A Phase 1 interventional study of Furosemide Injection and Creatinine Powder in Chronic Kidney Failure, sponsored by Instituto Nacional de Cardiologia Ignacio Chavez. Completed at 1 site in Mexico. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Instituto Nacional de Cardiologia Ignacio Chavez · Phase 1, Interventional, and Diagnostic
This is a two phase study. The first part will take place at the National Institute of Cardiology in Mexico, the second phase will be made in collaboration with the University of California San Diego and University of Minnesota.
This is a non blind experimental study, 72 patients with different stages of CKD from the outpatient unit of the institute will be included. Each patient will receive a furosemide stress test of 1 mg/kg in non diuretic users and 1.5 mg/kg in diuretic users, in addition of 5 grams of creatinine oral intake, as well as Iohexol 5ml IV to measure GFR. After the intervention, blood and urine samples will be drawn at baseline, 60 minutes, 180 minutes, and 240 min. Urine output will be maintained during the study by the intravenous administration of Hartman's solution 1 -2 ml/kg body weight every hour, in addition to the volume of urine output in the preceding hour plus oral water ingestion as tolerated.
Blood and urine will be analized to measure creatinine (blood and urine), then samples will be processed for measurement of furosemide (HPLC-Uv vis), indoxyl sulphate, p-cresol, hippurate, and iohexol (mass spectometry).
The aim of this stiudy is to asses the differences between GFR and proximal tubule function.
Residual kidney function (RKF) its a critical tool in the CKD evolution and prognosis. It's well known that preserving RKF increases survival in patients with CKD.
Traditionally Glomerular Filtration Rate (GFR), and proteinuria have been the variables used to asses RKF, wich are glomerular residual function (GRF) variables. This glomerulocentric assestment of RKF has been challenged recently. It is knows that urea is not the principal uremic toxine, the protein boud uremic toxins are particullary important because it's elimination depends of the proximal tubular organic anionic transporters (OAT), and the organic cationic transporters (OCT). The functional integrity of this transporters are lost in advanced CKD stages, and it´s accumulation increases cardiovascular and renal damage because they activate proinflammatory citokines, increasing mortality, this was shown specially with the accumulation and clearance of hippurate and p-cresol independently of GFR.
The purpose of this study is to asses the functional capacity of two AOT (hOAT1, and hOAT3, that can be blocked by furosemide), and one OCT (OCT2 blocked by creatinine) using an stress test. The stress test will be performed in healthy subjects as well as in CKD from different stages. Protein bound uremic toxins such as indoxyl sulphate, p-cresol, and hippurate will be measured.
In the stress the typical furosemide stress test described previously by Mehta will be implemented, in addition to an oral load of 5 grams of creatinine oral load. This levels should be efficient enough to assess the functionality of the OCT2. A comparison between the tubular creatinine secretine to filtrated creatinine measuring GFR using Iohexol will be performed.
In conclusion this is a pilot study aimed to establish a practical methodology for the assesment of proximal tubular function.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 50 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Instituto Nacional de Cardiologia Ignacio Chavez is the lead sponsor of 45 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
15 healthy volunteers and 35 through all KDIGO stages.
Drug: Furosemide Injection · Drug: Creatinine Powder · Drug: Iohexol
* Furosemide Stress Test ( 1mg/kg in non diuretic users and 1.5 mg/kg in diuretic users). * Oral creatinine load using 5 grams of creatinine
Also known as: Furosemide
5g of creatinine (Sigma) in 250 ml of water was taken orally
Also known as: Creatinine
5 ml iohexol (Omnipaque) intravenously
Tubular Residual Kidney Function
To assess the functionallity of the hOAT1 and 3, and hOCT2 by stress test using furosemide and creatinine loads.
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Cardiologia Ignacio Chavez