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Metabolic AcidosisPhase 4AlcalUNNCT03035812

Alkalinization by Urologists & Nephrologists

A Phase 4 study testing Alkali in people with Metabolic Acidosis and Nephrolithiasis, run by Jean-Philippe Bertocchio at 18 sites in France.

Completed

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

Official record
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Trial summary

Metabolic acidosis recovers a wide range of diseases in which an oral alkalinization could be useful. This therapeutic intervention has been said to increase extracellular volume leading to rising blood pressure. No prospective data has been published in clinical routine. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Alkali
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
18 sitesFrance
Study dates
1 Feb 2017to 21 Feb 2020
Phase
Phase 4
Are there results?
None posted in the registry

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

  • > or = to 18 years old
  • in whom an oral alkalinization is indicated

Who cannot join

  • if the patient mentions its opposition to his/her enrollment

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • Centre Hospitalier Pierre Oudot - Bourgoin-Jallieu

    Bourgoin, 38300

  • La Cavale Blanche Hospital

    Brest, 29600

  • CHMS Chambery

    Chambéry

  • University Hospital of Grenoble

    Grenoble

  • Calydial

    Irigny

  • E.C.H.O. (Expansion des Centres d'Hémodialyse de l'Ouest)

    Le Mans, 72016

  • La Conception University Hospital, AP-HM

    Marseille, 13005

  • Institut Phocéen de Néphrologie, Clinique Bouchard

    Marseille

  • Uninversity Hospital of Nantes

    Nantes

  • AURA Paris Plaisance

    Paris, 75014

  • European Georges Pompidou Hospital

    Paris, 75908

  • Tenon Hospital, AP-HP

    Paris

  • Maison Blanche Hospital

    Reims

  • Rennes Hospital

    Rennes

  • Aub Sante

    St-Malo, 35400

  • Clinic area

    Strasbourg

  • Clinique Sainte Anne

    Strasbourg

  • HIA Sainte-Anne

    Toulon, 83000

Other trials in France

About this study

Official title: Prospective Evaluation of Oral Alkalinization by Urologists and Nephrologists: Evolution of the Extracellular Compartment

Metabolic acidosis recovers a wide range of diseases in which an oral alkalinization could be useful. This therapeutic intervention has been said to increase extracellular volume leading to rising blood pressure. No prospective data has been published in clinical routine. Here, investigators propose to follow patients in which an oral alkalinization is indicated: blood pressure, body weight, and a clinical evaluation of the extracellular compartment will be performed at the beginning and during the follow-up of participants. The principal criterion of evaluation will be the variation in the extracellular compartment.

Read the detailed description

Metabolic acidosis recovers a wide range of diseases - chronic kidney diseases, nephrolithiasis, or others - in which an oral alkalinization could be useful. Oral alkalinization could be performed or by bicarbonate contained in alkaline-based waters or drug therapies or by citrate. This therapeutic intervention has been said to increase extracellular volume leading to rising blood pressure, especially due to the amount of daily sodium load. No prospective data has been published in clinical routine, studying its effects on extracellular volume nor the blood pressure control.

Here, investigators propose to follow patients in which an oral alkalinization is indicated: blood pressure, body weight, and a clinical evaluation of the extracellular compartment will be performed at the beginning and during the follow-up of participants. Initial recorded data will be: age, gender, prescription (indication, kind of alkali therapy, volume and duration), body weight, body length, a clinical appreciation of the extracellular compartment, blood pressure, comorbidities, drug therapy, blood and urine composition. The recorded follow-up will be: the adherence to treatment, body weight, body length, a clinical appreciation of the extracellular compartment, blood pressure, adverse events, blood and urine composition.

The principal criterion of evaluation will be the variation in the extracellular compartment.

Being tested
Alkali
Keywords
Bicarbonate
Medical subject headings
Acidosis, Nephrolithiasis, Body Weight

What participants receive

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

  • AlkaliDrug

    Also called Bicarbonate, Citrate

    Oral intake of alkali therapy whatever the formulation (alkali-based water, powder or pharmaceutics)

Study groups in NCT03035812
Study groupRoleWhat they receive
AlkaliExperimentalPatients in whom an oral alkalinization whatever the formulation
Receives: Drug: Alkali

What is being measured

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

  1. Extracellular compartment M3

    Evaluation of the extracellular compartment by a composite clinical outcome at M3 composed by: body weight (kg), blood pressure (in mmHg, systolic and diastolic), and the presence edema

    Measured: At M3 (month 3)

Secondary outcomes (13)

  1. Natremia (mM)

    Evaluation of the impact of oral alkali therapy on natremia (mM)

    Measured: At M3 (month 3)

  2. Urine output (l/d)

    Evaluation of the impact of oral alkali therapy on urine output (l/d)

    Measured: At M3 (month 3)

  3. Extracellular compartment M6

    Evaluation of the extracellular compartment by a composite clinical outcome at M6 composed by: body weight (kg), blood pressure (in mmHg, systolic and diastolic), and the presence edema

    Measured: At M6 (month 6)

  4. Kalemia (mM)

    Evaluation of the impact of oral alkali therapy on kalemia (mM)

    Measured: At M3 (month 3)

  5. Blood chloride (mM)

    Evaluation of the impact of oral alkali therapy on blood chloride (mM)

    Measured: At M3 (month 3)

  6. Bicarbonatemia (mM)

    Evaluation of the impact of oral alkali therapy on bicarbonatemia (mM)

    Measured: At M3 (month 3)

  7. Proteinemia (g/l)

    Evaluation of the impact of oral alkali therapy on proteinemia (mM)

    Measured: At M3 (month 3)

  8. Albuminemia (g/l)

    Evaluation of the impact of oral alkali therapy on albuminemia (mM)

    Measured: At M3 (month 3)

  9. Creatininemia (microM)

    Evaluation of the impact of oral alkali therapy on creatininemia (mM)

    Measured: At M3 (month 3)

  10. Natriuresis (mmol/d)

    Evaluation of the impact of oral alkali therapy on natriuresis (mmol/d)

    Measured: At M3 (month 3)

  11. Urine chloride (mmol/d)

    Evaluation of the impact of oral alkali therapy on urine chloride (mmol/d)

    Measured: At M3 (month 3)

  12. Proteinuria (g/d)

    Evaluation of the impact of oral alkali therapy on proteinuria (g/d)

    Measured: At M3 (month 3)

  13. Creatinuria (mmol/d)

    Evaluation of the impact of oral alkali therapy on creatinuria (mmol/d)

    Measured: At M3 (month 3)

Timeline

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

  1. First posted30 Jan 2017 (estimated)
  2. Study start1 Feb 2017
  3. Primary completion21 Feb 2020
  4. Study completion21 Feb 2020

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Clinical and biological evaluation before and after an oral alkalinization
Masking
None (open label)
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03035812
Sponsor's protocol ID
AlcalUN
Acronym
AlcalUN
Status last verified
Jul 2020
First submitted
26 Jan 2017
Last updated
14 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Beaume J, Figueres L, Bobot M, de Laforcade L, Ayari H, Dolley-Hitze T, Gueutin V, Braconnier A, Golbin L, Citarda S, Seret G, Belaid L, Cohen R, Luque Y, Larceneux F, Seervai RNH, Overs C, Bertocchio JP; Club des Jeunes Nephrologues. Sodium Bicarbonate Prescription and Extracellular Volume Increase: Real-world Data Results from the AlcalUN Study. Clin Pharmacol Ther. 2022 Jan;111(1):252-262. doi: 10.1002/cpt.2427. Epub 2021 Oct 11.

    PubMed 34564842

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alkali in people with Metabolic Acidosis and Nephrolithiasis, run by Jean-Philippe Bertocchio at 18 sites in France.

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 2 inclusion and 1 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Extracellular compartment M3 (time frame: At M3 (month 3)). 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 NCT03035812, which also lists 1 linked publication.

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 14 Jul 2020.

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