Renal Fibrosis, CKDNCT05012228
Molecular Mechanisms of Fibrillin/LTBP Superfamily in Renal Fibrosis and Cardiorenal Syndrome
An observational study of Renal Fibrosis, CKD, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This project is to understand the LTBP4 expression in human renal fibrotic tissues. The investigators will exam major location of LTBP4 expression and check any similar or discrepancy in renal fibrosis with different etiologies. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Fibrosis, CKD
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2021to 31 Dec 2024
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with chronic kidney disease, which has remaining specimens in NTUH. The investigators want to use 2008-2016 specimens in Department of Pathology, NTUH.
Who may be able to join
- Abnormal kidney function, proteinuria, hematuria
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chi-Ting Su, MD. MPH. PhD
About this study
Official title: Molecular Mechanisms of Fibrillin/LTBP Superfamily in Renal Fibrosis and Cardiorenal
This project is to understand the LTBP4 expression in human renal fibrotic tissues. The investigators will exam major location of LTBP4 expression and check any similar or discrepancy in renal fibrosis with different etiologies.
Read the detailed description
The investigators will obtain the residual renal tissues with different etiologies and check the expression of LTBP4. The location and quantitation of LTBP4 in renal tissues will be checked. It will be great to understand the association between the severity of fibrosis and the expression of LTBP4 and other matrix proteins.
- Conditions
- Renal Fibrosis, CKD
- Keywords
- LTBP4
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of LTBP4 in human renal fibrotic tissue
Measured: 5 years
Expression of biomarkers in human renal fibrotic tissue
Potential markers: eg. ROS-related proteins (8-oxodG, 4-HNE)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start1 Jul 2021
- Primary completion1 Mar 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Fibrosis, CKDStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05012228
- Sponsor's protocol ID
- 202101074RINC
- Status last verified
- Apr 2024
- First submitted
- 3 Aug 2021
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Mechanisms of Fibrillin/LTBP Superfamily in Renal Fibrosis and Cardiorenal
- ClinicalTrials.gov ID
- NCT05012228
- Acronym / sponsor ID
- 202101074RINC
- Conditions
- Renal Fibrosis, CKD
- Keywords
- LTBP4
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Aug 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 project is to understand the LTBP4 expression in human renal fibrotic tissues. The investigators will exam major location of LTBP4 expression and check any similar or discrepancy in renal fibrosis with different etiologies.
Detailed description
The investigators will obtain the residual renal tissues with different etiologies and check the expression of LTBP4. The location and quantitation of LTBP4 in renal tissues will be checked. It will be great to understand the association between the severity of fibrosis and the expression of LTBP4 and other matrix proteins.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with chronic kidney disease, which has remaining specimens in NTUH. The investigators want to use 2008-2016 specimens in Department of Pathology, NTUH.
Key inclusion criteria (1 listed)
- Abnormal kidney function, proteinuria, hematuria
Key exclusion criteria (1 listed)
- N/A
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
Expression of LTBP4 in human renal fibrotic tissue
Time frame: 5 years
Expression of biomarkers in human renal fibrotic tissue
Time frame: 5 years
Potential markers: eg. ROS-related proteins (8-oxodG, 4-HNE)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Renal Fibrosis, CKD
RecruitingObservational study
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Gastric Antral Vascular Ectasia, Cirrhosis
Enrolling by invitation
FAP-targeting PET/CT for Noninvasive Monitoring of Renal Fibrosis
CKD, Renal Fibrosis
Not yet recruiting
Finerenone for AKI: a Multicenter, Randomized, Placebo-Controlled Feasibility Pilot Trial
Acute Kidney Injury, Renal Insufficiency,Chronic
Recruiting
Evaluation of Kidney Fibrosis Via FAPI PET/CT
Chronic Kidney Disease
RecruitingObservational study
Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiometabolic, and Musculoskeletal Disorder Research (VALD)
Obesity and Obesity-related Medical Conditions, Diabetes
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 Renal Fibrosis, CKD, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 17 Apr 2024. 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 Taiwan. 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?
Contact Chi-Ting Su, MD, MPH, PhD (+88697262878, A01218@ntucc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of LTBP4 in human renal fibrotic tissue (time frame: 5 years). The study lists 2 primary outcomes in all. 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 17 Apr 2024.