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

NCT ID: NCT02746133

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 85 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-25
• Study Completion Date: 2019-01-14

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.

Conditions

Chronic Kidney Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chronic kidney disease (pre-dialysis)

Observational study: Supplemented protein-restricted diet

Observational study: Supplemented protein-restricted diet

Intervention Type: OTHER

Observational study: Supplemented protein-restricted diet

Interventions

Observational study: Supplemented protein-restricted diet

Observational study: Supplemented protein-restricted diet

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksander Y. Zemchenkov, MD

Role: PRINCIPAL_INVESTIGATOR

St. Petersburg State Budgetary Healthcare Institution "Mariinskaya City Hospital",

Locations

Moscow, , Russia

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

Keto-027-CNI

Identifier Type: -

Identifier Source: org_study_id