Clinical trial NCT02746133: Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-027-CNI)
Official title: Characterisation of Patient Profile and Contemporary Treatment of Pre-dialytic Chronic Kidney Disease (CKD) in Patients Receiving a Restricted Protein Diet Supplemented With Ketosteril® - a Drug Utilisation Study (DUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-dialytic chronic kidney disease patients treated at nephrology units of selected hospitals in Russia

Brief summary: The purpose of this study is to characterise the patient and disease profile under the influence of a protein-restricted diet supplemented with keto acids/amino acids (KA/AA), focusing on the progression of chronic renal insufficiency, calcium and phosphorus metabolism, nutritional status, patient compliance to diet and Ketosteril intake as well as the persistent dietary education to ensure compliance in a large group of pre-dialysis patients.


Eligibility criteria: Inclusion Criteria:

* written informed consent
* non-dialyzed patients with CKD
* indication for Ketosteril according to Summary of Product Characteristics (SmPC), including a glomerular filtration rate (GFR) \< 25 mL/min
* accepted supplemented protein-restricted diet and newly starting with Ketosteril (treatment naïve, i.e., never treated with Ketosteril before)
* adult patients ≥ 18 years

Exclusion Criteria:

* active cancer diseases
* pregnancy or breast feeding
* hypersensitivity to active substances or to any of the excipients in Ketosteril
* hypercalcaemia
* major disorder of amino acid metabolism, e.g., hereditary diseases
* participation in any clinical trial with an investigational drug within 30 days prior to start of study or during the study
* illiteracy or incapability to read or write

Primary outcomes:
measure: Patient compliance to Ketosteril (number of tablets taken; patient reported)
timeFrame: 12 months
Secondary outcomes:
measure: Patient compliance to diet (protein and energy intake; investigator and patient-reported, based on patient diary and a routine 3-day food diary)
timeFrame: Monthly, starting 1 month after enrolment, for a total of 12 months
measure: CKD stage (according to KDIGO guideline)
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Presence of comorbidities
timeFrame: At baseline
measure: Serum creatinine
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: 24h urinary protein
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Urinary microalbumin
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum urea
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Creatinine clearance
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Glomerular filtration rate (GFR)
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Estimated GFR [eGFR]
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Fasting blood glucose
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Fasting plasma glucose
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Haemoglobin A1c [HbA1c]
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum triglyceride
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum cholesterol
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum high-density lipoprotein [HDL]
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum low-density lipoprotein [LDL]
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum calcium
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum phosphate
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum parathyroid hormone [PTH]
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Body weight
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Skinfold thickness
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum total protein
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum albumin
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum prealbumin
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Body mass index [BMI]
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Subjective global assessment [SGA]
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Decline in eGFR
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Worsening of CKD stage
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Start of dialysis
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Presence of a 50% reduction in eGFR
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum bicarbonate
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum haemoglobin
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Serum potassium
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Reported nausea and vomiting
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Presence of concomitant disease
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Administration of concomitant medication
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Discontinuation of diet and Ketosteril with the reasons for discontinuation as reported by the investigator
timeFrame: Monthly, starting at 1 month after enrolment for up to 12 months
measure: Acceptance of diet as documented in the patient diary
timeFrame: Daily, for up to 12 months
measure: Appetite change as documented in the patient diary
timeFrame: Daily, for up to 12 months
measure: Change of food intake as documented in the patient diary
timeFrame: Daily, for up to 12 months
measure: Adverse events including adverse drug reactions and serious adverse events
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Blood pressure
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Heart rate
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
measure: Body temperature
timeFrame: At baseline and 3, 6, 9 and 12 months after enrolment
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
Study officials:
affiliation: St. Petersburg State Budgetary Healthcare Institution "Mariinskaya City Hospital",
name: Aleksander Y. Zemchenkov, MD
role: PRINCIPAL_INVESTIGATOR
References: