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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
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low PRAL
Sponsored by
Nordsjaellands Hospital
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-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 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, bricker bladder, pancreatitis or any other known malabsorption problem Potassium above 5 mmol/l Ongoing infection

Sites / Locations

  • Nordshjaellands HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low PRAL diet

Arm Description

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

Outcomes

Primary Outcome Measures

Plasma-total carbon dioxide (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
Urine-calcium
mmol/d
Total acid excretion in urine
mmol/d
Urine-pH
pH
Urine ammonium-ion (NH4+) excretion
mmol/d
Urine net acid excretion
mmol/d
Urine bicarbonate
mmol/l

Full Information

First Posted
March 13, 2023
Last Updated
March 27, 2023
Sponsor
Nordsjaellands Hospital
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT05784389
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
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
June 20, 2023 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

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

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
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.
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.

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
Single Group Assignment 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 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low PRAL diet
Arm Type
Experimental
Arm Description
Experimental: Low PRAL diet 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 carbon dioxide (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
Urine-calcium
Description
mmol/d
Time Frame
6 weeks
Title
Total acid excretion in urine
Description
mmol/d
Time Frame
6 weeks
Title
Urine-pH
Description
pH
Time Frame
6 weeks
Title
Urine ammonium-ion (NH4+) excretion
Description
mmol/d
Time Frame
6 weeks
Title
Urine net acid excretion
Description
mmol/d
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-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 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, bricker bladder, pancreatitis or any other known malabsorption problem Potassium above 5 mmol/l Ongoing infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louise H Salomo, Doctor Med
Phone
48293392
Email
louise.havkrog.salomo@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisbet Brandi, Doctor Med
Organizational Affiliation
Nordsjaellands Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jens R Andersen, As. prof.
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nordshjaellands Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nordshjaellands Hospital
First Name & Middle Initial & Last Name & Degree
Anna Elvina W Pedersen, Stud. scient
First Name & Middle Initial & Last Name & Degree
Julie F Christensen, Stud. scient

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
sharing is not currently possible recording to legislation and consent form.

Learn more about this trial

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

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