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

Diabetic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06049550
• Other study ID #: IIT-2023-0174
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: September 2023
• Source: RenJi Hospital
• Contact: Jiayue Lu
• Phone: 86-21-34506332
• Email: royalkeane[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: October 31, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Extracellular Matrix Alteration
• Kidney Diseases

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal failure	estimated glomerular filtration rate(eGFR)<15ml/min/1.73m2, renal replacement treatment or death caused by renal disease	From the diagnosis of diabetes kidney disease by renal biopsy to December 31, 2022