ElderNCT05158959
Association Between Renal Reserve Function and Progression of Renal Function to Predict CKD Risk in Thai Elderly
An observational study of Elder and Renal Function Abnormal, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study investigates renal functional reserve in elderly. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elder, Renal Function Abnormal
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 24 Oct 2019to 30 Dec 2022
- How long will I take part?
- 12 Months
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elders age more than 60 years who are non-frail and has no limited life expectancy
Who may be able to join
- Patient age > 60 years at screening
- Patient willing to participate in the study and can provide inform consent
- Patient have residual kidney function ≤ 90 ml/min/1.73m2 by CKD-EPI equation
Who cannot join
- Patient active smoking
- Patient have Charlson comorbidity index > .....
- Patient active cancer
- Patient contraindications for blood collection
- Patients with a history of hypersensitivity to cimetidine or amino acid IV solution
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Kearkiat Praditpornsilpa
Bangkok, 10330
Kearkiat Praditpornsilpa, MD, 6602564251, kearkiat@hotmail.com
About this study
Official title: Study of the Association Between Renal Reserve Function and Progression of Renal Function to Predict Chronic Kidney Disease Risk in Thai Elderly
This study investigates renal functional reserve in elderly.
Read the detailed description
The prevalence of CKD in elder is high as age has been a variable in eGFR equation. eGFR by calculation always declines in parallel with age. The assumption that a persistent over 3 months of eGFR less than 60 mL/min/1.73m2 define CKD with risk of progression and need refer to nephrologist may not necessary true in aging population. We study renal functional reserve in elderly population who risk of CKD progression and ESRD is the highest prevalence in human life cycle and explore whether renal functional reserve can be used as ad additional marker of CKD progression in elderly.
- Conditions
- Elder, Renal Function Abnormal
- Keywords
- Renal functional reserve, CKD progression, Elderly
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of renal functional reserve per 12 months (mL/min)
Renal functional reserve defined as the difference between baseline creatinine clearance and creatinine clearance achieved under stimulation with amino acid infusion.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start24 Oct 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kearkiat Praditpornsilpa, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158959
- Sponsor's protocol ID
- IRB NO.527/62
- Status last verified
- Sep 2021
- First submitted
- 2 Dec 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Association Between Renal Reserve Function and Progression of Renal Function to Predict Chronic Kidney Disease Risk in Thai Elderly
- ClinicalTrials.gov ID
- NCT05158959
- Acronym / sponsor ID
- IRB NO.527/62
- Conditions
- Elder, Renal Function Abnormal
- Keywords
- Renal functional reserve, CKD progression, Elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 15 Dec 2021 (actual)
- 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.
This study investigates renal functional reserve in elderly.
Detailed description
The prevalence of CKD in elder is high as age has been a variable in eGFR equation. eGFR by calculation always declines in parallel with age. The assumption that a persistent over 3 months of eGFR less than 60 mL/min/1.73m2 define CKD with risk of progression and need refer to nephrologist may not necessary true in aging population. We study renal functional reserve in elderly population who risk of CKD progression and ESRD is the highest prevalence in human life cycle and explore whether renal functional reserve can be used as ad additional marker of CKD progression in elderly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elders age more than 60 years who are non-frail and has no limited life expectancy
Key inclusion criteria (3 listed)
- Patient age > 60 years at screening
- Patient willing to participate in the study and can provide inform consent
- Patient have residual kidney function ≤ 90 ml/min/1.73m2 by CKD-EPI equation
Key exclusion criteria (5 listed)
- Patient active smoking
- Patient have Charlson comorbidity index > .....
- Patient active cancer
- Patient contraindications for blood collection
- Patients with a history of hypersensitivity to cimetidine or amino acid IV solution
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
Change of renal functional reserve per 12 months (mL/min)
Time frame: 12 months
Renal functional reserve defined as the difference between baseline creatinine clearance and creatinine clearance achieved under stimulation with amino acid infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elder and Renal Function Abnormal, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. 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 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of renal functional reserve per 12 months (mL/min) (time frame: 12 months). It is what the study was designed to measure, not a finding.
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 15 Dec 2021.