AzTrials
AzTrials

Renal Insufficiency, ChronicPhase 2NCT03923933

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

A Phase 2 study testing Chlorthalidone and Bumetanide in people with Renal Insufficiency, Chronic, run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Insufficiency, Chronic
What is being tested?
Chlorthalidone and Bumetanide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteMexico
Study dates
18 Jun 2019to 28 Oct 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • glomerular filtration rate less than 30 ml / min / 1.73m
  • Without replacement therapy (dialysis or hemodialysis)
  • Volume overload
  • At least 100 ml per day of residual diuresis
  • Use of a loop diuretic for at least one month

Who cannot join

  • Allergies known to diuretics
  • Patients with severe infections
  • Patients with hemodynamic instability
  • Amputees
  • Patients with cognitive impairment
  • Patients with acute renal failure
  • Patients with graft loss

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital General de Mexico

    Mexico City, 06720

Other trials in Mexico

About this study

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.

Being tested
Chlorthalidone, Bumetanide
Keywords
Diuretics, Bumetanide, Chlorthalidone, Chronic Kidney Disease, Volume Overload
Medical subject headings
Renal Insufficiency, Chronic, Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChlorthalidoneDrug

    Chlorthalidone

  • BumetanideDrug

    Bumetanide

Study groups in NCT03923933
Study groupRoleWhat they receive
PlaceboPlacebo comparatorThis group will receive 3 milligrams of bumetanide per day for a week plus placebo (starch) that will simulate the chlorthalidone dose of the treatment group. In case the dose is well tolerated, the dose of bumetanide will be increased to 4 milligrams per day.
Receives: Drug: Bumetanide
Treatment grupExperimentalThis group will receive 3 milligrams of bumetanide plus 50 milligrams of chlorthalidone per day, for a week. If the dose is well tolerated, it will be increased to 4 milligrams of bumetanide and 100 milligrams of chlorthalidone per day.
Receives: Drug: Chlorthalidone; Drug: Bumetanide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Total Body Water

    Measured by bioelectrical impedance analysis, compared to the initial measurement

    Measured: Change from Basal to day 28

Secondary outcomes (6)

  1. Change in Mean Arterial Pressure

    decrease in blood pressure compared wit baseline measure (mmhg)

    Measured: Change from Basal to day 28

  2. Change in the Fractional Excretion of Sodium

    Increase in the fractional excretion of sodium compared with the baseline measure

    Measured: Change from Basal to day 28

  3. Change in Extracellular Water

    Decrease in extracellular water measured by bioelectrical impedance analysis

    Measured: Change from Basal to day 28

  4. Change in Extracellular Water / Total Body Water Ratio

    Decrease in extracellular water / total body water ratio measured by bioelectrical impedance analysis

    Measured: Change from Basal to day 28

  5. Change in Systolic Blood Pressure

    Measured: Change from Basal to day 28

  6. Change in Diastolic Blood Pressure

    Measured: Change from Basal to day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2019
  2. Study start18 Jun 2019
  3. Primary completion28 Oct 2019
  4. Study completion28 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03923933
Sponsor's protocol ID
DI/19/105-B/03/018
Status last verified
Nov 2020
First submitted
18 Apr 2019
Last updated
23 Nov 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bello AK, Levin A, Tonelli M, Okpechi IG, Feehally J, Harris D, Jindal K, Salako BL, Rateb A, Osman MA, Qarni B, Saad S, Lunney M, Wiebe N, Ye F, Johnson DW. Assessment of Global Kidney Health Care Status. JAMA. 2017 May 9;317(18):1864-1881. doi: 10.1001/jama.2017.4046.

    PubMed 28430830

  • Neuen BL, Chadban SJ, Demaio AR, Johnson DW, Perkovic V. Chronic kidney disease and the global NCDs agenda. BMJ Glob Health. 2017 Jul 6;2(2):e000380. doi: 10.1136/bmjgh-2017-000380. eCollection 2017. No abstract available.

    PubMed 29225940

  • Levey AS, Coresh J. Chronic kidney disease. Lancet. 2012 Jan 14;379(9811):165-80. doi: 10.1016/S0140-6736(11)60178-5. Epub 2011 Aug 15.

    PubMed 21840587

  • van de Luijtgaarden MW, Noordzij M, van Biesen W, Couchoud C, Cancarini G, Bos WJ, Dekker FW, Gorriz JL, Iatrou C, Wanner C, Finne P, Stojceva-Taneva O, Cala S, Stel VS, Tomson C, Jager KJ. Conservative care in Europe--nephrologists' experience with the decision not to start renal replacement therapy. Nephrol Dial Transplant. 2013 Oct;28(10):2604-12. doi: 10.1093/ndt/gft287. Epub 2013 Sep 7.

    PubMed 24013682

  • Morton RL, Turner RM, Howard K, Snelling P, Webster AC. Patients who plan for conservative care rather than dialysis: a national observational study in Australia. Am J Kidney Dis. 2012 Mar;59(3):419-27. doi: 10.1053/j.ajkd.2011.08.024. Epub 2011 Oct 20.

    PubMed 22014401

  • Wong SPY, Hebert PL, Laundry RJ, Hammond KW, Liu CF, Burrows NR, O'Hare AM. Decisions about Renal Replacement Therapy in Patients with Advanced Kidney Disease in the US Department of Veterans Affairs, 2000-2011. Clin J Am Soc Nephrol. 2016 Oct 7;11(10):1825-1833. doi: 10.2215/CJN.03760416. Epub 2016 Sep 22.

    PubMed 27660306

  • Davison SN, Levin A, Moss AH, Jha V, Brown EA, Brennan F, Murtagh FE, Naicker S, Germain MJ, O'Donoghue DJ, Morton RL, Obrador GT; Kidney Disease: Improving Global Outcomes. Executive summary of the KDIGO Controversies Conference on Supportive Care in Chronic Kidney Disease: developing a roadmap to improving quality care. Kidney Int. 2015 Sep;88(3):447-59. doi: 10.1038/ki.2015.110. Epub 2015 Apr 29.

    PubMed 25923985

  • Verberne WR, Dijkers J, Kelder JC, Geers ABM, Jellema WT, Vincent HH, van Delden JJM, Bos WJW. Value-based evaluation of dialysis versus conservative care in older patients with advanced chronic kidney disease: a cohort study. BMC Nephrol. 2018 Aug 16;19(1):205. doi: 10.1186/s12882-018-1004-4.

    PubMed 30115028

  • Murtagh FE, Addington-Hall JM, Edmonds PM, Donohoe P, Carey I, Jenkins K, Higginson IJ. Symptoms in advanced renal disease: a cross-sectional survey of symptom prevalence in stage 5 chronic kidney disease managed without dialysis. J Palliat Med. 2007 Dec;10(6):1266-76. doi: 10.1089/jpm.2007.0017.

    PubMed 18095805

  • Thomas R, Kanso A, Sedor JR. Chronic kidney disease and its complications. Prim Care. 2008 Jun;35(2):329-44, vii. doi: 10.1016/j.pop.2008.01.008.

    PubMed 18486718

  • Hung SC, Lai YS, Kuo KL, Tarng DC. Volume overload and adverse outcomes in chronic kidney disease: clinical observational and animal studies. J Am Heart Assoc. 2015 May 5;4(5):e001918. doi: 10.1161/JAHA.115.001918.

    PubMed 25944876

  • Titze J. Interstitial fluid homeostasis and pressure: news from the black box. Kidney Int. 2013 Nov;84(5):869-71. doi: 10.1038/ki.2013.287.

    PubMed 24172732

  • Yatime L, Laursen M, Morth JP, Esmann M, Nissen P, Fedosova NU. Structural insights into the high affinity binding of cardiotonic steroids to the Na+,K+-ATPase. J Struct Biol. 2011 May;174(2):296-306. doi: 10.1016/j.jsb.2010.12.004. Epub 2010 Dec 21.

    PubMed 21182963

  • Khalaf FK, Dube P, Mohamed A, Tian J, Malhotra D, Haller ST, Kennedy DJ. Cardiotonic Steroids and the Sodium Trade Balance: New Insights into Trade-Off Mechanisms Mediated by the Na(+)/K(+)-ATPase. Int J Mol Sci. 2018 Aug 30;19(9):2576. doi: 10.3390/ijms19092576.

    PubMed 30200235

  • Akchurin OM, Kaskel F. Update on inflammation in chronic kidney disease. Blood Purif. 2015;39(1-3):84-92. doi: 10.1159/000368940. Epub 2015 Jan 20.

    PubMed 25662331

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chlorthalidone and Bumetanide in people with Renal Insufficiency, Chronic, run by Hospital General de México Dr. Eduardo Liceaga at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Total Body Water (time frame: Change from Basal to day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03923933, which also lists 50 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in