Acute Kidney InjuryNutriAKINCT02831062
Nutritional Therapy to Prevent Progression of Acute Kidney Injury to Chronic Kidney Disease
A study testing low protein diet + ketosteril in people with Acute Kidney Injury and Chronic Kidney Disease, run by University of California, San Diego.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Kidney Injury, Chronic Kidney Disease
- What is being tested?
- low protein diet + ketosteril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 31 Dec 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Duration of stage 2/3 AKI episode ≥ 72 hrs and ≤ 21 days
- Total hospital stay ≤ 21 days
Who cannot join
- 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
Show all 20Show fewer
- 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.
About this study
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.
Read the 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.
- Conditions
- Acute Kidney Injury, Chronic Kidney Disease
- Being tested
- low protein diet + ketosteril
- Keywords
- nutrition, progression
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low protein diet + ketosterilOther
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).
| Study group | Role | What they receive |
|---|---|---|
| ad lib diet | No intervention | 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. |
| Low Protein Diet + Ketosteril | Experimental | 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. Receives: Other: low protein diet + ketosteril |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
rate of recovery of renal function
Slope of renal function recovery using baseline estimated GFR as reference.
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start1 Aug 2016
- Primary completion20 Jul 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi
- Responsible party
- Principal investigator, Ravindra Mehta, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831062
- Sponsor's protocol ID
- 151843
- Acronym
- NutriAKI
- Status last verified
- Jul 2020
- First submitted
- 5 May 2016
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: individual data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Therapy to Prevent Progression of Acute Kidney Injury to Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02831062
- Acronym / sponsor ID
- NutriAKI / 151843
- Conditions
- Acute Kidney Injury, Chronic Kidney Disease
- Keywords
- nutrition, progression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Jul 2016 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ad lib diet | No intervention | –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. |
| Low Protein Diet + Ketosteril | Experimental | Other: low protein diet + ketosterilPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Duration of stage 2/3 AKI episode ≥ 72 hrs and ≤ 21 days
- Total hospital stay ≤ 21 days
Key exclusion criteria (20 listed)
- 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:
- Suspected or biopsy proven glomerulonephritis as cause of AKI
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 protein diet + ketosterilPatients 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). | Other | Low Protein Diet + Ketosteril |
Primary outcome
feasibility of the LPD-K diet
Time frame: 6 months
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.
3 secondary outcomes
degree of recovery of renal function
Time frame: 6 months
rate of recovery of renal function
Time frame: 6 months
safety of the LPD-K diet
Time frame: 6 months
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 28 Jul 2020.
- Individual participant dataSharing planned: No. individual data will not be shared
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing low protein diet + ketosteril in people with Acute Kidney Injury and Chronic Kidney Disease, run by University of California, San Diego.
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 2 inclusion and 20 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 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
feasibility of the LPD-K diet (time frame: 6 months). 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 28 Jul 2020.