NCT03619564

Brief Summary

The purpose of this study is to determine the effect of a ketoanalogue supplemented very low protein diet on eGFR decline in chronic kidney disease compared to a low protein diet (0.6 g/kg, LPD) or no protein restriction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2021

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

3.2 years

First QC Date

July 24, 2018

Last Update Submit

February 21, 2024

Conditions

Chronic Kidney Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Primary composite endpoint: 50 % eGFR decline or renal replacement therapy [Time Frame: From inclusion to 2 years follow up]

    Primary composite endpoint \[Time Frame: From inclusion/Patient enrolment to 2 years follow up\]. Need for renal replacement therapy or an at least 50% reduction in the estimated glomerular filtration rate (eGFR) compared to time of patient inclusion into the study and after 2 years

    2 years

Secondary Outcomes (2)

  • Prescribed diet

    2 years

  • Impact of compliance to prescribed protein diet on the eGRF decline

    2 years

Study Arms (3)

No protein restriction

No protein restriction

Low protein diet (LPD)

LPD: \< 0.8 g/kg bodyweight

Ketoanalogue suppl. very LPD

sVLPD: 0.3-0.4 g/kg bodyweight + keotanalogues

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary nephrologic care

You may qualify if:

  • Age \>=20 years
  • Diagnosis of chronic kidney disease stage 3b to 5 (non-dialysis) according to KDIGO1, i.e. GFR \< 45 ml/min/1.73 m².
  • Regular dietetic consultancy (at least once a year) for patients with stages 4 and 5 (GFR \< 30 ml/min/1.73m²) who are following a LPD or sVLPD.
  • Written informed consent according to local regulations

You may not qualify if:

  • Disturbed amino acid metabolism, e.g. phenylketonuria
  • A kidney transplant
  • Sustained high blood pressure (inadequately controlled (\>160 mmHg systolic or \>110 mmHg diastolic) despite ≥3 antihypertensive medications)
  • Independent life-threatening disease(s), i.e. terminal cancer, AIDS, stage IV heart failure, end stage liver cirrhosis
  • Renal insufficiency caused by
  • Renal cancer
  • Genetic renal diseases, e.g. polycystic kidney disease, congenital nephrotic syndrome
  • Hypersensitivity to the active substances or to any of the excipients of the ketoanalogue supplement
  • Furthermore, pregnant and breast-feeding patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hualien Tzu Chi Hospital

Hualien City, Hualien County, 970, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Kaohsiung County, 833, Taiwan

Location

Keelung Chang Gung Memorial Hospital

Keelung, Keeluing City, 204;, Taiwan

Location

Taipei Tzu Chi Hospital

Taipei, New Taipei City, 231, Taiwan

Location

Shuang Ho Hospital

Taipei, New Taipei City, 235, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taichung City, 407, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Tainan County, 704, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taipei City, 112, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

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

  • Hrishikesh Kulkarni, Dr.

    Fresenius Kabi

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 8, 2018

Study Start

August 1, 2018

Primary Completion

September 28, 2021

Study Completion

September 28, 2021

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(9)