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Furosemide Stress Test as a Predictor of Tubular Function in Chronic Kidney Disease

Information source: Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease

Intervention: Furosemide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Instituto Nacional de Cardiologia Ignacio Chavez

Official(s) and/or principal investigator(s):
Magdalena Madero, MD, Principal Investigator, Affiliation: Chief of the Nephrology Department

Overall contact:
Magdalena Madero, MD, Phone: +55-5573-2911, Ext: 1262, Email: madero.magdalena@gmail.com

Summary

In kidney diseases, tubule-interstitium has become much more relevant, as formerly only the glomerulus was considered to have the main importance. Kidney's tubular atrophy and interstitital fibrosis is now recognized as long term prognostic value. We aim to evaluate the function of the kidney's tubule-interstitium through furosemide excretion after intravenous administration of this drug, and correlate the rate of excretion of furosemide with interstitial fibrosis findings in scheduled kidney biopsy for patients with chronic kidney disease.

Clinical Details

Official title: Furosemide Stress Test as a Predictor of Tubular Atrophy and Interstitial Fibrosis in Patients With Chronic Kidney Disease

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: Urinary Output

Secondary outcome:

Furosemide excretion rate

Interstitial Fibrosis

Detailed description: All patients scheduled for kidney biopsy will be invited to participate in a standard isovolemic furosemide stress test before the biopsy procedure. The latter will consist in 1. 5 miligrams per kilogram of weight of intravenous furosemide administration, with urinary output follow up and measurement. The urinary output will be replaced intravenously with normal saline to avoid dehydration and/or hypotension. A standard 5ml sample of blood will be taken before the test and aliquots of urine before and after furosemide administration will be frozen. After completion of the formely mentioned test, patients will proceed to their scheduled kidney biopsy along with interventions considered appropiate by their attending physician. Kidney biopsy sample will be examined by histopathology service and the degree of interstitial fibrosis will be described. The degree of fibrosis will be correlated with the degree furosemide excretion and urinary output.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Accept to participate (informed consent)

- Legal age or older

- An estimated glomerular filtration rate greater than 15ml/min/1. 73m2, calculated by

CKD-EPI. Exclusion Criteria:

- Known Alergic reaction to furosemide

- Contraindication to kidney biopsy

- Patient already in renal replacement therapy

Locations and Contacts

Magdalena Madero, MD, Phone: +55-5573-2911, Ext: 1262, Email: madero.magdalena@gmail.com

Instituto Nacional de Cardiologia Ignacio Chavez, Mexico city, DF 14080, Mexico; Recruiting
Magdalena Madero, MD, Email: madero.magdalena@gmail.com
Additional Information

Related publications:

Boor P, Ostendorf T, Floege J. Renal fibrosis: novel insights into mechanisms and therapeutic targets. Nat Rev Nephrol. 2010 Nov;6(11):643-56. doi: 10.1038/nrneph.2010.120. Epub 2010 Sep 14. Review.

Burns WC, Kantharidis P, Thomas MC. The role of tubular epithelial-mesenchymal transition in progressive kidney disease. Cells Tissues Organs. 2007;185(1-3):222-31. Review.

Farris AB, Chan S, Climenhaga J, Adam B, Bellamy CO, SerĂ³n D, Colvin RB, Reeve J, Mengel M. Banff fibrosis study: multicenter visual assessment and computerized analysis of interstitial fibrosis in kidney biopsies. Am J Transplant. 2014 Apr;14(4):897-907. doi: 10.1111/ajt.12641. Epub 2014 Feb 20.

Farris AB, Colvin RB. Renal interstitial fibrosis: mechanisms and evaluation. Curr Opin Nephrol Hypertens. 2012 May;21(3):289-300. doi: 10.1097/MNH.0b013e3283521cfa. Review.

van der Voort PH, Boerma EC, Pickkers P. The furosemide stress test to predict renal function after continuous renal replacement therapy. Crit Care. 2014 May 14;18(3):429. doi: 10.1186/cc13871.

Starting date: April 2015
Last updated: April 13, 2015

Page last updated: August 23, 2015

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