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

Chronic Kidney Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746133
• Other study ID #: Keto-027-CNI
• Status: Completed
• Start date: July 25, 2016
• Est. completion date: January 14, 2019

Study information

• Verified date: January 2019
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 14, 2019
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Observational study: Supplemented protein-restricted diet
Observational study: Supplemented protein-restricted diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	CKD stage (according to KDIGO guideline)		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Presence of comorbidities		At baseline
Secondary	Serum creatinine		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	24h urinary protein		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Urinary microalbumin		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum urea		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Creatinine clearance		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Glomerular filtration rate (GFR)		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Estimated GFR [eGFR]		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Fasting blood glucose		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Fasting plasma glucose		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Haemoglobin A1c [HbA1c]		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum triglyceride		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum cholesterol		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum high-density lipoprotein [HDL]		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum low-density lipoprotein [LDL]		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum calcium		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum phosphate		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum parathyroid hormone [PTH]		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Body weight		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Skinfold thickness		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum total protein		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum albumin		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum prealbumin		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Body mass index [BMI]		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Subjective global assessment [SGA]		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Decline in eGFR		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Worsening of CKD stage		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Start of dialysis		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Presence of a 50% reduction in eGFR		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum bicarbonate		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum haemoglobin		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Serum potassium		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Reported nausea and vomiting		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Presence of concomitant disease		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Administration of concomitant medication		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	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
Secondary	Acceptance of diet as documented in the patient diary		Daily, for up to 12 months
Secondary	Appetite change as documented in the patient diary		Daily, for up to 12 months
Secondary	Change of food intake as documented in the patient diary		Daily, for up to 12 months
Secondary	Adverse events including adverse drug reactions and serious adverse events		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Blood pressure		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Heart rate		At baseline and 3, 6, 9 and 12 months after enrolment
Secondary	Body temperature		At baseline and 3, 6, 9 and 12 months after enrolment