Chronic Kidney DiseasesFUROPBUTNCT06750575
Study to Examine the Effect of the Diuretic Furosemide on the Plasma Levels of Toxins and the Removal of Toxins from the Blood in Patients with Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Renal Failure Chronic, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The goal of this observational study is to examine the interaction between the diuretic furosemide and certain toxins called protein-bound uremic toxins (PBUTs) in patients with chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Renal Failure Chronic
- What is being tested?
- Invasive measurements
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Jun 2024to 1 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population will consist of patients with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) of 18 years and older with an indication for starting treatment with furosemide as part of routine patient care. Participants will be recruited at the Department of Nephrology in the University Medical Center Utrecht (UMCU, Utrecht, The Netherlands) who have not yet started furosemide treatment or any renal replacement therapy.
Who may be able to join
- An age of 18 years or older
- An eGFR <60 mL/min/1.73m2 for at least three months (diagnosis of CKD stage 3-5)
- An indication for the start of treatment with furosemide as part of routine patient care
- Willingness to participate in the study and a signed informed consent
Who cannot join
- Patients who are already on furosemide treatment
- Patients with a liver disease with hyperbilirubinemia
- Patients who receive any type of renal replacement therapy (peritoneal dialysis, haemodialysis)
- Patients with end-stage renal failure without residual diuresis
- Patients who will start with medication simultaneously with start of furosemide treatment that might interfere with PBUT excretion or PBUT protein binding
- Patients who are incapacitated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht (UMCU)
Utrecht, Utrecht, 3584 CX
Karin GF Gerritsen, MD, PhD, +31-887557375, k.g.f.gerritsen@umcutrecht.nl
Dian P Bolhuis, MD, MSc, +31-887557375, d.p.bolhuis-3@umcutrecht.nl
About this study
Official title: The Effect of Furosemide on Protein-Bound Uremic Toxin Plasma Levels and Excretion in Patients with Chronic Kidney Disease
The goal of this observational study is to examine the interaction between the diuretic furosemide and certain toxins called protein-bound uremic toxins (PBUTs) in patients with chronic kidney disease (CKD). The main question it aims to answer is: what is the effect of furosemide on plasma levels of PBUTs in patients with CKD? Besides, the investigators will also look at the effect of furosemide on the excretion of PBUTs via the urine.
Participants will be included in the study once they will be prescribed furosemide as part of routine patient care. Before they start with the furosemide treatment, patients will undergo the following:
Read more
- Blood pressure measurement
- Blood sample withdrawal
- Urine sample collection
- 12-hour urine collection
Then, one to four weeks after starting with furosemide treatment, patients will undergo the following:
- Blood pressure measurement
- Blood sample prior to furosemide intake (Tmin)
- Blood sample withdrawal 90 minutes after furosemide intake (Tmax: time at which the highest furosemide plasma level is expected)
- Urine sample collection 60-120 minutes after furosemide intake
- 12-hour urine collection
The investigators expect furosemide to increase plasma levels of PBUTs by decreasing the renal excretion of the toxins.
Read the detailed description
Protein-bound uremic toxins are known to accumulate in chronic kidney disease (CKD) and are associated with increased morbidity and mortality. It is therefore crucial to maintain the PBUT levels low in this patient group. Furosemide is often prescribed to CKD patients. However, based on preclinical data, furosemide could affect the renal excretion of PBUTs, either by competing for binding to albumin or by competing for the secretory system in the kidney. It is important to examine the effect of furosemide on the excretion and plasma concentration PBUTs as this might have harmful consequences for patients with CKD.
This study aims to examine the effect of furosemide PBUT plasma levels in patients with CKD as well as the renal PBUT excretion. The investigators expect furosemide to increase plasma levels of PBUTs by decreasing the renal excretion of the toxins.
This study is observational and includes invasive measurements; a prospective repeated measures cohort study design will be used in which PBUT plasma concentrations and excretion will be determined before and after the start of furosemide treatment.
The study population consists of patients with CKD stage 3-5 (<60 mL/min/1.73m2 for at least three months) who have an indication for furosemide treatment as part of routine patient care. Participants will receive furosemide in a dosage prescribed by their nephrologist as part of their routine patient care; this treatment is not changed by the participation of patients in the study.
A power analysis for a paired samples T-Test was done using GPower (version 3.1.9.4). Data regarding PBUT plasma levels from the study of Tang et al. in 2021 was used in order to calculate the sample size; PCS plasma levels before (average ± standard deviation: 13,481 ± 12,642 nM) and after (average ± standard deviation: 23,000 ± 24,900 nM) furosemide intake were chosen, since PCS is one of the main PBUTs of interest. This calculation showed a required sample size of 34 (one-tail, power = 80%, α = 0.05, d = 0.44, correlation between samples 0.5 based on assumption).
Prior to the start of the furosemide treatment, a blood sample (three tubes/11 mL per withdrawal) and a urine sample will be collected from patients enrolled in the study. Participants will also hand in a 12-hour urine collection and their blood pressure will be measured.
After the start of the furosemide treatment (at least one week after the start of the furosemide treatment so that steady state has been reached), two blood samples, one urine sample, and a 24-hour urine collection will be obtained. Participants will be asked to obtain a 12-hour urine collection and to bring this with them on the day the of the visit. During the visit at the University Medical Center Utrecht, participants will first hand in the 12-hour urine collection and their blood pressure will be measured. Furthermore, a blood sample will be taken prior to the furosemide intake (Tmin). Then, they will take their prescribed furosemide at around the same time as they normally take their medication. 60 minutes after the furosemide intake, participants will be asked to empty their bladder and drink two glasses of water. Then, at Tmax, a blood sample will be collected. Tmax is estimated at around 90 minutes after oral intake; therefore, the target time of sample collection is 90 min with an acceptable range between 60-120 minutes after furosemide intake. Furthermore, a urine sample will be collected between 60 and 120 minutes after furosemide intake in order to best examine the effect of furosemide on PBUT excretion. The exact time of furosemide intake and the time of the blood and urine sample collection will be registered.
The main endpoints of this study are PBUT plasma levels before and 1-4 weeks after the start of furosemide treatment (in a steady state).
Baseline characteristics and study parameters will be presented as either a mean with standard deviation or a median with interquartile range for continuous data, or as a percentage for categorical data. Results with a p<0.05 will be considered statistically significant. Analyses will be done using the statistical software platforms SPSS and R. Missing data will be excluded from the analyses via pairwise deletion.
Participants will only receive furosemide prescribed by their treating nephrologist as part of routine patient care. In addition, three blood sample drawings, two urine samples, and two 12-hour urine collections will be needed. Thus, the risk associated with participation is negligibly low. Participation to the study will include two site visits. These visits will be combined with routine check-ups as much as possible.
- Conditions
- Chronic Kidney Diseases, Renal Failure Chronic
- Being tested
- Invasive measurements
- Keywords
- Furosemide, Drug-toxin interactions, Protein-bound uremic toxins, P-cresyl sulfate, Indoxyl sulfate
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive measurementsDiagnostic test
Blood and urine samples will be collected during the study.
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease stage 3-5 | Participants with an age of 18 years or older and with CKD stage 3-5 (an estimated glomerular filtration rate of 60 mL/min/1.73m^2 or lower for at least three months). Participants need to have an indication to start with furosemide as part of routine patient care. Receives: Diagnostic Test: Invasive measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of the PBUT indoxyl sulfate
Indoxyl sulfate plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Measured: This will be assessed three times during the study participation period (between 1-4 weeks).
Plasma levels of the PBUT p-cresyl sulfate
P-cresyl sulfate plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Measured: This will be assessed three time during the study participation period (between 1-4 weeks).
Plasma levels of the PBUT indole-3-acetic acid
Indole-3-acetic acid plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Measured: This will be assessed three times during the study participation period (between 1-4 weeks).
Plasma levels of the PBUT kynurenic acid
Kynurenic acid plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Measured: This will be assessed three times during the study participation period (between 1-4 weeks).
Plasma levels of the PBUT L-kynurenine
L-kynurenine plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Measured: This will be assessed three times during the study participation period (between 1-4 weeks).
Plasma levels of the PBUT hippuric acid
Hippuric acid plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Measured: This will be assessed three times during the study participation period (between 1-4 weeks).
Plasma levels of the PBUT p-cresyl glucuronide
P-cresyl glucuronide plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Measured: This will be assessed three times during the study participation period (between 1-4 weeks).
Secondary outcomes (6)
Surrogate for PBUT clearance
This will be calculated for seven PBUTs (indoxyl sulfate, p-cresyl sulfate, indole-3-acetic acid, kynurenic acid, L-kynurenine, hippuric acid, p-cresyl glucuronide) before and after start of furosemide treatment using the following formula:
Urine PBUT concentration / (urine creatinine concentration * plasma PBUT concentration)
Measured: This will be assessed three times during the study participation period (between 1-4 weeks).
Fractional PBUT excretion
This will be calculated for seven PBUTs (indoxyl sulfate, p-cresyl sulfate, indole-3-acetic acid, kynurenic acid, L-kynurenine, hippuric acid, p-cresyl glucuronide) before and after start of furosemide treatment using the following formula:
(Urine PBUT concentration * plasma creatinine concentration) / (urine creatinine concentration * plasma PBUT concentration)
Measured: This will be assessed three times during the study participation period (between 1-4 weeks).
PBUT protein binding
This will be determined for seven PBUTs (indoxyl sulfate, p-cresyl sulfate, indole-3-acetic acid, kynurenic acid, L-kynurenine, hippuric acid, p-cresyl glucuronide) before and after start of furosemide treatment by determining the total PBUT plasma concentration and the free fraction of the PBUTs.
Measured: This will be assessed three times during the study participation period (between 1-4 weeks).
Ratio of the surrogate PBUT clearance / CKD-EPI creatinine equation
This will be calculated for seven PBUTs (indoxyl sulfate, p-cresyl sulfate, indole-3-acetic acid, kynurenic acid, L-kynurenine, hippuric acid, p-cresyl glucuronide) before and after start of furosemide treatment using the following formulas:
For surrogate of PBUT concentration:
Urine PBUT concentration / (urine creatinine concentration * plasma PBUT concentration)
For CKD-EPI creatinine equation: eGFR (in mL/min/1.73m^2) = 142* Min(Scr/K, 1)^α * Max(Scr/K, 1)^-1.200 * 0.9938^Age (in years) * 1.012 [if female]
In which:
eGFR = estimated glomerular filtration rate Scr = serum creatinine in mg/dL K = 0.7 for females, 0.9 for males α = -0.241 for females, -0.302 for males Min(Scr/K, 1) = the minimum of Scr/K or 1 Max(Scr/K, 1) = the maximum of Scr/K or 1
Measured: This will be assessed three times during the study participation period (between 1-4 weeks).
Ratio of the surrogate PBUT clearance / CKD-EPI cystatin C equation
This will be calculated for seven PBUTs (indoxyl sulfate, p-cresyl sulfate, indole-3-acetic acid, kynurenic acid, L-kynurenine, hippuric acid, p-cresyl glucuronide) before and after start of furosemide treatment using the following formulas:
For surrogate of PBUT concentration:
Urine PBUT concentration / (urine creatinine concentration * plasma PBUT concentration)
For CKD-EPI cystatin C equation: eGFR (in mL/min/1.73m^2) = 133 * Min(Scys/0.8, 1)^-0.499 * Max(Scys/0.8, 1)^-1.328 * 0.996^Age (in years) * 0.932 [if female]
In which:
eGFR = estimated glomerular filtration rate Scys = serum cystatin C in mg/L Min(Scys/0.8, 1) = the minimum of Scys/0.8 or 1 Max(Scys/0.8, 1) = the maximum of Scys/0.8 or 1
Measured: This will be assessed three times during the study participation period (between 1-4 weeks).
Ratio of the surrogate PBUT clearance / CKD-EPI creatinine-cystatin C equation
This will be calculated for seven PBUTs (indoxyl sulfate, p-cresyl sulfate, indole-3-acetic acid, kynurenic acid, L-kynurenine, hippuric acid, p-cresyl glucuronide) before and after start of furosemide treatment using the following formulas:
For surrogate of PBUT concentration:
Urine PBUT concentration / (urine creatinine concentration * plasma PBUT concentration)
For CKD-EPI cystatin C equation: eGFR (in mL/min/1.73m^2) = 135 * Min(Scr/K, 1)^α * Max(Scr/K, 1)^-0.544 * Min(Scys/0.8, 1)^-0.323 * Max(Scys/0.8, 1)^-0.778 * 0.9961^Age (in years) * 0.963 [if female]
In which:
eGFR = estimated glomerular filtration rate Scr = serum creatinine in mg/dL Scys = serum cystatin C in mg/L K = 0.7 for females, 0.9 for males α = -0.219 for females, -0.144 for males Min(Scr/K, 1) = the minimum of Scr/K or 1 Min(Scys/0.8, 1) = the minimum of Scys/0.8 or 1 Max(Scr/K, 1) = the maximum of Scr/K or 1 Max(Scys/0.8, 1) = the maximum of Scys/0.8 or 1
Measured: This will be assessed three times during the study participation period (between 1-4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start10 Jun 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
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 Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, MERLN Institute for Technology-Inspired Regenerative Medicine, Utrecht Institute for Pharmaceutical Sciences
- Responsible party
- Principal investigator, Karin G.F. Gerritsen, UMC Utrecht
- Investigators
- Karin GF Gerritsen, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750575
- Sponsor's protocol ID
- NL81338.041.23
- Other IDs
- 23-239/G
- Acronym
- FUROPBUT
- Status last verified
- Dec 2024
- First submitted
- 17 Oct 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data package will contain: the raw data, the study protocol describing the methods and materials, the script to process the data, the scripts leading to tables and figures in the publication, a codebook with explanations on the variable names, and a 'read\_me.txt' file with an overview of files included and their content and use. All data and documents in the data package will be shared under restrictions. The publication will be openly assessable. The study protocol and this Data Management Plan will also be available.
Publications
Mihaila SM, Faria J, Stefens MFJ, Stamatialis D, Verhaar MC, Gerritsen KGF, Masereeuw R. Drugs Commonly Applied to Kidney Patients May Compromise Renal Tubular Uremic Toxins Excretion. Toxins (Basel). 2020 Jun 12;12(6):391. doi: 10.3390/toxins12060391.
PubMed 32545617
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Furosemide on Protein-Bound Uremic Toxin Plasma Levels and Excretion in Patients with Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06750575
- Acronym / sponsor ID
- FUROPBUT / NL81338.041.23
- Conditions
- Chronic Kidney Diseases, Renal Failure Chronic
- Keywords
- Furosemide, Drug-toxin interactions, Protein-bound uremic toxins, P-cresyl sulfate, Indoxyl sulfate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Maastricht University, MERLN Institute for Technology-Inspired Regenerative Medicine, Utrecht Institute for Pharmaceutical Sciences
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 27 Dec 2024 (actual)
- 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 goal of this observational study is to examine the interaction between the diuretic furosemide and certain toxins called protein-bound uremic toxins (PBUTs) in patients with chronic kidney disease (CKD). The main question it aims to answer is: what is the effect of furosemide on plasma levels of PBUTs in patients with CKD? Besides, the investigators will also look at the effect of furosemide on the excretion of PBUTs via the urine.
Participants will be included in the study once they will be prescribed furosemide as part of routine patient care. Before they start with the furosemide treatment, patients will undergo the following:
- Blood pressure measurement
- Blood sample withdrawal
- Urine sample collection
- 12-hour urine collection
Then, one to four weeks after starting with furosemide treatment, patients will undergo the following:
- Blood pressure measurement
- Blood sample prior to furosemide intake (Tmin)
- Blood sample withdrawal 90 minutes after furosemide intake (Tmax: time at which the highest furosemide plasma level is expected)
- Urine sample collection 60-120 minutes after furosemide intake
- 12-hour urine collection
The investigators expect furosemide to increase plasma levels of PBUTs by decreasing the renal excretion of the toxins.
Detailed description
Protein-bound uremic toxins are known to accumulate in chronic kidney disease (CKD) and are associated with increased morbidity and mortality. It is therefore crucial to maintain the PBUT levels low in this patient group. Furosemide is often prescribed to CKD patients. However, based on preclinical data, furosemide could affect the renal excretion of PBUTs, either by competing for binding to albumin or by competing for the secretory system in the kidney. It is important to examine the effect of furosemide on the excretion and plasma concentration PBUTs as this might have harmful consequences for patients with CKD.
This study aims to examine the effect of furosemide PBUT plasma levels in patients with CKD as well as the renal PBUT excretion. The investigators expect furosemide to increase plasma levels of PBUTs by decreasing the renal excretion of the toxins.
This study is observational and includes invasive measurements; a prospective repeated measures cohort study design will be used in which PBUT plasma concentrations and excretion will be determined before and after the start of furosemide treatment.
The study population consists of patients with CKD stage 3-5 (<60 mL/min/1.73m2 for at least three months) who have an indication for furosemide treatment as part of routine patient care. Participants will receive furosemide in a dosage prescribed by their nephrologist as part of their routine patient care; this treatment is not changed by the participation of patients in the study.
A power analysis for a paired samples T-Test was done using GPower (version 3.1.9.4). Data regarding PBUT plasma levels from the study of Tang et al. in 2021 was used in order to calculate the sample size; PCS plasma levels before (average ± standard deviation: 13,481 ± 12,642 nM) and after (average ± standard deviation: 23,000 ± 24,900 nM) furosemide intake were chosen, since PCS is one of the main PBUTs of interest. This calculation showed a required sample size of 34 (one-tail, power = 80%, α = 0.05, d = 0.44, correlation between samples 0.5 based on assumption).
Prior to the start of the furosemide treatment, a blood sample (three tubes/11 mL per withdrawal) and a urine sample will be collected from patients enrolled in the study. Participants will also hand in a 12-hour urine collection and their blood pressure will be measured.
After the start of the furosemide treatment (at least one week after the start of the furosemide treatment so that steady state has been reached), two blood samples, one urine sample, and a 24-hour urine collection will be obtained. Participants will be asked to obtain a 12-hour urine collection and to bring this with them on the day the of the visit. During the visit at the University Medical Center Utrecht, participants will first hand in the 12-hour urine collection and their blood pressure will be measured. Furthermore, a blood sample will be taken prior to the furosemide intake (Tmin). Then, they will take their prescribed furosemide at around the same time as they normally take their medication. 60 minutes after the furosemide intake, participants will be asked to empty their bladder and drink two glasses of water. Then, at Tmax, a blood sample will be collected. Tmax is estimated at around 90 minutes after oral intake; therefore, the target time of sample collection is 90 min with an acceptable range between 60-120 minutes after furosemide intake. Furthermore, a urine sample will be collected between 60 and 120 minutes after furosemide intake in order to best examine the effect of furosemide on PBUT excretion. The exact time of furosemide intake and the time of the blood and urine sample collection will be registered.
The main endpoints of this study are PBUT plasma levels before and 1-4 weeks after the start of furosemide treatment (in a steady state).
Baseline characteristics and study parameters will be presented as either a mean with standard deviation or a median with interquartile range for continuous data, or as a percentage for categorical data. Results with a p<0.05 will be considered statistically significant. Analyses will be done using the statistical software platforms SPSS and R. Missing data will be excluded from the analyses via pairwise deletion.
Participants will only receive furosemide prescribed by their treating nephrologist as part of routine patient care. In addition, three blood sample drawings, two urine samples, and two 12-hour urine collections will be needed. Thus, the risk associated with participation is negligibly low. Participation to the study will include two site visits. These visits will be combined with routine check-ups as much as possible.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease stage 3-5 | – | Diagnostic Test: Invasive measurementsParticipants with an age of 18 years or older and with CKD stage 3-5 (an estimated glomerular filtration rate of 60 mL/min/1.73m^2 or lower for at least three months). Participants need to have an indication to start with furosemide as part of routine patient care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) of 18 years and older with an indication for starting treatment with furosemide as part of routine patient care. Participants will be recruited at the Department of Nephrology in the University Medical Center Utrecht (UMCU, Utrecht, The Netherlands) who have not yet started furosemide treatment or any renal replacement therapy.
Key inclusion criteria (4 listed)
- An age of 18 years or older
- An eGFR <60 mL/min/1.73m2 for at least three months (diagnosis of CKD stage 3-5)
- An indication for the start of treatment with furosemide as part of routine patient care
- Willingness to participate in the study and a signed informed consent
Key exclusion criteria (6 listed)
- Patients who are already on furosemide treatment
- Patients with a liver disease with hyperbilirubinemia
- Patients who receive any type of renal replacement therapy (peritoneal dialysis, haemodialysis)
- Patients with end-stage renal failure without residual diuresis
- Patients who will start with medication simultaneously with start of furosemide treatment that might interfere with PBUT excretion or PBUT protein binding
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 |
|---|---|---|
| Invasive measurementsBlood and urine samples will be collected during the study. | Diagnostic test | Chronic kidney disease stage 3-5 |
Primary outcome
Plasma levels of the PBUT indoxyl sulfate
Time frame: This will be assessed three times during the study participation period (between 1-4 weeks).
Indoxyl sulfate plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Plasma levels of the PBUT p-cresyl sulfate
Time frame: This will be assessed three time during the study participation period (between 1-4 weeks).
P-cresyl sulfate plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Plasma levels of the PBUT indole-3-acetic acid
Time frame: This will be assessed three times during the study participation period (between 1-4 weeks).
Indole-3-acetic acid plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Plasma levels of the PBUT kynurenic acid
Time frame: This will be assessed three times during the study participation period (between 1-4 weeks).
Kynurenic acid plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Plasma levels of the PBUT L-kynurenine
Time frame: This will be assessed three times during the study participation period (between 1-4 weeks).
L-kynurenine plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Plasma levels of the PBUT hippuric acid
Time frame: This will be assessed three times during the study participation period (between 1-4 weeks).
Hippuric acid plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
Plasma levels of the PBUT p-cresyl glucuronide
Time frame: This will be assessed three times during the study participation period (between 1-4 weeks).
P-cresyl glucuronide plasma levels (in ng/mL) will be determined before and after start of furosemide treatment.
6 secondary outcomes
Surrogate for PBUT clearance
Time frame: This will be assessed three times during the study participation period (between 1-4 weeks).
Fractional PBUT excretion
Time frame: This will be assessed three times during the study participation period (between 1-4 weeks).
PBUT protein binding
Time frame: This will be assessed three times during the study participation period (between 1-4 weeks).
Ratio of the surrogate PBUT clearance / CKD-EPI creatinine equation
Time frame: This will be assessed three times during the study participation period (between 1-4 weeks).
Ratio of the surrogate PBUT clearance / CKD-EPI cystatin C equation
Time frame: This will be assessed three times during the study participation period (between 1-4 weeks).
Ratio of the surrogate PBUT clearance / CKD-EPI creatinine-cystatin C equation
Time frame: This will be assessed three times during the study participation period (between 1-4 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 32545617Mihaila SM, Faria J, Stefens MFJ, Stamatialis D, Verhaar MC, Gerritsen KGF, Masereeuw R. Drugs Commonly Applied to Kidney Patients May Compromise Renal Tubular Uremic Toxins Excretion. Toxins (Basel). 2020 Jun 12;12(6):391. doi: 10.3390/toxins12060391.
- Individual participant dataSharing planned: Yes. The data package will contain: the raw data, the study protocol describing the methods and materials, the script to process the data, the scripts leading to tables and figures in the publication, a codebook with explanations on the variable names, and a 'read_me.txt' file with an overview of files included and their content and use. All data and documents in the data package will be shared under restrictions. The publication will be openly assessable. The study protocol and this Data Management Plan will also be available.
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Karin GF Gerritsen, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Renal Failure Chronic, run by UMC Utrecht at 1 site in Netherlands.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. 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 Netherlands. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dian P Bolhuis, MD, MSc (+31-887557375, d.p.bolhuis-3@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of the PBUT indoxyl sulfate (time frame: This will be assessed three times during the study participation period (between 1-4 weeks).). The study lists 7 primary outcomes in all. 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 NCT06750575, 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 27 Dec 2024.