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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03865914
Other study ID # S2017-133-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 30, 2017
Est. completion date December 31, 2030

Study information

Verified date March 2022
Source Chinese PLA General Hospital
Contact Xiangmei Chen, MD.&Ph.D
Phone +86 010 66935462
Email xmchen301@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

With the rapid increase of diabetic nephropathy worldwide, type 2 diabetes mellitus(DM) is the leading cause of end-stage renal disease(ESRD). Pathological types of diabetic kidney disease(DKD) could be mainly divided into diabetic nephropathy(DN)and non-diabetic renal diseases(NDRD). There are no accurate renal biopsy indications and standardized operation procedures for type 2 diabetic nephropathy. The clinical stages of type 2 diabetic nephropathy still referred to the Mogensen stage of type 1 diabetic nephropathy. Thus, our study aim to clarify the differences in clinical phenotype between type 2 DN and type 2 NDRD, analysis the correlation between clinical and pathological features, and offer the criteria for clinical staging and prognosis.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 31, 2030
Est. primary completion date November 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age=18, male or female - Clinical diagnosed as type 2 diabetes mellitus - The presence of renal impairment including: microalbuminuria or overt proteinuria or renal insufficiency - The renal biopsy was performed with complete renal pathological diagnosis - Obtaining the signed informed consent from patients Exclusion Criteria: - The history of the disease was not complete - Clinical diagnosed as other secondary renal diseases - Patients with hereditary kidney disease - Autoimmune diseases - Patients with malignant tumor were expected to survive less than 6 months - Pregnancy and lactation

Study Design


Locations

Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (15)

Lead Sponsor Collaborator
Chinese PLA General Hospital Beijing Friendship Hospital, Beijing Hospital, Beijing Municipal Science & Technology Commission, China-Japan Friendship Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Dongzhimen Hospital, Beijing University of Chinese Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Fourth Medical Center of PLA General Hospital, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai University of Traditional Chinese Medicine, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Dalian Medical University, Third Medical Center of PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in eGFR and urine protein from baseline eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine. 24months
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