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Completed

NCT Number: NCT02649205

Observational Study on Chronic Kidney Disease Treatment With a Ketosteril Supplemented Protein-restricted Diet

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Velencei-tavi Kistérségi Járóbeteg Szakellátó Közhasznú Nonprofit Kft

Velence, 2481, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational study: Supplemented protein-restricted diet

Other

Observational study: Supplemented protein-restricted diet

Primary outcomes

  1. Patient compliance to Ketosteril (number of tablets taken; patient-reported)

    Time frame: Daily, for a total of 12 months

    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.

Secondary outcomes

  1. Patient compliance to diet (protein and energy intake, based on a routine 3-day food diary)

    Time frame: Monthly starting 1 month after enrolment, for a total of 12 months

    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.

  2. CKD stage (according to KDIGO guideline)

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  3. Presence of comorbidities

    Time frame: At baseline

    e.g., diabetes, hypertension, metabolic syndrome

  4. Serum creatinine

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  5. 24h urinary protein

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  6. Urinary microalbumin

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  7. Serum urea

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  8. Creatinine clearance

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  9. Glomerular filtration rate (GFR)

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  10. Estimated glomerular filtration rate (eGFR)

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  11. Fasting blood glucose

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  12. Fasting plasma glucose

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  13. HbA1c

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  14. Serum triglyceride

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  15. Serum cholesterol

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  16. Serum high-density lipoprotein (HDL)

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  17. Serum low-density lipoprotein (LDL)

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  18. Serum calcium

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  19. Serum phosphate

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  20. Serum parathyroid hormone

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  21. Weight

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

    Total body weight

  22. Skinfold thickness

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  23. Serum total protein

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  24. Serum albumin

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  25. Serum prealbumin

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  26. Body mass index

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

  27. Subjective Global Assessment

    Time frame: At baseline and 3, 6, 9 and 12 months after enrolment

    Final result/score to be reported

  28. Decline in eGFR

    Time frame: At 3, 6, 9 and 12 months after enrolment

  29. Worsening of CKD stage

    Time frame: At 3, 6, 9 and 12 months after enrolment

  30. Start of dialysis

    Time frame: At 3, 6, 9 and 12 months after enrolment

  31. Presence of a 50% reduction in eGFR

    Time frame: At 3, 6, 9 and 12 months after enrolment

  32. Serum bicarbonate

    Time frame: At baseline and 3, 6 and 12 months after enrolment

  33. Serum haemoglobin

    Time frame: At baseline and 3, 6 and 12 months after enrolment

  34. Serum potassium

    Time frame: At baseline and 3, 6 and 12 months after enrolment

  35. Reported nausea and vomiting

    Time frame: At baseline and 3, 6 and 12 months after enrolment

  36. Presence of concomitant disease

    Time frame: At 3, 6, 9 and 12 months after enrolment

  37. Administration of concomitant medication

    Time frame: At 3, 6, 9 and 12 months after enrolment

  38. Discontinuation of diet and Ketosteril with the reasons for discontinuation as reported by the investigator

    Time frame: Monthly starting at 1 month after enrolment for up to 12 months

  39. Acceptance of diet as documented in the patient diary

    Time frame: Daily for up to 12 months

  40. Appetite change as documented in the patient diary

    Time frame: Daily for up to 12 months

  41. Change of food intake as documented in the patient diary

    Time frame: Daily for up to 12 months

  42. Adverse events including adverse drug reactions and serious adverse events

    Time frame: At 3, 6, 9 and 12 months after enrolment

  43. Blood pressure

    Time frame: At baseline and 3, 6, 9 and at 12 months after enrolment

  44. Heart rate

    Time frame: At baseline and 3, 6, 9 and at 12 months after enrolment

  45. Body temperature

    Time frame: At baseline and 3, 6, 9 and at 12 months after enrolment

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 7, 2016
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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