CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
Furosemide Injection +2 moredrug
Likely dose
Furosemide Injection 1mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05105009
NCT05105009Phase 1Completed

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

Instituto Nacional de Cardiologia Ignacio Chavez·interventional·Posted Nov 3, 2021·Updated Dec 17, 2024

In Brief

A Phase 1 clinical trial evaluating Furosemide Injection, Creatinine Powder, and 1 other intervention for Chronic Kidney Failure. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedNov 3, 2021
Enrollment StartMar 3, 2020
Primary CompletionOct 21, 2023
Study CompletionAug 27, 2024
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 4.7 years ago

Interventions

Furosemide Injectiondrug

* 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

Creatinine Powderdrug

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

Iohexoldrug

5 ml iohexol (Omnipaque) intravenously