Chronic Kidney DiseaseNCT01250626
Establish the Caring Model of Children With Chronic Kidney Disease and End-stage Renal Disease: To Set up Childhood Glomerular Filtration Rate (GFR) Formula in Taiwan
An observational study of Chronic Kidney Disease and End-Stage Renal Disease, run by China Medical University Hospital.
Trial summary
Inulin's usefulness as a diagnostic agent is based on the method of its elimination from the body. Inulin is biologically inert, unbound by plasma proteins, freely filtered at the glomerulus, and is neither reabsorbed, metabolized nor secreted by the kidneys. It is excreted almost entirely by glomerular filtration. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Chronic Kidney Disease, End-Stage Renal Disease
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric OPD, age < 18 y/o.
- Main inclusion criteria: Pediatric OPD, age < 18 y/o.
- Main exclusion criteria: Acute renal failure, edema, muscular dystrophy, pleural effusion, ascites, malnutrition, neurogenic bladder, heart failure and ketoacidosis. And taken cimetidine or trimethoprim, and accepted renal replacement therapy.
About this study
Inulin's usefulness as a diagnostic agent is based on the method of its elimination from the body. Inulin is biologically inert, unbound by plasma proteins, freely filtered at the glomerulus, and is neither reabsorbed, metabolized nor secreted by the kidneys. It is excreted almost entirely by glomerular filtration. Inulin clearance is considered to be identical to glomerular filtration rate (GFR).
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease
- Keywords
- Inulin, childhood GFR formula
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| a single-group study | Pediatric OPD, age < 18 y/o. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250626
- Sponsor's protocol ID
- DMR99-IRB-139
- Status last verified
- Aug 2010
- First submitted
- 29 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish the Caring Model of Children With Chronic Kidney Disease and End-stage Renal Disease: To Set up Childhood Glomerular Filtration Rate (GFR) Formula in Taiwan
- ClinicalTrials.gov ID
- NCT01250626
- Acronym / sponsor ID
- DMR99-IRB-139
- Conditions
- Chronic Kidney Disease, End-Stage Renal Disease
- Keywords
- Inulin, childhood GFR formula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- Aug 2010
- First posted
- 1 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inulin's usefulness as a diagnostic agent is based on the method of its elimination from the body. Inulin is biologically inert, unbound by plasma proteins, freely filtered at the glomerulus, and is neither reabsorbed, metabolized nor secreted by the kidneys. It is excreted almost entirely by glomerular filtration. Inulin clearance is considered to be identical to glomerular filtration rate (GFR).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a single-group study | – | –Pediatric OPD, age < 18 y/o. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric OPD, age < 18 y/o.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and End-Stage Renal Disease, run by China Medical University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2010.