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Kidney DiseasesREMA-CKDNCT05784389

Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5

A study testing Low PRAL in people with Kidney Diseases and Metabolic Acidosis, run by Nordsjaellands Hospital at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This clinical trial aims to investigate and test the effect of an acid/base diet in chronic kidney disease (CKD) patients, CKD stage 4 and 5. The trial is guided by the hypothesis that an acid/base diet will reduce the degree of acidosis and simultaneously reduce the need for bicarbonate supplements. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Low PRAL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteDenmark
Study dates
27 Mar 2023to 20 Nov 2023
Phase
Interventional
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

  • Chronic acidosis (plasma-bicarbonate under 22 mmol/l at multiple measures within the last 12 months).
  • Diagnosed with non-dialysis needed chronic kidney disease in stage 4 and 5 (eGFR below 30 ml/min/1,73 m2)
  • Of legal age and over 18 of years
  • Understand danish and understand the written material
  • Able to cooperate about the diet
  • Able to take pictures with their phone or willing to learn

Who cannot join

  • Vegan and vegetarian with very low intake of animal protein (below 25 g/day)
  • Pregnant or breast feeding
  • Patients with short bowel syndrome, bricker bladder, pancreatitis or any other known malabsorption problem
  • Potassium above 5 mmol/l
  • Ongoing infection

Trial locations and contacts

1 site in 1 country.

Louise H Salomo, Doctor Med contact

48293392

louise.havkrog.salomo@regionh.dk

Denmark1 site, 1 recruiting

  • Nordshjaellands Hospital

    Hillerød, 3400

    Nordshjaellands Hospital

    Anna Elvina W Pedersen, Stud. scient

    Recruiting

Other trials in Denmark

About this study

This clinical trial aims to investigate and test the effect of an acid/base diet in chronic kidney disease (CKD) patients, CKD stage 4 and 5. The trial is guided by the hypothesis that an acid/base diet will reduce the degree of acidosis and simultaneously reduce the need for bicarbonate supplements.

Read the detailed description

Observational studies indicate that diets with a low "potential renal acid load (PRAL)" is associated with a lower serum-bicarbonate value. Therefore, we aim to investigate this association through an interventional study design.

Participants will be asked to follow a restricted diet with a low "PRAL" during a 6-week trial divided into three periods: two-week of free-living control, two-weeks of intervention, and a two-week free-living follow-up.

The PRAL calculation tool will be used to create a diet low in acid and to develop individualized diet plans for each patient. The diet will comply with Danish national guidelines on threshold for potassium and protein, due to the high risk of hyperkalemia in CKD patients. The patients will be asked to document their food and drink intake by taking pictures of their plates and cups before and after a meal, over a 24-hour period.

Being tested
Low PRAL
Keywords
Potential renal acid load, PRAL, Study design, Diet, Humans, Elderly, Bicarbonate/blood, Muscle strength, Hand strength, Chair stand test, Calorimetry, indirect, Bone mineralization, Carbon dioxide/blood, Phosphor/urine, Potassium/urine, Urea/blood, Urea/urine
Medical subject headings
Kidney Diseases, Acidosis, Renal Insufficiency

What participants receive

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

  • Low PRALOther

    Two weeks on a low PRAL diet compared to 2 week free living

Study groups in NCT05784389
Study groupRoleWhat they receive
Low PRAL dietExperimentalExperimental: Low PRAL diet Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
Receives: Other: Low PRAL

What is being measured

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

  1. Plasma-total carbon dioxide (CO2)

    mmol/l

    Measured: 6 weeks

Secondary outcomes (19)

  1. Plasma-alkaline phosphatase

    U/l

    Measured: 6 weeks

  2. Plasma-sodium ion

    mmol/l

    Measured: 6 weeks

  3. Plasma-creatinine

    umol/l

    Measured: 6 weeks

  4. Plasma-parathyroid hormone

    pmol/l

    Measured: 6 weeks

  5. Plasma-carbamide

    mmol/l

    Measured: 6 weeks

  6. Plasma-albumin

    g/l

    Measured: 6 weeks

  7. Urine-phosphorous

    mmol/d

    Measured: 6 weeks

  8. Urine-sodium

    mmol/d

    Measured: 6 weeks

  9. Urine-potassium

    mmol/d

    Measured: 6 weeks

  10. Urine-carbamide

    mmol/d

    Measured: 6 weeks

  11. Urine-albumin

    mg/d

    Measured: 6 weeks

  12. Urine-magnesium

    mmol/d

    Measured: 6 weeks

  13. Urine-creatinine

    mmol/d

    Measured: 6 weeks

  14. Urine-calcium

    mmol/d

    Measured: 6 weeks

  15. Total acid excretion in urine

    mmol/d

    Measured: 6 weeks

  16. Urine-pH

    pH

    Measured: 6 weeks

  17. Urine ammonium-ion (NH4+) excretion

    mmol/d

    Measured: 6 weeks

  18. Urine net acid excretion

    mmol/d

    Measured: 6 weeks

  19. Urine bicarbonate

    mmol/l

    Measured: 6 weeks

Timeline

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

  1. First posted24 Mar 2023
  2. Study start27 Mar 2023
  3. Primary completion20 Jun 2023 (estimated)
  4. Study completion20 Nov 2023 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05784389
Sponsor's protocol ID
H-21069570
Acronym
REMA-CKD
Status last verified
Mar 2023
First submitted
13 Mar 2023
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: sharing is not currently possible recording to legislation and consent form.

Questions about this trial

What is this clinical trial studying?

A study testing Low PRAL in people with Kidney Diseases and Metabolic Acidosis, run by Nordsjaellands Hospital at 1 site in Denmark.

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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. 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 Denmark. 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.

Are results available for this study?

Results are not available in the source record.

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

Contact Louise H Salomo, Doctor Med (48293392, louise.havkrog.salomo@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma-total carbon dioxide (CO2) (time frame: 6 weeks). 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 NCT05784389.

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 29 Mar 2023.

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