
- Age:20~70 years, regardless of gender
- All patients received CAPD more than 1 months;
- Urine volume of 500ml/d or more;
- No history of taking furosemide for at least 2 weeks .
Who cannot join
- Inability or unwillingness to sign the informed consent
- Inability or unwillingness to meet the scheme demands raised by the investigators
- Current acute infection such as peritonitis ;
- Severe diarrhea or vomiting within the preceding 1 month
- Acute Cardiac failure
- Myocardial infarction within the preceding 6 months;
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- Hypertensive encephalopathy or cerebrovascular accident;
- Accident within the preceding 6 months;
- Any condition, such as alcohol or drug abuse, chronic liver disease, malignant disease, or psychiatric disorder;
- Allergy or intolerance to furosemide .
- Current or recent (within 2 weeks) exposure to any other investigational drugs
Trial locations and contacts
1 site in 1 country.
China1 site
The 1st Affiliated Hospital, Sun Yet-sen University
Guangzhou, Guangdong, 510080
About this study
A prospective, randomized, open-label, stratified, controlled clinical trial to evaluate whether long term furosemide therapy (1 year) would preserve urine volume and/or residual renal function (RRF) and improve fluid state in continuous ambulatory peritoneal dialysis (CAPD) patients.
Read the detailed description
There are 3 phases in this study. Phase 1 is screening phase. Each subject will be evaluated to determine if he/she is eligible for the study. Phase 2 is the intervention phage. Patients are divided arbitrarily into two groups according to baseline RRF (residual glomerular filtration rate [rGFR] <5or > 5 ml/min), then randomly received 12 months treatment with the study drugs( furosemide 120mg daily, 60mg daily, or no diuretic). Phase 3 is following-up phase, which lasts 1 year. Dialytic prescription is adjusted independent of the study and is guided by clinical parameters and calculated clearances (target creatinine clearance 65L/week, urea clearance Kt/V > 1.7 per week). Blood pressure is measured using an automated blood pressure device, and the target level is 135/85mmHg. The antihypertensive medication is introduced after the body weigh reduced into target level, and the ACEI and /or ARB selection is needed to the cross-sectional design. The hydration state is measured by bioelectrical impedance analysis (BIA).
- Conditions
- Renal Function Disorder
- Being tested
- furosemide
- Keywords
- CAPD, Diuretics, Residual Renal Function, furosemide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
furosemideDrug
Also called Lasix(Diuretics)
patients will take furosemide 60 or 120mg oral per day for 1 years .
| Study group | Role | What they receive |
|---|---|---|
| furosemide1 | Active comparator | Patients will take furosemide 60mg per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months . Receives: Drug: furosemide |
| furosemide 2 | Active comparator | Patients will take 120mg furosemide per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months . Receives: Drug: furosemide |
| control | No intervention | Patients in control group will not take furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual renal function and urine volume
Measured: Every 3 months
Secondary outcomes (1)
Dialysis adequacy, fluid status(BIA parameters: Total body water, ECW/TBW), serum Cystatin C, blood pressure, hospitalization, death from any cause,cardiovascular events, any adverse drug effects
Measured: Every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2011 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: The study was withdrawn prior to enrollment of first participant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Function DisorderStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Qing Yu, Sun Yat-sen University
- Investigators
- Xueqing Yu, MD,PhD, Principal investigator, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936923
- Sponsor's protocol ID
- SYSU-PRGPD-diuretics
- Status last verified
- May 2015
- First submitted
- 9 Jul 2009
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diuretics on Fluid Status Control and Residual Renal Function in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT00936923
- Acronym / sponsor ID
- SYSU-PRGPD-diuretics
- Conditions
- Renal Function Disorder
- Keywords
- CAPD, Diuretics, Residual Renal Function, furosemide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn prior to enrollment of first participant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 10 Jul 2009 (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.
A prospective, randomized, open-label, stratified, controlled clinical trial to evaluate whether long term furosemide therapy (1 year) would preserve urine volume and/or residual renal function (RRF) and improve fluid state in continuous ambulatory peritoneal dialysis (CAPD) patients.
Detailed description
There are 3 phases in this study. Phase 1 is screening phase. Each subject will be evaluated to determine if he/she is eligible for the study. Phase 2 is the intervention phage. Patients are divided arbitrarily into two groups according to baseline RRF (residual glomerular filtration rate [rGFR] <5or > 5 ml/min), then randomly received 12 months treatment with the study drugs( furosemide 120mg daily, 60mg daily, or no diuretic). Phase 3 is following-up phase, which lasts 1 year. Dialytic prescription is adjusted independent of the study and is guided by clinical parameters and calculated clearances (target creatinine clearance 65L/week, urea clearance Kt/V > 1.7 per week). Blood pressure is measured using an automated blood pressure device, and the target level is 135/85mmHg. The antihypertensive medication is introduced after the body weigh reduced into target level, and the ACEI and /or ARB selection is needed to the cross-sectional design. The hydration state is measured by bioelectrical impedance analysis (BIA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| furosemide1 | Active comparator | Drug: furosemidePatients will take furosemide 60mg per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months . |
| furosemide 2 | Active comparator | Drug: furosemidePatients will take 120mg furosemide per day for 1 years and undergo a study assessment at 3, 6, 12, 18, 24 months . |
| control | No intervention | –Patients in control group will not take furosemide |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willingness to sign an informed consent
- Age:20~70 years, regardless of gender
- All patients received CAPD more than 1 months;
- Urine volume of 500ml/d or more;
- No history of taking furosemide for at least 2 weeks .
Key exclusion criteria (11 listed)
- Inability or unwillingness to sign the informed consent
- Inability or unwillingness to meet the scheme demands raised by the investigators
- Current acute infection such as peritonitis ;
- Severe diarrhea or vomiting within the preceding 1 month
- Acute Cardiac failure
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 |
|---|---|---|
| furosemideAlso: Lasix(Diuretics)patients will take furosemide 60 or 120mg oral per day for 1 years . | Drug | furosemide 2, furosemide1 |
Primary outcome
Residual renal function and urine volume
Time frame: Every 3 months
1 secondary outcome
Dialysis adequacy, fluid status(BIA parameters: Total body water, ECW/TBW), serum Cystatin C, blood pressure, hospitalization, death from any cause,cardiovascular events, any adverse drug effects
Time frame: Every 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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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.
Xueqing Yu, MD,PhD principal investigator
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing furosemide in people with Renal Function Disorder, run by Sun Yat-sen University at 1 site in China.
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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 21 May 2015. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Residual renal function and urine volume (time frame: Every 3 months). 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 21 May 2015.