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Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5 (REMA-CKD)

Primary Purpose

Kidney Diseases, Metabolic Acidosis, Renal Insufficiency

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low PRAL
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Diseases focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Nordshjaellands Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low PRAL diet

Arm Description

Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).

Outcomes

Primary Outcome Measures

Plasma-total CO2
mmol/l

Secondary Outcome Measures

Plasma-alkaline phosphatase
U/l
Plasma-sodium ion
mmol/l
Plasma-creatinine
umol/l
Plasma-parathyroid hormone
pmol/l
Plasma-carbamide
mmol/l
Plasma-albumin
g/l
Urine-phosphorous
mmol/d
Urine-sodium
mmol/d
Urine-potassium
mmol/d
Urine-carbamide
mmol/d
Urine-albumin
mg/d
Urine-magnesium
mmol/d
Urine-creatinine
mmol/d
Uirne-calcium
mmol/d
Total acid excretion in urine
Urine-pH
Urine NH4+ excretion
Urine net acid excretion
Urine bicarbonate
mmol/l

Full Information

First Posted
July 23, 2023
Last Updated
July 23, 2023
Sponsor
University of Copenhagen
Collaborators
Nordsjaellands Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05970094
Brief Title
Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
Acronym
REMA-CKD
Official Title
Reduction of Metabolic Acidosis in Patients With Chronic Kidney Disease in Stage 4 and 5
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
August 20, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Copenhagen
Collaborators
Nordsjaellands Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. Our 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-bicarobante value. Therefore we aim 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 recieve individual diet plans. The diet will comply with national treshold guidlines 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Metabolic Acidosis, Renal Insufficiency, CKD, Pre-dialysis
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low PRAL diet
Arm Type
Experimental
Arm Description
Crossover design: 1 arm consisting of three consecutive periods of two weeks (control, intervention and follow up).
Intervention Type
Other
Intervention Name(s)
Low PRAL
Intervention Description
Two weeks on a low PRAL diet compared to 2 week free living
Primary Outcome Measure Information:
Title
Plasma-total CO2
Description
mmol/l
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Plasma-alkaline phosphatase
Description
U/l
Time Frame
6 weeks
Title
Plasma-sodium ion
Description
mmol/l
Time Frame
6 weeks
Title
Plasma-creatinine
Description
umol/l
Time Frame
6 weeks
Title
Plasma-parathyroid hormone
Description
pmol/l
Time Frame
6 weeks
Title
Plasma-carbamide
Description
mmol/l
Time Frame
6 weeks
Title
Plasma-albumin
Description
g/l
Time Frame
6 weeks
Title
Urine-phosphorous
Description
mmol/d
Time Frame
6 weeks
Title
Urine-sodium
Description
mmol/d
Time Frame
6 weeks
Title
Urine-potassium
Description
mmol/d
Time Frame
6 weeks
Title
Urine-carbamide
Description
mmol/d
Time Frame
6 weeks
Title
Urine-albumin
Description
mg/d
Time Frame
6 weeks
Title
Urine-magnesium
Description
mmol/d
Time Frame
6 weeks
Title
Urine-creatinine
Description
mmol/d
Time Frame
6 weeks
Title
Uirne-calcium
Description
mmol/d
Time Frame
6 weeks
Title
Total acid excretion in urine
Time Frame
6 weeks
Title
Urine-pH
Time Frame
6 weeks
Title
Urine NH4+ excretion
Time Frame
6 weeks
Title
Urine net acid excretion
Time Frame
6 weeks
Title
Urine bicarbonate
Description
mmol/l
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Plasma-Potassium
Description
mmol/l
Time Frame
6 weeks
Title
Plasma-calcium
Description
mmol/l
Time Frame
6 weeks
Title
Plasma-magnesium
Description
mmol/l
Time Frame
6 weeks
Title
Plasma-inorganic phosphorous
Description
mmol/l
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Nordshjaellands Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Currently no plans for sharing

Learn more about this trial

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

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