Nutritional Therapy to Prevent Progression of Acute Kidney Injury to Chronic Kidney Disease

NCT02831062 | Completed

• 1 other identifier: 151843
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Kidney Injury; Chronic Kidney Disease

Keywords

nutrition; progression

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• degree of recovery of renal function

  6 months

• rate of recovery of renal function

  6 months

• safety of the LPD-K diet

  6 months

Study Arms (2)

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.

Other: low protein diet + ketosteril

Interventions

low protein diet + ketosteril OTHER

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).

Low Protein Diet + Ketosteril

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Duration of stage 2/3 AKI episode ≥ 72 hrs and ≤ 21 days
• Total hospital stay ≤ 21 days

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Fresenius Kabi: collaborator

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic; Disease Progression

Interventions

Diet, Protein-Restricted; ketosteril

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: July 13, 2016
• Study Start: August 1, 2016
• Primary Completion: July 20, 2018
• Study Completion: December 31, 2018
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share