Chronic Kidney Disease Observational Database - Taiwan (CKDOD)

February 21, 2024 updated by: Fresenius Kabi
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.

Study Overview

Status

Completed

Detailed Description

An important part of care in chronic kidney disease is an adapted diet. Its most important aspect is protein restriction. The rationale for protein restriction is a reduction of uremic wastes. However, nutritional requirements for protein synthesis limit the maximum extent of protein restriction. To deal with these conflicting targets, a minimum protein intake supplemented with ketoanalogues of amino acids (supplemented very low protein diet, sVLPD) meets the protein needs while reducing uremic waste.

The aim of this explorative, observational study is to determine the effect of sVLPD on eGFR decline compared to a low protein diet (LPD) or no protein restriction.

Data collection The study uses only data from routine health care records. The transfer to the electronic case report form is done by center investigators.

Data entry is monitored monthly for completeness and plausibility. Missing or unusual data will be requested for completion or re-assessment.

In case of high loss to follow up (>10%), low follow up frequency (<90% of patients with <3 visits per year), or greater than 5% missing core data (age, gender, descent, height, weight, history of diabetes and hypertension, blood pressure, serum creatinin, dietary prescription, judgement of compliance), audit visits including source data verification and trainings may be done.

Primary analysis Direct comparison of patients receiving sVLPD or LPD is not meaningful due to the non-interventional design. It is expected that sVLPD patients will have a more advanced stage of CKD, most likely will have higher severity of disease and possibly may have different demographic baseline data. Furthermore, other well-known risk factors for progression of chronic kidney disease like the presence of diabetes mellitus or high blood pressure may affect eGFR decline.

A relevant amount of data is expected to be missing due to the observational nature and the use of data from clinical routine. Furthermore, missing data are unlikely to occur completely at random.

Therefore, missing data will not be imputed but they will be implicitly modeled by a mixed model: mean changes of eGFR from baseline will be analyzed using a restricted maximum-likelihood based repeated measures approach. Analyses will include the fixed, categorical effects of actual treatment, study center, gender, visit time, and baseline variables presence of smoking history, diabetes mellitus, hypertension, and baseline eGFR. Patient will be included as a random factor to the model. Significance tests will use a two-sided α = 0.05.

Secondary analyses Compliance, dietary counselling, use of a nutritional diary, primary diagnosis of CKD, diabetes mellitus, and vegetarian diet will be included to the model described before and analyzed for independent effects or effect modification of the diet.

The approach to the secondary analysis of development of serum urea is similar to the primary analysis.

Cox-regression analysis will be done for time to dialysis initiation or reaching the composite endpoint [>50% eGFR decline or initiation of maintenance dialysis treatment] including the same baseline variables as mentioned for the primary endpoint.

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taoyuan, Taiwan, 333
        • Linkou Chang Gung Memorial Hospital
    • Hualien County
      • Hualien City, Hualien County, Taiwan, 970
        • Hualien Tzu Chi Hospital
    • Kaohsiung County
      • Kaohsiung, Kaohsiung County, Taiwan, 833
        • Kaohsiung Chang Gung Memorial Hospital
    • Keeluing City
      • Keelung, Keeluing City, Taiwan, 204;
        • Keelung Chang Gung Memorial Hospital
    • New Taipei City
      • Taipei, New Taipei City, Taiwan, 231
        • Taipei Tzu Chi Hospital
      • Taipei, New Taipei City, Taiwan, 235
        • Shuang Ho Hospital
    • Taichung City
      • Taichung, Taichung City, Taiwan, 407
        • Taichung Veterans General Hospital
    • Tainan County
      • Tainan, Tainan County, Taiwan, 704
        • National Cheng Kung University Hospital
    • Taipei City
      • Taipe, Taipei City, Taiwan, 112
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary nephrologic care

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:Hypercalcemia

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure
Measure Description
Time Frame
Prescribed diet
Time Frame: 2 years
Prescribed diet (no protein restriction, low protein diet, supplemented very low protein diet), 2 years
2 years
Impact of compliance to prescribed protein diet on the eGRF decline
Time Frame: 2 years
Dietary compliance, 2 years, assessed by consulted dietitian (if available) estimating rated from 0 (not compliant) to 4 (fully compliant); 24 hours urine (if available, urinary urea excretion to assess the actual protein intake in comparison with the prescribed diet [normal diet, LPD, sVLPD)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Hrishikesh Kulkarni, Dr., Fresenius Kabi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

September 28, 2021

Study Completion (Actual)

September 28, 2021

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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