Nephrotic SyndromePhase 4NCT02427880
Role of Acetazolamide and Hydrochlorothiazide Followed by Furosemide in Treating Nephrotic Edema
A Phase 4 study testing Acetazolamide and Hydrochlorothiazide Followed by Furosemide and Furosemide and Hydrochlorothiazide Followed by Furosemide in people with Nephrotic Syndrome and Edema, run by Shiraz University of Medical Sciences.
Trial summary
The purpose of this study is to determine whether using furosemide following acetazolamide is effective in treating refractory edema associated with nephrotic syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotic Syndrome, Edema
- What is being tested?
- Acetazolamide and Hydrochlorothiazide Followed by Furosemide and Furosemide and Hydrochlorothiazide Followed by Furosemide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jun 2015
- 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
- Having refractory edema due to nephrotic syndrome
- Having GFR>60 ml/min/1.73m2
- Being able to come for weekly visit
- Having the minimum age of 18 years
- Signing the informed consent form
Who cannot join
- Hypokalemia
- Pregnancy
- Renal transplant
- active malignancy or infection
- acidosis
- Using NSAIDs
- Having another causes of edema including liver cirrhosis, heart failure
- Neurologic or psychiatric problem hindering adherence to the study protocol
About this study
Official title: Acetazolamide and Hydrochlorothiazide Followed by Furosemide Versus Hydrochlorothiazide and Furosemide Followed by Furosemide for the Treatment of Adults With Refractory Nephrotic Edema: A Randomized, Double-Blind Trial
The purpose of this study is to determine whether using furosemide following acetazolamide is effective in treating refractory edema associated with nephrotic syndrome.
Read the detailed description
Edema is referred to increase in interstitial fluid that is clinically evident. The main causes of generalized edema are heart failure, renal failure, nephrotic syndrome, glomerulonephritis and chronic liver failure. In some cases, edema is treated by management of the underlying disease. However, in some other cases edema may persist and become more severe that needs adjuvant treatments. Because use of diuretics such as furosemide and hydrochlorothiazide is not completely effective in treating severe refractory edema, use of some other diuretics is also recommended. In this double-blind clinical trial, weight and some lab data including blood urea nitrogen, serum creatinine, serum sodium, serum potassium, serum albumin, urine sodium, urine potassium, 24-hour urine volume, 24-hour urine protein and 24-hour urine creatinine of 20 random adult patients with nephrotic syndrome who have refractory edema and GFR>60 ml/min/1.73m2 and are referred to nephrology clinic of Shiraz University of Medical Sciences will be measured; the patients should not have hypokalemia and other causes of edema such as heart failure or cirrhosis. Then the patients are divided into 2 groups with 10 members in each. The first group will be prescribed 40 mg of furosemide and 50 mg of hydrochlorothiazide and the second one will receive 250 mg of acetazolamide and 50 mg of hydrochlorothiazide daily for 1 week. Then, weight and mentioned lab data will be measured again. After that, all the patients will have 40 mg of furosemide daily for 2 weeks. Then, weight and mentioned lab data will be measured for one more time.
- Conditions
- Nephrotic Syndrome, Edema
- Being tested
- Acetazolamide and Hydrochlorothiazide Followed by Furosemide, Furosemide and Hydrochlorothiazide Followed by Furosemide
- Keywords
- Edema, Nephrotic syndrome, Acetazolamide, Furosemide
- Medical subject headings
- Nephrotic Syndrome, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetazolamide and Hydrochlorothiazide Followed by FurosemideDrug
Also called Diamox Sequels and Microzide Followed by Lasix
Furosemide and Hydrochlorothiazide Followed by FurosemideDrug
Also called Lasix and Microzide Followed by Lasix
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Experimental | Each patient receives 250 mg of acetazolamide and 50 mg of hydrochlorothiazide daily for 1 week. Then they are prescribed 40 mg of furosemide daily for 2 weeks. Receives: Drug: Acetazolamide and Hydrochlorothiazide Followed by Furosemide |
| Furosemide | Active comparator | Each patient is prescribed 40 mg of furosemide and 50 mg of hydrochlorothiazide daily for 1 week. Then they receive 40 mg of furosemide daily for 2 weeks. Receives: Drug: Furosemide and Hydrochlorothiazide Followed by Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weight at the end of third week
Measured: Baseline and at the end of the third week
Secondary outcomes (11)
Change from baseline in systolic and diastolic blood pressure at the end of third week
Measured: Baseline and at the end of the third week
Change from baseline in serum sodium at the end of third week
Measured: Baseline and at the end of the third week
Change from baseline in serum potassium at the end of third week
Measured: Baseline and at the end of the third week
Change from baseline in blood urea nitrogen at the end of third week
Measured: Baseline and at the end of the third week
Change from baseline in serum creatinine at the end of third week
Measured: At the start and at the end of the third week
Change from baseline in serum albumin at the end of third week
Measured: Baseline and at the end of the third week
Change from baseline in urine sodium at the end of third week
Measured: Baseline and at the end of the third week
Change from baseline in urine potassium at the end of third week
Measured: Baseline and at the end of the third week
Change from baseline in 24-hour urine volume at the end of third week
Measured: Baseline and at the end of the third week
Change from baseline in 24-hour urine creatinine at the end of third week
Measured: Baseline and at the end of the third week
Change from baseline in 24-hour urine protein at the end of third week
Measured: Baseline and at the end of the third week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nephrotic SyndromeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Amin Fallahzadeh, Shiraz University of Medical Sciences
- Investigators
- Mohammad Mahdi Sagheb, MD, Study chair, Nephrologist at Shiraz University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427880
- Sponsor's protocol ID
- 7308
- Status last verified
- Feb 2016
- First submitted
- 20 Apr 2015
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Soleimani M. A novel target for diuretic therapy. Iran J Kidney Dis. 2012 Nov;6(6):419-25.
PubMed 23146978
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetazolamide and Hydrochlorothiazide Followed by Furosemide Versus Hydrochlorothiazide and Furosemide Followed by Furosemide for the Treatment of Adults With Refractory Nephrotic Edema: A Randomized, Double-Blind Trial
- ClinicalTrials.gov ID
- NCT02427880
- Acronym / sponsor ID
- 7308
- Conditions
- Nephrotic Syndrome, Edema
- Keywords
- Edema, Nephrotic syndrome, Acetazolamide, Furosemide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Apr 2015 (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 determine whether using furosemide following acetazolamide is effective in treating refractory edema associated with nephrotic syndrome.
Detailed description
Edema is referred to increase in interstitial fluid that is clinically evident. The main causes of generalized edema are heart failure, renal failure, nephrotic syndrome, glomerulonephritis and chronic liver failure. In some cases, edema is treated by management of the underlying disease. However, in some other cases edema may persist and become more severe that needs adjuvant treatments. Because use of diuretics such as furosemide and hydrochlorothiazide is not completely effective in treating severe refractory edema, use of some other diuretics is also recommended. In this double-blind clinical trial, weight and some lab data including blood urea nitrogen, serum creatinine, serum sodium, serum potassium, serum albumin, urine sodium, urine potassium, 24-hour urine volume, 24-hour urine protein and 24-hour urine creatinine of 20 random adult patients with nephrotic syndrome who have refractory edema and GFR>60 ml/min/1.73m2 and are referred to nephrology clinic of Shiraz University of Medical Sciences will be measured; the patients should not have hypokalemia and other causes of edema such as heart failure or cirrhosis. Then the patients are divided into 2 groups with 10 members in each. The first group will be prescribed 40 mg of furosemide and 50 mg of hydrochlorothiazide and the second one will receive 250 mg of acetazolamide and 50 mg of hydrochlorothiazide daily for 1 week. Then, weight and mentioned lab data will be measured again. After that, all the patients will have 40 mg of furosemide daily for 2 weeks. Then, weight and mentioned lab data will be measured for one more time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Experimental | Drug: Acetazolamide and Hydrochlorothiazide Followed by FurosemideEach patient receives 250 mg of acetazolamide and 50 mg of hydrochlorothiazide daily for 1 week. Then they are prescribed 40 mg of furosemide daily for 2 weeks. |
| Furosemide | Active comparator | Drug: Furosemide and Hydrochlorothiazide Followed by FurosemideEach patient is prescribed 40 mg of furosemide and 50 mg of hydrochlorothiazide daily for 1 week. Then they receive 40 mg of furosemide daily for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having refractory edema due to nephrotic syndrome
- Having GFR>60 ml/min/1.73m2
- Being able to come for weekly visit
- Having the minimum age of 18 years
- Signing the informed consent form
Key exclusion criteria (8 listed)
- Hypokalemia
- Pregnancy
- Renal transplant
- active malignancy or infection
- acidosis
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 |
|---|---|---|
| Acetazolamide and Hydrochlorothiazide Followed by FurosemideAlso: Diamox Sequels and Microzide Followed by Lasix | Drug | Acetazolamide |
| Furosemide and Hydrochlorothiazide Followed by FurosemideAlso: Lasix and Microzide Followed by Lasix | Drug | Furosemide |
Primary outcome
Change from baseline in weight at the end of third week
Time frame: Baseline and at the end of the third week
11 secondary outcomes
Change from baseline in systolic and diastolic blood pressure at the end of third week
Time frame: Baseline and at the end of the third week
Change from baseline in serum sodium at the end of third week
Time frame: Baseline and at the end of the third week
Change from baseline in serum potassium at the end of third week
Time frame: Baseline and at the end of the third week
Change from baseline in blood urea nitrogen at the end of third week
Time frame: Baseline and at the end of the third week
Change from baseline in serum creatinine at the end of third week
Time frame: At the start and at the end of the third week
Change from baseline in serum albumin at the end of third week
Time frame: Baseline and at the end of the third week
Change from baseline in urine sodium at the end of third week
Time frame: Baseline and at the end of the third week
Change from baseline in urine potassium at the end of third week
Time frame: Baseline and at the end of the third week
Change from baseline in 24-hour urine volume at the end of third week
Time frame: Baseline and at the end of the third week
Change from baseline in 24-hour urine creatinine at the end of third week
Time frame: Baseline and at the end of the third week
Change from baseline in 24-hour urine protein at the end of third week
Time frame: Baseline and at the end of the third week
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 23 Feb 2016.
- Background: PubMed 23146978Soleimani M. A novel target for diuretic therapy. Iran J Kidney Dis. 2012 Nov;6(6):419-25.
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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.
Mohammad Mahdi Sagheb, MD study chair
Nephrologist at Shiraz University of Medical Science
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetazolamide and Hydrochlorothiazide Followed by Furosemide and Furosemide and Hydrochlorothiazide Followed by Furosemide in people with Nephrotic Syndrome and Edema, run by Shiraz University of Medical Sciences.
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 8 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 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in weight at the end of third week (time frame: Baseline and at the end of the third week). 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 NCT02427880, which also lists 1 linked publication.
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 23 Feb 2016.