Trials Sponsors Conditions Drugs Pricing

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

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

Sponsors & Collaborators

Fresenius Kabi
Industrylead

Study Sites (9)

Hualien Tzu Chi Hospital

Hualien City, Hualien County, 970, Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Kaohsiung County, 833, Taiwan

Keelung Chang Gung Memorial Hospital

Keelung, Keeluing City, 204;, Taiwan

Taipei Tzu Chi Hospital

Taipei, New Taipei City, 231, Taiwan

Shuang Ho Hospital

Taipei, New Taipei City, 235, Taiwan

Taichung Veterans General Hospital

Taichung, Taichung City, 407, Taiwan

National Cheng Kung University Hospital

Tainan, Tainan County, 704, Taiwan

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

Enrollment

1,000 participants (actual enrollment reported by the registry).

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

Actual (reported)

Chronic Kidney Disease Observational Database - Taiwan

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

No protein restriction

Low protein diet (LPD)

Ketoanalogue suppl. very LPD

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

No protein restriction

Low protein diet (LPD)

Ketoanalogue suppl. very LPD

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations