Chronic Kidney DiseasePhase 3FST-IFTANCT02417883
Furosemide Stress Test as a Predictor of Tubular Function in Chronic Kidney Disease
A Phase 3 study testing Furosemide in people with Chronic Kidney Disease, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial summary
In kidney diseases, tubule-interstitium has become much more relevant, as formerly only the glomerulus was considered to have the main importance. Kidney's tubular atrophy and interstitital fibrosis is now recognized as long term prognostic value. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2015to Apr 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Accept to participate (informed consent)
- Legal age or older
- An estimated glomerular filtration rate greater than 15ml/min/1.73m2, calculated by CKD-EPI.
Who cannot join
- Known Alergic reaction to furosemide
- Contraindication to kidney biopsy
- Patient already in renal replacement therapy
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, Mexico City, 14080
Magdalena Madero, MD, madero.magdalena@gmail.com
About this study
Official title: Furosemide Stress Test as a Predictor of Tubular Atrophy and Interstitial Fibrosis in Patients With Chronic Kidney Disease
In kidney diseases, tubule-interstitium has become much more relevant, as formerly only the glomerulus was considered to have the main importance. Kidney's tubular atrophy and interstitital fibrosis is now recognized as long term prognostic value. We aim to evaluate the function of the kidney's tubule-interstitium through furosemide excretion after intravenous administration of this drug, and correlate the rate of excretion of furosemide with interstitial fibrosis findings in scheduled kidney biopsy for patients with chronic kidney disease.
Read the detailed description
All patients scheduled for kidney biopsy will be invited to participate in a standard isovolemic furosemide stress test before the biopsy procedure. The latter will consist in 1.5 miligrams per kilogram of weight of intravenous furosemide administration, with urinary output follow up and measurement. The urinary output will be replaced intravenously with normal saline to avoid dehydration and/or hypotension. A standard 5ml sample of blood will be taken before the test and aliquots of urine before and after furosemide administration will be frozen.
After completion of the formely mentioned test, patients will proceed to their scheduled kidney biopsy along with interventions considered appropiate by their attending physician.
Kidney biopsy sample will be examined by histopathology service and the degree of interstitial fibrosis will be described. The degree of fibrosis will be correlated with the degree furosemide excretion and urinary output.
- Conditions
- Chronic Kidney Disease
- Being tested
- Furosemide
- Keywords
- Furosemide, Interstitial Fibrosis
- Medical subject headings
- Renal Insufficiency, Chronic, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
Evaluate urinary excretion rate fo furosemide
| Study group | Role | What they receive |
|---|---|---|
| Furosemide Stress Test | Experimental | Furosemide stress test will be perform to patients scheduled for kidney bipsy. The test consist in 1.5 miligrams per kilogram of weight of intravenous furosemide administration, along with urinary output follow up and measurement for 6 hours. The urinary output will be replaced intravenously with normal saline to avoid dehydration and/or hypotension. Receives: Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Output
Cuantify urinary output after furosemide administration
Measured: 6 hours
Secondary outcomes (2)
Furosemide excretion rate
Cuantify furosemide excretion in urine
Measured: 6hrs
Interstitial Fibrosis
Measure interstitial fibrosis in kidney biopsy
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez
- Investigators
- Magdalena Madero, MD, Principal investigator, Chief of the Nephrology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417883
- Sponsor's protocol ID
- PT15-920
- Acronym
- FST-IFTA
- Status last verified
- Apr 2015
- First submitted
- 13 Apr 2015
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boor P, Ostendorf T, Floege J. Renal fibrosis: novel insights into mechanisms and therapeutic targets. Nat Rev Nephrol. 2010 Nov;6(11):643-56. doi: 10.1038/nrneph.2010.120. Epub 2010 Sep 14.
PubMed 20838416Burns WC, Kantharidis P, Thomas MC. The role of tubular epithelial-mesenchymal transition in progressive kidney disease. Cells Tissues Organs. 2007;185(1-3):222-31. doi: 10.1159/000101323.
PubMed 17587828Farris AB, Chan S, Climenhaga J, Adam B, Bellamy CO, Seron D, Colvin RB, Reeve J, Mengel M. Banff fibrosis study: multicenter visual assessment and computerized analysis of interstitial fibrosis in kidney biopsies. Am J Transplant. 2014 Apr;14(4):897-907. doi: 10.1111/ajt.12641. Epub 2014 Feb 20.
PubMed 24712330Farris AB, Colvin RB. Renal interstitial fibrosis: mechanisms and evaluation. Curr Opin Nephrol Hypertens. 2012 May;21(3):289-300. doi: 10.1097/MNH.0b013e3283521cfa.
PubMed 22449945van der Voort PH, Boerma EC, Pickkers P. The furosemide stress test to predict renal function after continuous renal replacement therapy. Crit Care. 2014 May 14;18(3):429. doi: 10.1186/cc13871. No abstract available.
PubMed 25033085Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.
PubMed 24053972Rivero J, Rodriguez F, Soto V, Macedo E, Chawla LS, Mehta RL, Vaingankar S, Garimella PS, Garza C, Madero M. Furosemide stress test and interstitial fibrosis in kidney biopsies in chronic kidney disease. BMC Nephrol. 2020 Mar 6;21(1):87. doi: 10.1186/s12882-020-01721-z.
PubMed 32143585
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Furosemide Stress Test as a Predictor of Tubular Atrophy and Interstitial Fibrosis in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02417883
- Acronym / sponsor ID
- FST-IFTA / PT15-920
- Conditions
- Chronic Kidney Disease
- Keywords
- Furosemide, Interstitial Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 16 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.
In kidney diseases, tubule-interstitium has become much more relevant, as formerly only the glomerulus was considered to have the main importance. Kidney's tubular atrophy and interstitital fibrosis is now recognized as long term prognostic value. We aim to evaluate the function of the kidney's tubule-interstitium through furosemide excretion after intravenous administration of this drug, and correlate the rate of excretion of furosemide with interstitial fibrosis findings in scheduled kidney biopsy for patients with chronic kidney disease.
Detailed description
All patients scheduled for kidney biopsy will be invited to participate in a standard isovolemic furosemide stress test before the biopsy procedure. The latter will consist in 1.5 miligrams per kilogram of weight of intravenous furosemide administration, with urinary output follow up and measurement. The urinary output will be replaced intravenously with normal saline to avoid dehydration and/or hypotension. A standard 5ml sample of blood will be taken before the test and aliquots of urine before and after furosemide administration will be frozen.
After completion of the formely mentioned test, patients will proceed to their scheduled kidney biopsy along with interventions considered appropiate by their attending physician.
Kidney biopsy sample will be examined by histopathology service and the degree of interstitial fibrosis will be described. The degree of fibrosis will be correlated with the degree furosemide excretion and urinary output.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Furosemide Stress Test | Experimental | Drug: FurosemideFurosemide stress test will be perform to patients scheduled for kidney bipsy. The test consist in 1.5 miligrams per kilogram of weight of intravenous furosemide administration, along with urinary output follow up and measurement for 6 hours. The urinary output will be replaced intravenously with normal saline to avoid dehydration and/or hypotension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Accept to participate (informed consent)
- Legal age or older
- An estimated glomerular filtration rate greater than 15ml/min/1.73m2, calculated by CKD-EPI.
Key exclusion criteria (3 listed)
- Known Alergic reaction to furosemide
- Contraindication to kidney biopsy
- Patient already in renal replacement therapy
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 |
|---|---|---|
| FurosemideEvaluate urinary excretion rate fo furosemide | Drug | Furosemide Stress Test |
Primary outcome
Urinary Output
Time frame: 6 hours
Cuantify urinary output after furosemide administration
2 secondary outcomes
Furosemide excretion rate
Time frame: 6hrs
Interstitial Fibrosis
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
- Background: PubMed 20838416Boor P, Ostendorf T, Floege J. Renal fibrosis: novel insights into mechanisms and therapeutic targets. Nat Rev Nephrol. 2010 Nov;6(11):643-56. doi: 10.1038/nrneph.2010.120. Epub 2010 Sep 14.
- Background: PubMed 17587828Burns WC, Kantharidis P, Thomas MC. The role of tubular epithelial-mesenchymal transition in progressive kidney disease. Cells Tissues Organs. 2007;185(1-3):222-31. doi: 10.1159/000101323.
- Background: PubMed 24712330Farris AB, Chan S, Climenhaga J, Adam B, Bellamy CO, Seron D, Colvin RB, Reeve J, Mengel M. Banff fibrosis study: multicenter visual assessment and computerized analysis of interstitial fibrosis in kidney biopsies. Am J Transplant. 2014 Apr;14(4):897-907. doi: 10.1111/ajt.12641. Epub 2014 Feb 20.
- Background: PubMed 22449945Farris AB, Colvin RB. Renal interstitial fibrosis: mechanisms and evaluation. Curr Opin Nephrol Hypertens. 2012 May;21(3):289-300. doi: 10.1097/MNH.0b013e3283521cfa.
- Background: PubMed 25033085van der Voort PH, Boerma EC, Pickkers P. The furosemide stress test to predict renal function after continuous renal replacement therapy. Crit Care. 2014 May 14;18(3):429. doi: 10.1186/cc13871. No abstract available.
- Results publication: PubMed 24053972Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.
- Derived from this study: PubMed 32143585Rivero J, Rodriguez F, Soto V, Macedo E, Chawla LS, Mehta RL, Vaingankar S, Garimella PS, Garza C, Madero M. Furosemide stress test and interstitial fibrosis in kidney biopsies in chronic kidney disease. BMC Nephrol. 2020 Mar 6;21(1):87. doi: 10.1186/s12882-020-01721-z.
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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.
Magdalena Madero, MD principal investigator
Chief of the Nephrology Department
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 Chronic Kidney Disease, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
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 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: status not confirmed, as of the sponsor's last update on 16 Apr 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magdalena Madero, MD (+55-5573-2911 ext. 1262, madero.magdalena@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Output (time frame: 6 hours). 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 NCT02417883, which also lists 7 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 16 Apr 2015.