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

NCT05105009 | Completed Phase 1 DMC

• 1 other identifier: 19-1131
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Failure

Outcome Measures

Primary Outcomes (1)

• Tubular Residual Kidney Function

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

  1 year

Study Arms (1)

All KDIGO stages and healthy volunteers

EXPERIMENTAL

15 healthy volunteers and 35 through all KDIGO stages.

Drug: Furosemide Injection; Drug: Creatinine Powder; Drug: Iohexol

Interventions

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

Also known as: Furosemide

All KDIGO stages and healthy volunteers

Creatinine Powder DRUG

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

Also known as: Creatinine

All KDIGO stages and healthy volunteers

Iohexol DRUG

5 ml iohexol (Omnipaque) intravenously

All KDIGO stages and healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional de Cardiologia Ignacio Chávez

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (28)

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  PMID: 40126554 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Furosemide; Creatinine; Iohexol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nephrology

Model Details: all KDIGO stages and healthy volunteers (Kidney donors)

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: November 3, 2021
• Study Start: March 3, 2020
• Primary Completion: October 21, 2023
• Study Completion: August 27, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)