Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-027-CNI)

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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Other: Observational study: Supplemented protein-restricted diet

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
  • Saint Petersburg, Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pre-dialytic chronic kidney disease patients treated at nephrology units of selected hospitals in Russia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic kidney disease (pre-dialysis); Observational study: Supplemented protein-restricted diet	Other: Observational study: Supplemented protein-restricted diet; Observational study: Supplemented protein-restricted diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient compliance to Ketosteril (number of tablets taken; patient reported)	This is an observational study aiming to characterise the Patient Profile and contemporary Treatment of pre-dialytic chronic kidney disease (CKD) in patients receiving a restricted Protein diet supplemented with Ketosteril®. There is no distinction between Primary and secondary outcome measures in the observational plan, and only Routine procedures are documented. Patient compliance to Ketosteril will be assessed daily, for a total of 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CKD stage (according to KDIGO guideline)		At baseline and 3, 6, 9 and 12 months after enrolment
Serum creatinine		At baseline and 3, 6, 9 and 12 months after enrolment
24h urinary protein		At baseline and 3, 6, 9 and 12 months after enrolment
Urinary microalbumin		At baseline and 3, 6, 9 and 12 months after enrolment
Serum urea		At baseline and 3, 6, 9 and 12 months after enrolment
Creatinine clearance		At baseline and 3, 6, 9 and 12 months after enrolment
Glomerular filtration rate (GFR)		At baseline and 3, 6, 9 and 12 months after enrolment
Fasting blood glucose		At baseline and 3, 6, 9 and 12 months after enrolment
Fasting plasma glucose		At baseline and 3, 6, 9 and 12 months after enrolment
Serum triglyceride		At baseline and 3, 6, 9 and 12 months after enrolment
Serum cholesterol		At baseline and 3, 6, 9 and 12 months after enrolment
Serum calcium		At baseline and 3, 6, 9 and 12 months after enrolment
Serum phosphate		At baseline and 3, 6, 9 and 12 months after enrolment
Skinfold thickness		At baseline and 3, 6, 9 and 12 months after enrolment
Serum total protein		At baseline and 3, 6, 9 and 12 months after enrolment
Serum albumin		At baseline and 3, 6, 9 and 12 months after enrolment
Serum prealbumin		At baseline and 3, 6, 9 and 12 months after enrolment
Presence of comorbidities		At baseline
Body weight		At baseline and 3, 6, 9 and 12 months after enrolment
Patient compliance to diet (protein and energy intake; investigator and patient-reported, based on patient diary and a routine 3-day food diary)	This is an observational study aiming to characterise the Patient Profile and contemporary Treatment of pre-dialytic chronic kidney disease (CKD) in patients receiving a restricted Protein diet supplemented with Ketosteril®. There is no distinction between Primary and secondary outcome measures in the observational plan, and only Routine procedures are documented.	Monthly, starting 1 month after enrolment, for a total of 12 months
Estimated GFR [eGFR]		At baseline and 3, 6, 9 and 12 months after enrolment
Haemoglobin A1c [HbA1c]		At baseline and 3, 6, 9 and 12 months after enrolment
Serum high-density lipoprotein [HDL]		At baseline and 3, 6, 9 and 12 months after enrolment
Serum low-density lipoprotein [LDL]		At baseline and 3, 6, 9 and 12 months after enrolment
Serum parathyroid hormone [PTH]		At baseline and 3, 6, 9 and 12 months after enrolment
Body mass index [BMI]		At baseline and 3, 6, 9 and 12 months after enrolment
Subjective global assessment [SGA]		At baseline and 3, 6, 9 and 12 months after enrolment
Decline in eGFR		At baseline and 3, 6, 9 and 12 months after enrolment
Worsening of CKD stage		At baseline and 3, 6, 9 and 12 months after enrolment
Start of dialysis		At baseline and 3, 6, 9 and 12 months after enrolment
Presence of a 50% reduction in eGFR		At baseline and 3, 6, 9 and 12 months after enrolment
Serum bicarbonate		At baseline and 3, 6, 9 and 12 months after enrolment
Serum haemoglobin		At baseline and 3, 6, 9 and 12 months after enrolment
Serum potassium		At baseline and 3, 6, 9 and 12 months after enrolment
Reported nausea and vomiting		At baseline and 3, 6, 9 and 12 months after enrolment
Presence of concomitant disease		At baseline and 3, 6, 9 and 12 months after enrolment
Administration of concomitant medication		At baseline and 3, 6, 9 and 12 months after enrolment
Discontinuation of diet and Ketosteril with the reasons for discontinuation as reported by the investigator		Monthly, starting at 1 month after enrolment for up to 12 months
Acceptance of diet as documented in the patient diary		Daily, for up to 12 months
Appetite change as documented in the patient diary		Daily, for up to 12 months
Change of food intake as documented in the patient diary		Daily, for up to 12 months
Adverse events including adverse drug reactions and serious adverse events		At baseline and 3, 6, 9 and 12 months after enrolment
Blood pressure		At baseline and 3, 6, 9 and 12 months after enrolment
Heart rate		At baseline and 3, 6, 9 and 12 months after enrolment
Body temperature		At baseline and 3, 6, 9 and 12 months after enrolment

Collaborators and Investigators

• Sponsor: Fresenius Kabi
• Investigators: Principal Investigator: Aleksander Y. Zemchenkov, MD, St. Petersburg State Budgetary Healthcare Institution "Mariinskaya City Hospital",

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 25, 2016
• Primary Completion (ACTUAL): December 28, 2018
• Study Completion (ACTUAL): January 14, 2019

Study Registration Dates

• First Submitted: April 6, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (ESTIMATE): April 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: Keto-027-CNI