CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Chlorthalidone +1 moredrug
Likely dose
Not stated in 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/NCT03923933
NCT03923933Phase 2Completed

Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial

Hospital General de México Dr. Eduardo Liceaga·interventional·Posted Apr 23, 2019·Updated Nov 23, 2020

In Brief

A Phase 2 clinical trial evaluating Chlorthalidone and Bumetanide for Renal Insufficiency, Chronic. Completed, enrolled 34 participants across 1 site.

Detailed Summary

This study aims to demonstrate the possible benefit of a treatment based on double diuretic in patients with chronic kidney disease and severely impaired glomerular filtration rate. This is based on previous observations where the investigators found that volume overload is a frequent condition within this population and is strongly linked to an increase in morbidity and mortality. The investigators consider that this therapy could be beneficial given that most of these patients are treated with loop diuretics, however, with the passage of time, adaptive changes in the distal nephron occur that promote a decrease in the treatment effect. In this sense, thiazide diuretics at appropriate doses could 'break' the resistance, since their mechanism of action antagonizes the resistance mechanism. Unfortunately, to this day, this treatment has not been fully evaluated. Particularly in this type of population. The investigators developed a study proposed as a double blind randomized clinical trial, where the population will be divided into two groups. A group will be given the standard treatment based on loop diuretic (bumetanide), while the other group will receive the intervention (bumetanide plus chlorthalidone). After a 30-day follow-up period, the results will be measured. With respect to the effectiveness of the treatment, the decrease in volume overload by bioimpedance will be measured. While the occurrence of adverse effects during the same monitoring period will be observed.

Study Details

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

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 23, 2019
Enrollment StartJun 18, 2019
Primary CompletionOct 28, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.2 years ago

Interventions

Chlorthalidonedrug

Chlorthalidone

Bumetanidedrug

Bumetanide