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Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)

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ClinicalTrials.gov Identifier: NCT02756520
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi

Study Description
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Brief Summary:
The purpose of this study is to characterize 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.

Condition or disease Intervention/treatment
Chronic Kidney Disease Other: Observational study: Supplemented protein-restricted diet

Study Design
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Study Type : Observational
Actual Enrollment : 154 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : September 2016
Actual Primary Completion Date : October 10, 2018
Actual Study Completion Date : October 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Patient compliance to Ketosteril (number of tablets taken; patient reported) [ Time Frame: 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.

    Patient compliance to Ketosteril will be assessed daily, for a total of 12 months.



Secondary Outcome Measures :
  1. Patient compliance to diet (protein and energy intake; investigator and patient-reported, based on patient diary and 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 Kidney Disease Improving Global Outcomes [KDIGO] guideline) [ Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment ]
  3. Presence of comorbidities [ Time Frame: At baseline ]
  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 GFR (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. Haemoglobin A1c (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 (PTH) [ Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment ]
  21. Body weight [ Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment ]
  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 (BMI) [ Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment ]
  27. Subjective global assessment (SGA) [ Time Frame: At baseline and 3, 6, 9 and 12 months after enrolment ]
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pre-dialytic chronic kidney disease patients treated at nephrology units of selected hospitals in China
Criteria

Inclusion Criteria:

  • written informed consent
  • non-dialyzed patients with CKD
  • indication for Ketosteril according to package insert (PI), 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756520


Locations
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China, Beijing
Prof. Xiangmei
Beijing, Beijing, China
Sponsors and Collaborators
Fresenius Kabi
More Information
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Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT02756520    
Other Study ID Numbers: Keto-024-CNI
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Keywords provided by Fresenius Kabi:
chronic kidney disease, pre-dialytic
Ketosteril, keto-acids
diet, protein-restricted
renal function
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency