Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT06006689 - Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis) Phase 2
Enrolling by invitation NCT05530356 - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed NCT05086549 - An Observation Study to Evaluate the Renoprotective Effect of Fimasartan in Patients With DKD and Proteinuria
Recruiting NCT05008276 - Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
Completed NCT02276196 - Effect of LIXIsenatide on the Renal System Phase 4
Not yet recruiting NCT06120569 - Evaluate the Role of Soleus Muscle Exercise in Glycaemic Control in Diabetic Kidney Disease Patients N/A
Completed NCT02545049 - Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease Phase 3
Active, not recruiting NCT02237352 - Mechanisms of Diabetic Nephropathy in Ecuador
Active, not recruiting NCT06176599 - Clinical Study on the Treatment of Diabetic Kidney Disease With Shenxiao Yuning Decoction With Syndrome of Qi and Yin Deficiency and Blood Stasis N/A
Recruiting NCT03716401 - Prognostic Imaging Biomarkers for Diabetic Kidney Disease
Terminated NCT03840343 - Patient-Derived Stem Cell Therapy for Diabetic Kidney Disease Phase 1
Completed NCT01377688 - Personalized Diabetic Kidney Disease Risk Info to Initiate and Maintain Health Behavior Changes N/A
Active, not recruiting NCT05514548 - Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease Phase 2
Recruiting NCT05507892 - Renal Mechanism of SGLT2 Inhibition Phase 2
Not yet recruiting NCT06049550 - The Influence of the Thickening of Bowman's Capsule on the Clinical Prognosis of Patients With Diabetic Kidney Disease
Not yet recruiting NCT05514184 - Plant-Focused Nutrition in Patients With Diabetes and Chronic Kidney Disease N/A
Active, not recruiting NCT04589351 - Kidney Fat in Type 2 Diabetes and the Effects of Ezetimibe Phase 3
Active, not recruiting NCT04531163 - Possible Ameliorating Effect of N- Acetylcysteine (NAC) on Type-II Diabetes Induced Nephropathy Phase 2/Phase 3
Active, not recruiting NCT03620773 - Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes Phase 1/Phase 2
Suspended NCT01878045 - Mechanisms of Diabetic Kidney Disease in American Indians