Diabetic Kidney DiseaseNCT03865914
Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy
An observational study of Diabetic Kidney Disease, run by Chinese PLA General Hospital at 1 site in China.
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）. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2017to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The aim of this study is 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Xiangmei Chen, MD.&Ph.D, +86 010 66935462, xmchen301@126.com
Qian Wang, MM, +86 010 66935462, 794317255@qq.com
About this study
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.
- Conditions
- Diabetic Kidney Disease
- Keywords
- Diabetic kidney disease (DKD), Diabetic nephropathy（DN), non-diabetic renal diseases（ NDRD), Clinical-pathological correlations, differential diagnosis
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetic nephropathy | The cohort will be followed for at least 10 years. The cohort will be divided into 2 groups according the pathological results of patients,and at least 3 groups according to clinical features such as renal function and proteinuria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in eGFR and urine protein from baseline
eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine.
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start30 Nov 2017
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission, China-Japan Friendship Hospital, Beijing Friendship Hospital, Beijing Hospital, Fourth Medical Center of PLA General Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Third Medical Center of Chinese PLA General Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, The First Affiliated Hospital of Dalian Medical University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Dongzhimen Hospital, Beijing, Shanghai University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Xiangmei Chen, Chinese PLA General Hospital
- Investigators
- Xiangmei Chen, MD.&Ph.D, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865914
- Sponsor's protocol ID
- S2017-133-01
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The test has not been completed.
Publications
Wang Q, Zhou S, Niu Y, Li C, Lyu Q, Chen P, Zhang X, Xie L, Shen W, Wang Y, Cao X, Cai G, Chen X, Wang H, Dong Z. Clinical utility of BOLD-MRI in accurate diagnosis and prognostic evaluation of diabetic nephropathy: a prospective renal biopsy-based cohort study. Insights Imaging. 2026 Apr 20;17(1):106. doi: 10.1186/s13244-026-02274-9.
PubMed 42008071Dong Z, Wang X, Pan S, Weng T, Chen X, Jiang S, Li Y, Wang Z, Cao X, Wang Q, Chen P, Jiang L, Cai G, Zhang L, Wang Y, Yang J, He Y, Lin H, Wu J, Tang L, Zhou J, Li S, Li Z, Fu Y, Yu X, Geng Y, Zhang Y, Wang L, Xu M, Chen X. A multimodal transformer system for noninvasive diabetic nephropathy diagnosis via retinal imaging. NPJ Digit Med. 2025 Jan 24;8(1):50. doi: 10.1038/s41746-024-01393-1.
PubMed 39856403Wang Q, Cheng H, Jiang S, Zhang L, Liu X, Chen P, Liu J, Li Y, Liu X, Wang L, Li Z, Cai G, Chen X, Dong Z. The relationship between diabetic retinopathy and diabetic nephropathy in type 2 diabetes. Front Endocrinol (Lausanne). 2024 Jan 26;15:1292412. doi: 10.3389/fendo.2024.1292412. eCollection 2024.
PubMed 38344659Zhang W, Liu X, Dong Z, Wang Q, Pei Z, Chen Y, Zheng Y, Wang Y, Chen P, Feng Z, Sun X, Cai G, Chen X. New Diagnostic Model for the Differentiation of Diabetic Nephropathy From Non-Diabetic Nephropathy in Chinese Patients. Front Endocrinol (Lausanne). 2022 Jun 30;13:913021. doi: 10.3389/fendo.2022.913021. eCollection 2022.
PubMed 35846333Qu YL, Dong ZY, Cheng HM, Liu Q, Wang Q, Yang HT, Mao YH, Li JJ, Liu HF, Geng YQ, Huang W, Liu WH, Xie HD, Peng F, Li S, Jiang SS, Li WZ, Duan SW, Feng Z, Zhang WG, Liu YN, Tian JZ, Chen XM. Evaluation of Renal Impairment in Patients with Diabetic Kidney Disease by Integrated Chinese and Western Medicine. Chin J Integr Med. 2023 Apr;29(4):308-315. doi: 10.1007/s11655-022-3520-0. Epub 2022 Jun 9.
PubMed 35679002
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Study Between Clinical Phenotype and Pathology of Type 2 Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT03865914
- Acronym / sponsor ID
- S2017-133-01
- Conditions
- Diabetic Kidney Disease
- Keywords
- Diabetic kidney disease (DKD), Diabetic nephropathy（DN), non-diabetic renal diseases（ NDRD), Clinical-pathological correlations, differential diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission, China-Japan Friendship Hospital, Beijing Friendship Hospital, Beijing Hospital, Fourth Medical Center of PLA General Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Third Medical Center of Chinese PLA General Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, The First Affiliated Hospital of Dalian Medical University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Dongzhimen Hospital, Beijing, Shanghai University of Traditional Chinese Medicine
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 Mar 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic nephropathy | – | –The cohort will be followed for at least 10 years. The cohort will be divided into 2 groups according the pathological results of patients,and at least 3 groups according to clinical features such as renal function and proteinuria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The aim of this study is 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in eGFR and urine protein from baseline
Time frame: 24months
eGFR is calculated using the CKD-EPI formula, involving gender, age, and serum creatinine.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 42008071Wang Q, Zhou S, Niu Y, Li C, Lyu Q, Chen P, Zhang X, Xie L, Shen W, Wang Y, Cao X, Cai G, Chen X, Wang H, Dong Z. Clinical utility of BOLD-MRI in accurate diagnosis and prognostic evaluation of diabetic nephropathy: a prospective renal biopsy-based cohort study. Insights Imaging. 2026 Apr 20;17(1):106. doi: 10.1186/s13244-026-02274-9.
- Derived from this study: PubMed 39856403Dong Z, Wang X, Pan S, Weng T, Chen X, Jiang S, Li Y, Wang Z, Cao X, Wang Q, Chen P, Jiang L, Cai G, Zhang L, Wang Y, Yang J, He Y, Lin H, Wu J, Tang L, Zhou J, Li S, Li Z, Fu Y, Yu X, Geng Y, Zhang Y, Wang L, Xu M, Chen X. A multimodal transformer system for noninvasive diabetic nephropathy diagnosis via retinal imaging. NPJ Digit Med. 2025 Jan 24;8(1):50. doi: 10.1038/s41746-024-01393-1.
- Derived from this study: PubMed 38344659Wang Q, Cheng H, Jiang S, Zhang L, Liu X, Chen P, Liu J, Li Y, Liu X, Wang L, Li Z, Cai G, Chen X, Dong Z. The relationship between diabetic retinopathy and diabetic nephropathy in type 2 diabetes. Front Endocrinol (Lausanne). 2024 Jan 26;15:1292412. doi: 10.3389/fendo.2024.1292412. eCollection 2024.
- Derived from this study: PubMed 35846333Zhang W, Liu X, Dong Z, Wang Q, Pei Z, Chen Y, Zheng Y, Wang Y, Chen P, Feng Z, Sun X, Cai G, Chen X. New Diagnostic Model for the Differentiation of Diabetic Nephropathy From Non-Diabetic Nephropathy in Chinese Patients. Front Endocrinol (Lausanne). 2022 Jun 30;13:913021. doi: 10.3389/fendo.2022.913021. eCollection 2022.
- Derived from this study: PubMed 35679002Qu YL, Dong ZY, Cheng HM, Liu Q, Wang Q, Yang HT, Mao YH, Li JJ, Liu HF, Geng YQ, Huang W, Liu WH, Xie HD, Peng F, Li S, Jiang SS, Li WZ, Duan SW, Feng Z, Zhang WG, Liu YN, Tian JZ, Chen XM. Evaluation of Renal Impairment in Patients with Diabetic Kidney Disease by Integrated Chinese and Western Medicine. Chin J Integr Med. 2023 Apr;29(4):308-315. doi: 10.1007/s11655-022-3520-0. Epub 2022 Jun 9.
- Individual participant dataSharing planned: No. The test has not been completed.
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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.
Xiangmei Chen, MD.&Ph.D principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease, run by Chinese PLA General Hospital at 1 site in China.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangmei Chen, MD.&Ph.D (+86 010 66935462, xmchen301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in eGFR and urine protein from baseline (time frame: 24months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03865914, which also lists 5 linked publications.
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 31 Mar 2022.