The Influence of the Thickening of Bowman's Capsule on the Clinical Prognosis of Patients With Diabetic Kidney Disease

• Sponsor: RenJi Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06049550
• Collaborator: (none)
• Enrollment: 250
• Anticipated Duration (Days): 30

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Kidney Disease; Extracellular Matrix Alteration	Other: no intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 250 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: The Influence of the Thickening of Bowman's Capsule on the Clinical Prognosis of Patients With Diabetic Kidney Disease
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
mild thicknening of Bowman's Capsule	Other: no intervention; no intervention
severe thickening of Bowman's Capsule	Other: no intervention; no intervention

Outcome Measures

Primary Outcome Measures

1. renal failure [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1. Age ≥ 18 years old, male or female 2) Patients diagnosed as diabetes kidney disease by renal biopsy

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• RenJi Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RenJi Hospital
• ClinicalTrials.gov Identifier: NCT06049550
• Other Study ID Numbers: IIT-2023-0174
• First Posted: Sep 22, 2023
• Last Update Posted: Sep 22, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by RenJi Hospital: Diabetic Kidney Disease; extracellular matrix; parietal epithelial cells
• Additional relevant MeSH terms: Kidney Diseases; Diabetic Nephropathies

Study Results

No Results Posted as of Sep 22, 2023