Back to resultsNutritional Therapy to Prevent Progression of Acute Kidney Injury to Chronic Kidney Disease (NutriAKI)
Primary Purpose
Acute Kidney Injury, Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
low protein diet + ketosteril
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury focused on measuring nutrition, progression
Eligibility Criteria
Inclusion Criteria:
- Duration of stage 2/3 AKI episode ≥ 72 hrs and ≤ 21 days
- Total hospital stay ≤ 21 days
Exclusion Criteria:
- Baseline Chronic Kidney Disease Stage 4 or higher (estimated Glomerular Filtration Rate (eGFR)) <30ml/min/1.73m2) prior to their AKI episode
- Patients dialysis dependent at hospital discharge
- Dialysis dependency > 14 days at time of enrolment
eGFR exclusion criteria:
- for patients that required dialysis during hospital stay - measured GFR less than 15ml/min and/or urine output less than 500ml at hospital discharge
- for patients with known baseline serum creatinine (SCr) - renal recovery with an eGFR more than 80% from baseline at hospital discharge
- for patients with unknown previous renal function - eGFR > 60ml/min/1.73m2 at time of hospital discharge
- Suspected or biopsy proven glomerulonephritis as cause of AKI
- Obstructive nephropathy as cause of AKI.
- Kidney transplant recipient and patients in the kidney transplant list
- Chronic liver disease
- High likelihood of re-hospitalization or death in the following 6 months, ascertained by physician in charge of the patient.
- Hypercalcemia - Ca > within one standard deviation of reference level upper limit or albumin corrected
- Lactating or pregnant woman or woman planning to become pregnant within the timeframe of the study
- Inability to follow up study procedures for at least 6 months
- Unwillingness to give consent
- Institutionalized individuals (prisoners, significant mental illness, or nursing home residents)
- Body weight <70% or >150% of standard body weight
- History of phenylketonuria or other major disorder of amino acid metabolism
- Hypersensitivity to the active substances or to any of the excipients of Ketosteril.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
ad lib diet
Low Protein Diet + Ketosteril
Arm Description
Patients who have an episode of Stage 2/3 AKI and are followed in a focused post-AKI clinic. Patients will be asked to continue on their regular diet and the protein and caloric ingestion will be recorded at each visit.
Patients who have an episode of Stage 2/3 AKI and are followed in a focused post-AKI clinic. Patients in this arm will be prescribed a low protein diet (LPD) and +Ketosteril supplementation, containing 0.6 g protein/kg per day, phosphorus 5-10 mg/kg/day, Ketosteril 1 capsule per 5 kg body weight/day divided over three doses (max 8 capsules per dose). Protein and caloric ingestion will be recorded.
Outcomes
Primary Outcome Measures
feasibility of the LPD-K diet
Feasibility: assess the compliance with diet and drug. Compliance to the assigned protein prescription will be estimated at each visit during the intervention period by nutrient intake data obtained from 3-day food records and the estimated protein intake calculated from urinary nitrogen appearance in 24-hour urine samples. Treatment compliance will be assessed by counting returned tablets.
Secondary Outcome Measures
degree of recovery of renal function
percentage of renal function recovery using baseline estimated GFR as reference. Recovery will be considered as
Complete: return of SCr by no less 20% from baseline in patients with known previous renal function. For patients without previous renal function, we will consider complete recovery if measured GFR more or equal to 90ml/min/1.73m2 .
Partial: return of SCr less than 20% from baseline in dialysis independent patients. For patients without previous renal function, we will consider partial recovery if measured GFR less than 90ml/min/1.73m2.
rate of recovery of renal function
Slope of renal function recovery using baseline estimated GFR as reference.
safety of the LPD-K diet
Evaluate adverse events related to ketosteril by monitoring serum calcium levels at each visit to determine the development of hypercalcemia Serum calcium levels > 10.5 mg/dl
Full Information
NCT ID
NCT02831062
First Posted
May 5, 2016
Last Updated
July 24, 2020
Sponsor
University of California, San Diego
Collaborators
Fresenius Kabi
1. Study Identification
Unique Protocol Identification Number
NCT02831062
Brief Title
Nutritional Therapy to Prevent Progression of Acute Kidney Injury to Chronic Kidney Disease
Acronym
NutriAKI
Official Title
Nutritional Therapy to Prevent Progression of Acute Kidney Injury to Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
July 20, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Fresenius Kabi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate patients who have an episode of moderate to severe acute kidney injury (AKI) and are followed in a focused post-AKI clinic. After patients present signs of kidney recovery and before hospital discharge, patients who give consent will be enrolled in the study. At the first post-AKI clinic visit, patients will be randomly allocated to follow a normal (ad-lib) or a low protein diet (LPD) for 3 months. Patients allocated to a LPD will receive a drug called Ketosteril. This drug allows the intake of essential amino acids while minimizing the amino-nitrogen intake, what in excess, can be bad for the recovered kidney. The investigators will evaluate the nutritional parameters and the kidney recovery of all patients and compare these parameters in those two groups.
Detailed Description
This is a pilot single center, randomized controlled, trial of patients who have an episode of Stage 2/3 AKI and are followed in a focused post-AKI clinic. Patients will be randomize to either; a. LPD-K diet containing 0.6 g protein/kg per day, phosphorus 5-10 mg/kg/day, Ketosteril 1 capsule per 5 kg body weight/day divided over three doses (max 8 capsules per dose) or b. ad lib diet. Ketosteril should be takes daily during meals and the tablets must not be chewed. Ingestion during meals facilitates proper absorption and the metabolisation into the corresponding amino acids.
After the initial assessment, those randomized to LPD-K will be on this diet for a maximum of 90 days. Additional interventions will include dietary counselling and questionnaire in both groups. We would aim for maintaining serum bicarbonate levels ≥ 22meq/L in both groups.
Evaluation of renal function will be performed using blood and urine tests. In addition, specimens will be collected in a bio-repository, and tested for biomarkers of renal structural damage. Comprehensive nutritional assessment will be performed by a dietitian, along with bioelectrical impedance measurements, blood and urine tests. 24-hour urine urea nitrogen and food records will be used to estimate the protein intake of each individual. Quality of well-being will be assessed using a standardized tool such as Euro Quality of Life (EQ-5D), Charlson Index, and Short Form 8 (SF8) or equivalent. Relevant clinical events (adherence to follow-up, death, hospitalization, renal recovery, repeat AKI episodes) will be tracked throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Chronic Kidney Disease
Keywords
nutrition, progression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ad lib diet
Arm Type
No Intervention
Arm Description
Patients who have an episode of Stage 2/3 AKI and are followed in a focused post-AKI clinic. Patients will be asked to continue on their regular diet and the protein and caloric ingestion will be recorded at each visit.
Arm Title
Low Protein Diet + Ketosteril
Arm Type
Experimental
Arm Description
Patients who have an episode of Stage 2/3 AKI and are followed in a focused post-AKI clinic. Patients in this arm will be prescribed a low protein diet (LPD) and +Ketosteril supplementation, containing 0.6 g protein/kg per day, phosphorus 5-10 mg/kg/day, Ketosteril 1 capsule per 5 kg body weight/day divided over three doses (max 8 capsules per dose). Protein and caloric ingestion will be recorded.
Intervention Type
Other
Intervention Name(s)
low protein diet + ketosteril
Intervention Description
Patients will follow a diet containing 0.6 g protein/kg per day, phosphorus 5-10 mg/kg/day, Ketosteril 1 capsule per 5 kg body weight/day divided over three doses (max 8 capsules per dose).
Primary Outcome Measure Information:
Title
feasibility of the LPD-K diet
Description
Feasibility: assess the compliance with diet and drug. Compliance to the assigned protein prescription will be estimated at each visit during the intervention period by nutrient intake data obtained from 3-day food records and the estimated protein intake calculated from urinary nitrogen appearance in 24-hour urine samples. Treatment compliance will be assessed by counting returned tablets.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
degree of recovery of renal function
Description
percentage of renal function recovery using baseline estimated GFR as reference. Recovery will be considered as
Complete: return of SCr by no less 20% from baseline in patients with known previous renal function. For patients without previous renal function, we will consider complete recovery if measured GFR more or equal to 90ml/min/1.73m2 .
Partial: return of SCr less than 20% from baseline in dialysis independent patients. For patients without previous renal function, we will consider partial recovery if measured GFR less than 90ml/min/1.73m2.
Time Frame
6 months
Title
rate of recovery of renal function
Description
Slope of renal function recovery using baseline estimated GFR as reference.
Time Frame
6 months
Title
safety of the LPD-K diet
Description
Evaluate adverse events related to ketosteril by monitoring serum calcium levels at each visit to determine the development of hypercalcemia Serum calcium levels > 10.5 mg/dl
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Duration of stage 2/3 AKI episode ≥ 72 hrs and ≤ 21 days
Total hospital stay ≤ 21 days
Exclusion Criteria:
Baseline Chronic Kidney Disease Stage 4 or higher (estimated Glomerular Filtration Rate (eGFR)) <30ml/min/1.73m2) prior to their AKI episode
Patients dialysis dependent at hospital discharge
Dialysis dependency > 14 days at time of enrolment
eGFR exclusion criteria:
for patients that required dialysis during hospital stay - measured GFR less than 15ml/min and/or urine output less than 500ml at hospital discharge
for patients with known baseline serum creatinine (SCr) - renal recovery with an eGFR more than 80% from baseline at hospital discharge
for patients with unknown previous renal function - eGFR > 60ml/min/1.73m2 at time of hospital discharge
Suspected or biopsy proven glomerulonephritis as cause of AKI
Obstructive nephropathy as cause of AKI.
Kidney transplant recipient and patients in the kidney transplant list
Chronic liver disease
High likelihood of re-hospitalization or death in the following 6 months, ascertained by physician in charge of the patient.
Hypercalcemia - Ca > within one standard deviation of reference level upper limit or albumin corrected
Lactating or pregnant woman or woman planning to become pregnant within the timeframe of the study
Inability to follow up study procedures for at least 6 months
Unwillingness to give consent
Institutionalized individuals (prisoners, significant mental illness, or nursing home residents)
Body weight <70% or >150% of standard body weight
History of phenylketonuria or other major disorder of amino acid metabolism
Hypersensitivity to the active substances or to any of the excipients of Ketosteril.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
individual data will not be shared
Learn more about this trial
Nutritional Therapy to Prevent Progression of Acute Kidney Injury to Chronic Kidney Disease
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