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Nutritional Therapy to Prevent Progression of Acute Kidney Injury to Chronic Kidney Disease (NutriAKI)

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ClinicalTrials.gov Identifier: NCT02831062
Recruitment Status : Unknown
Verified July 2016 by Ravindra Mehta, University of California, San Diego.
Recruitment status was:  Not yet recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Collaborator:
Fresenius Kabi
Information provided by (Responsible Party):
Ravindra Mehta, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Chronic Kidney Disease Other: low protein diet + ketosteril Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nutritional Therapy to Prevent Progression of Acute Kidney Injury to Chronic Kidney Disease
Study Start Date : August 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: ad lib diet
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.
Experimental: Low Protein Diet + Ketosteril
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.
Other: low protein diet + ketosteril
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. degree of recovery of renal function [ Time Frame: 6 months ]

    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.

  2. rate of recovery of renal function [ Time Frame: 6 months ]
    Slope of renal function recovery using baseline estimated GFR as reference.

  3. safety of the LPD-K diet [ Time Frame: 6 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Ravindra Mehta, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02831062    
Other Study ID Numbers: 151843
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual data will not be shared
Keywords provided by Ravindra Mehta, University of California, San Diego:
nutrition
progression
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Acute Kidney Injury
Disease Progression
Wounds and Injuries
Urologic Diseases
Renal Insufficiency
Disease Attributes
Pathologic Processes