Diabetic Kidney DiseaseNCT06049550
The Influence of the Thickening of Bowman's Capsule on the Clinical Prognosis of Patients With Diabetic Kidney Disease
An observational study of Diabetic Kidney Disease and Extracellular Matrix Alteration, run by RenJi Hospital.
Trial summary
Diabetic kidney disease (DKD) is the leading cause for renal replacement therapy in developed country. DKD is also the primary cause of ESKD among middle-aged and elderly people in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease, Extracellular Matrix Alteration
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosised as diabetic kidney disease by renal biopsy from January 1, 2017 to December 31, 2021 in Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, the First Affiliated Hospital of China Medical University, Shanghai Sixth People's Hospital and Shanghai General Hospital.
Who may be able to join
- 1) Age ≥ 18 years old, male or female 2) Patients diagnosed as diabetes kidney disease by renal biopsy
Who cannot join
- 1) Patients combined with non diabetes kidney disease; 2) Patients with kidney transplant failure; 3) Patients undergoing zero point puncture for kidney transplantation; 4) less than 5 glomeruli in the renal puncture sample.
Trial locations and contacts
No sites are listed yet.
About this study
Diabetic kidney disease (DKD) is the leading cause for renal replacement therapy in developed country. DKD is also the primary cause of ESKD among middle-aged and elderly people in China. Renal pathological markers have been proved to have clinical and prognostic value in both non diabetic and diabetic kidney diseases. To discriminate lesions by various degrees of severity, the Working Group of the Renal Pathology Society (RPS) developed a pathologic classification for DKD in 2010. The classification is based on glomerular lesions, with a separate evaluation for interstitial and vascular lesions. In a decade, there were several new characteristics common to DKD, such as the presence of mesangiolysis, glomerular hyalinosis, segmental sclerosis and extracapillary hypercellularity, which have been noted in patients with diabetes and may have prognostic importance. But it is still unclear whether thickening of Bowman's capsule predicts the progression of DKD.
- Being tested
- no intervention
- Keywords
- Diabetic Kidney Disease, extracellular matrix, parietal epithelial cells
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| mild thicknening of Bowman's Capsule | Not described Receives: Other: no intervention | |
| severe thickening of Bowman's Capsule | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal failure
estimated glomerular filtration rate（eGFR）<15ml/min/1.73m2, renal replacement treatment or death caused by renal disease
Measured: From the diagnosis of diabetes kidney disease by renal biopsy to December 31, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049550
- Sponsor's protocol ID
- IIT-2023-0174
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Thickening of Bowman's Capsule on the Clinical Prognosis of Patients With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT06049550
- Acronym / sponsor ID
- IIT-2023-0174
- Keywords
- Diabetic Kidney Disease, extracellular matrix, parietal epithelial cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 22 Sep 2023 (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.
Diabetic kidney disease (DKD) is the leading cause for renal replacement therapy in developed country. DKD is also the primary cause of ESKD among middle-aged and elderly people in China. Renal pathological markers have been proved to have clinical and prognostic value in both non diabetic and diabetic kidney diseases. To discriminate lesions by various degrees of severity, the Working Group of the Renal Pathology Society (RPS) developed a pathologic classification for DKD in 2010. The classification is based on glomerular lesions, with a separate evaluation for interstitial and vascular lesions. In a decade, there were several new characteristics common to DKD, such as the presence of mesangiolysis, glomerular hyalinosis, segmental sclerosis and extracapillary hypercellularity, which have been noted in patients with diabetes and may have prognostic importance. But it is still unclear whether thickening of Bowman's capsule predicts the progression of DKD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild thicknening of Bowman's Capsule | – | Other: no intervention |
| severe thickening of Bowman's Capsule | – | Other: no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosised as diabetic kidney disease by renal biopsy from January 1, 2017 to December 31, 2021 in Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, the First Affiliated Hospital of China Medical University, Shanghai Sixth People's Hospital and Shanghai General Hospital.
Key inclusion criteria (1 listed)
- 1) Age ≥ 18 years old, male or female 2) Patients diagnosed as diabetes kidney disease by renal biopsy
Key exclusion criteria (1 listed)
- 1) Patients combined with non diabetes kidney disease; 2) Patients with kidney transplant failure; 3) Patients undergoing zero point puncture for kidney transplantation; 4) less than 5 glomeruli in the renal puncture sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | mild thicknening of Bowman's Capsule, severe thickening of Bowman's Capsule |
Primary outcome
renal failure
Time frame: From the diagnosis of diabetes kidney disease by renal biopsy to December 31, 2022
estimated glomerular filtration rate（eGFR）<15ml/min/1.73m2, renal replacement treatment or death caused by renal disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease and Extracellular Matrix Alteration, run by RenJi Hospital.
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 22 Sep 2023. 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?
Contact Jiayue Lu (86-21-34506332, royalkeane@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal failure (time frame: From the diagnosis of diabetes kidney disease by renal biopsy to December 31, 2022). 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 22 Sep 2023.