NCT02746133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 25, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

2.4 years

First QC Date

April 6, 2016

Last Update Submit

January 31, 2019

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (45)

  • Patient compliance to diet (protein and energy intake; investigator and patient-reported, based on patient diary and a routine 3-day food diary)

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

  • CKD stage (according to KDIGO guideline)

    At baseline and 3, 6, 9 and 12 months after enrolment

  • Presence of comorbidities

    At baseline

  • 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

  • +40 more secondary outcomes

Study Arms (1)

Chronic kidney disease (pre-dialysis)

Observational study: Supplemented protein-restricted diet

Other: Observational study: Supplemented protein-restricted diet

Interventions

Observational study: Supplemented protein-restricted dietOTHER

Observational study: Supplemented protein-restricted diet

Chronic kidney disease (pre-dialysis)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Aleksander Y. Zemchenkov, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2016

First Posted

April 21, 2016

Study Start

July 25, 2016

Primary Completion

December 28, 2018

Study Completion

January 14, 2019

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

RU(2)