Kidney DiseasesREMA-CKDNCT05970094
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 University of Copenhagen at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to learn about and test the effect of an acid/base diet, in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a historical control. The hypothesize is, that an acid/base diet will reduce the degree of acidosis and the need for oral bicarbonate supplements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases, Metabolic Acidosis, Renal Insufficiency
- 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
- 6 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-bicarbonat 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, brickre's bladder, pancreatitis or any other known malabsorption problem
- Potassium above 5 mmol/l
- Ongoing infection
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn about and test the effect of an acid/base diet, in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a historical control.
The hypothesize is, that an acid/base diet will reduce the degree of acidosis and the need for oral 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. The aim is to investigate this association with an interventional studydesign.
Participants will be asked to follow a restricted diet with a low "PRAL" during a 6 week trial divided in three periodes: two week free living control, two week intervention and a two week free living follow-up.
The PRAL calculation tool will be used to create a diet low in acid, based on this the patients will receive individual diet plans. The diet will comply with national treshold guidelines for potassium and protein, this is due to the high risk of hyperkalemia in patients with chronic kidney disease. 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.
- Conditions
- Kidney Diseases, Metabolic Acidosis, Renal Insufficiency, CKD, Pre-dialysis
- 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 group | Role | What they receive |
|---|---|---|
| Low PRAL diet | Experimental | 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.
Plasma-total CO2
mmol/l
Measured: 6 weeks
Secondary outcomes (19)
Plasma-alkaline phosphatase
U/l
Measured: 6 weeks
Plasma-sodium ion
mmol/l
Measured: 6 weeks
Plasma-creatinine
umol/l
Measured: 6 weeks
Plasma-parathyroid hormone
pmol/l
Measured: 6 weeks
Plasma-carbamide
mmol/l
Measured: 6 weeks
Plasma-albumin
g/l
Measured: 6 weeks
Urine-phosphorous
mmol/d
Measured: 6 weeks
Urine-sodium
mmol/d
Measured: 6 weeks
Urine-potassium
mmol/d
Measured: 6 weeks
Urine-carbamide
mmol/d
Measured: 6 weeks
Urine-albumin
mg/d
Measured: 6 weeks
Urine-magnesium
mmol/d
Measured: 6 weeks
Urine-creatinine
mmol/d
Measured: 6 weeks
Uirne-calcium
mmol/d
Measured: 6 weeks
Total acid excretion in urine
meqv/day
Measured: 6 weeks
Urine-pH
Units
Measured: 6 weeks
Urine NH4+ excretion
mmol/day
Measured: 6 weeks
Urine net acid excretion
meqv/day
Measured: 6 weeks
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.
- First posted1 Aug 2023
- Study start6 Mar 2023
- Primary completion20 Aug 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Nordsjaellands Hospital
- Responsible party
- Sponsor
- Investigators
- Jens Rikardt Andersen, MD, MPA, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970094
- Sponsor's protocol ID
- H-21069570
- Acronym
- REMA-CKD
- Status last verified
- Nov 2023
- First submitted
- 23 Jul 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently no plans for sharing
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
- ClinicalTrials.gov ID
- NCT05970094
- Acronym / sponsor ID
- REMA-CKD / H-21069570
- Conditions
- Kidney Diseases, Metabolic Acidosis, Renal Insufficiency, CKD, Pre-dialysis
- Keywords
- Potential renal acid load, PRAL, Study design, Diet, Humans, Elderly, Bicarbonate/blood, Muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Nordsjaellands Hospital
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about and test the effect of an acid/base diet, in chronic kidney patients with CKD stage 4 and 5 in an interventional study with a historical control.
The hypothesize is, that an acid/base diet will reduce the degree of acidosis and the need for oral bicarbonate supplements.
Detailed description
Observational studies indicate that diets with a low "potential renal acid load (PRAL)" is associated with a lower serum-bicarbonate value. The aim is to investigate this association with an interventional studydesign.
Participants will be asked to follow a restricted diet with a low "PRAL" during a 6 week trial divided in three periodes: two week free living control, two week intervention and a two week free living follow-up.
The PRAL calculation tool will be used to create a diet low in acid, based on this the patients will receive individual diet plans. The diet will comply with national treshold guidelines for potassium and protein, this is due to the high risk of hyperkalemia in patients with chronic kidney disease. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
| Arm | Type | Receives |
|---|---|---|
| Low PRAL diet | Experimental | Other: Low PRALCrossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic acidosis (plasma-bicarbonat 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
Key exclusion criteria (5 listed)
- Vegan and vegetarian with very low intake of animal protein (below 25 g/day)
- Pregnant or breast feeding
- Patients with short bowel syndrome, brickre's bladder, pancreatitis or any other known malabsorption problem
- Potassium above 5 mmol/l
- Ongoing infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low PRALTwo weeks on a low PRAL diet compared to 2 week free living | Other | Low PRAL diet |
Primary outcome
Plasma-total CO2
Time frame: 6 weeks
mmol/l
19 secondary outcomes
Plasma-alkaline phosphatase
Time frame: 6 weeks
Plasma-sodium ion
Time frame: 6 weeks
Plasma-creatinine
Time frame: 6 weeks
Plasma-parathyroid hormone
Time frame: 6 weeks
Plasma-carbamide
Time frame: 6 weeks
Plasma-albumin
Time frame: 6 weeks
Urine-phosphorous
Time frame: 6 weeks
Urine-sodium
Time frame: 6 weeks
Urine-potassium
Time frame: 6 weeks
Urine-carbamide
Time frame: 6 weeks
Urine-albumin
Time frame: 6 weeks
Urine-magnesium
Time frame: 6 weeks
Urine-creatinine
Time frame: 6 weeks
Uirne-calcium
Time frame: 6 weeks
Total acid excretion in urine
Time frame: 6 weeks
Urine-pH
Time frame: 6 weeks
Urine NH4+ excretion
Time frame: 6 weeks
Urine net acid excretion
Time frame: 6 weeks
Urine bicarbonate
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No. Currently no plans for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Rikardt Andersen, MD, MPA study director
University of Copenhagen
1 site in 1 country: see every site and its status.
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 University of Copenhagen 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: finished, as of the sponsor's last update on 4 Dec 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?
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?
Plasma-total 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?
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 4 Dec 2023.