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NCT Number: NCT05105009

Furosemide and Creatinine Tubular Stress Test in Order to Measure Proximal Tubule Residual Function

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.

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Key information

Conditions

Chronic Kidney Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Instituto Nacional de Cardiologia Ignacio Chávez

Mexico City, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18 years old.
  • Patients with CKD that attends to the outpatient clinic.
  • Residual uresis of 500 mL

Exclusion criteria

  • Patients younger than 18 years old.
  • Increase of Cr in a rate of 0.5 mg/dL, or loss of more than 30% of previous GFR.
  • Patients with cardiorrenal syndrome type 1.
  • Patients with dilated miocardiopathy.
  • Volume overload or incomplete voiding

Treatment and study plan

Furosemide Injection

Drug
  • 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

Other names: Furosemide

Creatinine Powder

Drug

5g of creatinine (Sigma) in 250 ml of water was taken orally

Other names: Creatinine

Iohexol

Drug

5 ml iohexol (Omnipaque) intravenously

Primary outcomes

  1. Tubular Residual Kidney Function

    Time frame: 1 year

    To assess the functionallity of the hOAT1 and 3, and hOCT2 by stress test using furosemide and creatinine loads.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Other

Registry information

Official study title

Furosemide and Creatinine Tubular Stress Test in Order to Measure Proximal Tubule Residual Function: is It Better Than GFR?

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Nov 3, 2021
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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