Diabetic Kidney DiseaseNCT05021705
Non Diabetic Causes of Chronic Kidney Disease in Type 2 Diabetic Patients
An observational study of Diabetic Kidney Disease, run by Assiut University.
Trial summary
Determination of the possible causes of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus with an atypical presentations of renal disease for proper management and thus improving renal outcome. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetic Kidney Disease
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 Diabetic patients
Who may be able to join
- Patients with type 2 diabetes mellitus having proteinuria associated with macroscopic or microscopic haematuria.
- Patients with type 2 diabetes mellitus with nephrotic syndrome appearing in the early stages of DM (less than 10 years of diagnosis) in absence of retinopathy or neuropathy.
- Patients with type 2 diabetes mellitus with unexplained renal failure or rapidly progressive renal dysfunction within few weeks or months.
- Patients with type 2 diabetes mellitus with symptoms and signs suggestive of systemic disease that may affect the kidney as SLE, vasculitis, multiple myeloma or lymphoma.
- Patients with type 2 diabetes mellitus with rapidly progressive glomerulonephritis.
Who cannot join
- Patients with type 1 diabetes mellitus.
- DM with clinically, laboratory or radiologically evident CKD due to either chronic pyelonephritis, polycystic kidney disease or chronic obstructive nephropathy.
- DM with end stage renal disease (ESRD) with bilateral small kidneys.
- Patients with any contraindication to renal biopsy (systemic infections, bleeding tendency, low platelets, decrease prothrombin concentration).
About this study
Determination of the possible causes of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus with an atypical presentations of renal disease for proper management and thus improving renal outcome.
Read the detailed description
Diabetes mellitus (DM) is one of the most important health problems worldwide, and its prevalence is increasing. One of the complications of DM is diabetic kidney disease (DKD), which is responsible for over 40% of cases of chronic kidney disease requiring dialysis or kidney transplantation in the Western world.
The natural history of DKD in patients with type 1 DM is well characterized because we know the precise time of DM onset. Classically, these patients develop microalbuminuria, followed by macroalbuminuria in the first 15 years of DM. After 20 years of DM, progressive loss of glomerular filtration rate (GFR) develops. The majority of these patients have diabetic retinopathy. However, the natural history of renal disease in adults with DM type 2 is controversial. Before diagnosis, type 2 DM has usually evolved over several years but has remained unnoticed.
In 2007, KDOQI guidelines described characteristics of diabetic patients that indicate DKD involvement, namely the presence of macroalbuminuria or microalbuminuria with diabetic retinopathy in both types of DM, and in type 1 DM patients, over 10 years of DM. In addition, the guidelines summarize the characteristics that suggest the presence of non-diabetic kidney disease (NDKD): absence of diabetic retinopathy, fast decline of renal function, fast increase in proteinuria or nephrotic syndrome, refractory hypertension, active urinary sediment or signs or symptoms of systemic disease or>30% reduction in GFR within 2-3 months after starting the blockade of the renin-angiotensin-aldosterone system (RAAS).Yuan 2017 addressed the accuracy of a clinical diagnosis of DKD among diabetic patients following the criteria proposed by the KDOQI guidelines. Around 20% of patients did not meet KDOQI criteria for DKD in type 2 DM, suggesting a significant over estimation of DKD in this population. This high proportion of NDKD matches previous publications which demonstrated that about a third of patients with DM have biopsy-proven NDKD. The gold standard for diagnosis is renal biopsy. Renal biopsy in diabetic patients has focused on identifying NDKD, because these patients have different prognosis and therapy. The most frequent biopsy indications in diabetic patients are nephrotic syndrome, nephrotic proteinuria in patients with < 5 years of DKD evolution, microhaematuria, acute kidney injury and unexplained decline of renal function. Several groups have studied renal biopsies from diabetic patients, showing that the most frequent NDKD diagnoses are IgA nephropathy, membranous nephropathy and focal segmental glomerulosclerosis.
Different studies have shown that patients with DKD have a worse renal prognosis and that the prevalence of NDKD is high in diabetic patients. Therefore, it is important to accurately classify diabetic patients for DKD or NDKD. Yuan 2017 studied the differential characteristics between patients meeting clinical criteria to diagnose DKD according to KDOQI and misclassified patients. They showed that those patients lacking KDOQI-predicted DKD were more likely to have an active urine sediment and less likely to have developed macroalbuminuria or retinopathy prior to end-stage renal disease. Using the logistic regression analysis, diabetic retinopathy was the only factor independently associated with patients who met KDOQI criteria.
Kidney biopsy studies in diabetic patients have found predictive factors for NDKD: absence of diabetic retinopathy, low glycosylated haemoglobin, worse renal function, lower level of proteinuria, the presence of microscopic haematuria, older age and shorter DM evolution. Although the Yuan 2017 cohort is small and the diagnostic method was usually not renal biopsy, the results are in line with prior reports. However, recent studies have shown that patients with biopsy-proven DKD may be normoalbuminuric. Thus, further studies with larger cohorts and ideally renal biopsy confirmation are necessary to find factors better predicting NDKD in type 2 diabetic patients. These studies may help to design novel diagnostic tools to be applied by physicians in daily clinical practice. New therapeutic agents for the treatment of DKD have recently been characterized. Endothelin receptor antagonists, sodium glucose co-transporter2 inhibitors, incretins and agents targeting inflammation/fibrosis are probably the most promising candidates on top of the classical RAAS blockers. Therefore, it is mandatory that patients with diabetic renal disease are adequately classified, differentiating clearly those with DKD and those with NDKD. In addition, among those with DKD, a reliable classification within different pathological categories will be of great value to individualize treatment strategies.
- Conditions
- Diabetic Kidney Disease
- Medical subject headings
- Diabetic Nephropathies
What is being measured
The primary outcome is the main question the study is designed to answer.
renal biopsy
The preferred site for renal biopsy was the lateral aspect of the lower pole of the left kidney under ultrasound guidance with the patient in the prone position and local anesthesia was used. An automated biopsy gun and a 16 gauge needle was used to ensure the biopsy sample contained a minimum of ten glomeruli. After biopsy compression on site of biopsy was done and strict follow up for the patient to exclude any complications. No complications were occurred for any patients. Renal biopsy specimens were prepared according to standard methods for light microscopy and immunoperoxidase. Electron microscopy was not routinely performed.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study startJan 2016
- Primary completionSep 2019
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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 Assiut UniversityThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nady Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021705
- Sponsor's protocol ID
- Non diabetic kidney disease
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Espinel E, Agraz I, Ibernon M, Ramos N, Fort J, Seron D. Renal Biopsy in Type 2 Diabetic Patients. J Clin Med. 2015 May 18;4(5):998-1009. doi: 10.3390/jcm4050998.
PubMed 26239461Kramer A, Pippias M, Noordzij M, Stel VS, Afentakis N, Ambuhl PM, Andrusev AM, Fuster EA, Arribas Monzon FE, Asberg A, Barbullushi M, Bonthuis M, Caskey FJ, Castro de la Nuez P, Cernevskis H, des Grottes JM, Garneata L, Golan E, Hemmelder MH, Ioannou K, Jarraya F, Kolesnyk M, Komissarov K, Lassalle M, Macario F, Mahillo-Duran B, Martin de Francisco AL, Palsson R, Pechter U, Resic H, Rutkowski B, Santiuste de Pablos C, Seyahi N, Simic Ogrizovic S, Slon Roblero MF, Spustova V, Stojceva-Taneva O, Traynor J, Massy ZA, Jager KJ. The European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Registry Annual Report 2015: a summary. Clin Kidney J. 2018 Feb;11(1):108-122. doi: 10.1093/ckj/sfx149. Epub 2018 Jan 5.
PubMed 29423210Lytvyn Y, Bjornstad P, Pun N, Cherney DZ. New and old agents in the management of diabetic nephropathy. Curr Opin Nephrol Hypertens. 2016 May;25(3):232-9. doi: 10.1097/MNH.0000000000000214.
PubMed 26890303Kramer HJ, Nguyen QD, Curhan G, Hsu CY. Renal insufficiency in the absence of albuminuria and retinopathy among adults with type 2 diabetes mellitus. JAMA. 2003 Jun 25;289(24):3273-7. doi: 10.1001/jama.289.24.3273.
PubMed 12824208KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154. doi: 10.1053/j.ajkd.2006.12.005. No abstract available.
PubMed 17276798Yuan CM, Nee R, Ceckowski KA, Knight KR, Abbott KC. Diabetic nephropathy as the cause of end-stage kidney disease reported on the medical evidence form CMS2728 at a single center. Clin Kidney J. 2017 Apr;10(2):257-262. doi: 10.1093/ckj/sfw112. Epub 2016 Dec 22.
PubMed 28396744Bermejo S, Soler MJ, Gimeno J, Barrios C, Rodriguez E, Mojal S, Pascual J. Predictive factors for non-diabetic nephropathy in diabetic patients. The utility of renal biopsy. Nefrologia. 2016 Sep-Oct;36(5):535-544. doi: 10.1016/j.nefro.2016.06.006. Epub 2016 Aug 11. English, Spanish.
PubMed 27523263Fiorentino M, Bolignano D, Tesar V, Pisano A, Van Biesen W, D'Arrigo G, Tripepi G, Gesualdo L; ERA-EDTA Immunonephrology Working Group. Renal Biopsy in 2015--From Epidemiology to Evidence-Based Indications. Am J Nephrol. 2016;43(1):1-19. doi: 10.1159/000444026. Epub 2016 Feb 5.
PubMed 26844777Sharma SG, Bomback AS, Radhakrishnan J, Herlitz LC, Stokes MB, Markowitz GS, D'Agati VD. The modern spectrum of renal biopsy findings in patients with diabetes. Clin J Am Soc Nephrol. 2013 Oct;8(10):1718-24. doi: 10.2215/CJN.02510213. Epub 2013 Jul 25.
PubMed 23886566Bi H, Chen N, Ling G, Yuan S, Huang G, Liu R. Nondiabetic renal disease in type 2 diabetic patients: a review of our experience in 220 cases. Ren Fail. 2011;33(1):26-30. doi: 10.3109/0886022X.2010.536292.
PubMed 21219202Byun JM, Lee CH, Lee SR, Moon JY, Lee SH, Lee TW, Ihm CG, Jeong KH. Renal outcomes and clinical course of nondiabetic renal diseases in patients with type 2 diabetes. Korean J Intern Med. 2013 Sep;28(5):565-72. doi: 10.3904/kjim.2013.28.5.565. Epub 2013 Aug 14.
PubMed 24009452Chong YB, Keng TC, Tan LP, Ng KP, Kong WY, Wong CM, Cheah PL, Looi LM, Tan SY. Clinical predictors of non-diabetic renal disease and role of renal biopsy in diabetic patients with renal involvement: a single centre review. Ren Fail. 2012;34(3):323-8. doi: 10.3109/0886022X.2011.647302. Epub 2012 Jan 17.
PubMed 22250665Liu MY, Chen XM, Sun XF, Zhou JH, Zhang XG, Zhu HY, Chen YZ, Liu SW, Wei RB, Tang L, Cai GY, Zhang L, Bai XY. Validation of a differential diagnostic model of diabetic nephropathy and non-diabetic renal diseases and the establishment of a new diagnostic model. J Diabetes. 2014 Nov;6(6):519-26. doi: 10.1111/1753-0407.12150. Epub 2014 Apr 25.
PubMed 24645648Wilfred DC, Mysorekar VV, Venkataramana RS, Eshwarappa M, Subramanyan R. Nondiabetic Renal Disease in type 2 Diabetes Mellitus Patients: A Clinicopathological Study. J Lab Physicians. 2013 Jul;5(2):94-9. doi: 10.4103/0974-2727.119850.
PubMed 24701101Chang TI, Park JT, Kim JK, Kim SJ, Oh HJ, Yoo DE, Han SH, Yoo TH, Kang SW. Renal outcomes in patients with type 2 diabetes with or without coexisting non-diabetic renal disease. Diabetes Res Clin Pract. 2011 May;92(2):198-204. doi: 10.1016/j.diabres.2011.01.017. Epub 2011 Feb 12.
PubMed 21320734
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Diabetic Causes of Chronic Kidney Disease in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT05021705
- Acronym / sponsor ID
- Non diabetic kidney disease
- Conditions
- Diabetic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 25 Aug 2021 (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.
Determination of the possible causes of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus with an atypical presentations of renal disease for proper management and thus improving renal outcome.
Detailed description
Diabetes mellitus (DM) is one of the most important health problems worldwide, and its prevalence is increasing. One of the complications of DM is diabetic kidney disease (DKD), which is responsible for over 40% of cases of chronic kidney disease requiring dialysis or kidney transplantation in the Western world.
The natural history of DKD in patients with type 1 DM is well characterized because we know the precise time of DM onset. Classically, these patients develop microalbuminuria, followed by macroalbuminuria in the first 15 years of DM. After 20 years of DM, progressive loss of glomerular filtration rate (GFR) develops. The majority of these patients have diabetic retinopathy. However, the natural history of renal disease in adults with DM type 2 is controversial. Before diagnosis, type 2 DM has usually evolved over several years but has remained unnoticed.
In 2007, KDOQI guidelines described characteristics of diabetic patients that indicate DKD involvement, namely the presence of macroalbuminuria or microalbuminuria with diabetic retinopathy in both types of DM, and in type 1 DM patients, over 10 years of DM. In addition, the guidelines summarize the characteristics that suggest the presence of non-diabetic kidney disease (NDKD): absence of diabetic retinopathy, fast decline of renal function, fast increase in proteinuria or nephrotic syndrome, refractory hypertension, active urinary sediment or signs or symptoms of systemic disease or>30% reduction in GFR within 2-3 months after starting the blockade of the renin-angiotensin-aldosterone system (RAAS).Yuan 2017 addressed the accuracy of a clinical diagnosis of DKD among diabetic patients following the criteria proposed by the KDOQI guidelines. Around 20% of patients did not meet KDOQI criteria for DKD in type 2 DM, suggesting a significant over estimation of DKD in this population. This high proportion of NDKD matches previous publications which demonstrated that about a third of patients with DM have biopsy-proven NDKD. The gold standard for diagnosis is renal biopsy. Renal biopsy in diabetic patients has focused on identifying NDKD, because these patients have different prognosis and therapy. The most frequent biopsy indications in diabetic patients are nephrotic syndrome, nephrotic proteinuria in patients with < 5 years of DKD evolution, microhaematuria, acute kidney injury and unexplained decline of renal function. Several groups have studied renal biopsies from diabetic patients, showing that the most frequent NDKD diagnoses are IgA nephropathy, membranous nephropathy and focal segmental glomerulosclerosis.
Different studies have shown that patients with DKD have a worse renal prognosis and that the prevalence of NDKD is high in diabetic patients. Therefore, it is important to accurately classify diabetic patients for DKD or NDKD. Yuan 2017 studied the differential characteristics between patients meeting clinical criteria to diagnose DKD according to KDOQI and misclassified patients. They showed that those patients lacking KDOQI-predicted DKD were more likely to have an active urine sediment and less likely to have developed macroalbuminuria or retinopathy prior to end-stage renal disease. Using the logistic regression analysis, diabetic retinopathy was the only factor independently associated with patients who met KDOQI criteria.
Kidney biopsy studies in diabetic patients have found predictive factors for NDKD: absence of diabetic retinopathy, low glycosylated haemoglobin, worse renal function, lower level of proteinuria, the presence of microscopic haematuria, older age and shorter DM evolution. Although the Yuan 2017 cohort is small and the diagnostic method was usually not renal biopsy, the results are in line with prior reports. However, recent studies have shown that patients with biopsy-proven DKD may be normoalbuminuric. Thus, further studies with larger cohorts and ideally renal biopsy confirmation are necessary to find factors better predicting NDKD in type 2 diabetic patients. These studies may help to design novel diagnostic tools to be applied by physicians in daily clinical practice. New therapeutic agents for the treatment of DKD have recently been characterized. Endothelin receptor antagonists, sodium glucose co-transporter2 inhibitors, incretins and agents targeting inflammation/fibrosis are probably the most promising candidates on top of the classical RAAS blockers. Therefore, it is mandatory that patients with diabetic renal disease are adequately classified, differentiating clearly those with DKD and those with NDKD. In addition, among those with DKD, a reliable classification within different pathological categories will be of great value to individualize treatment strategies.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 Diabetic patients
Key inclusion criteria (5 listed)
- Patients with type 2 diabetes mellitus having proteinuria associated with macroscopic or microscopic haematuria.
- Patients with type 2 diabetes mellitus with nephrotic syndrome appearing in the early stages of DM (less than 10 years of diagnosis) in absence of retinopathy or neuropathy.
- Patients with type 2 diabetes mellitus with unexplained renal failure or rapidly progressive renal dysfunction within few weeks or months.
- Patients with type 2 diabetes mellitus with symptoms and signs suggestive of systemic disease that may affect the kidney as SLE, vasculitis, multiple myeloma or lymphoma.
- Patients with type 2 diabetes mellitus with rapidly progressive glomerulonephritis.
Key exclusion criteria (4 listed)
- Patients with type 1 diabetes mellitus.
- DM with clinically, laboratory or radiologically evident CKD due to either chronic pyelonephritis, polycystic kidney disease or chronic obstructive nephropathy.
- DM with end stage renal disease (ESRD) with bilateral small kidneys.
- Patients with any contraindication to renal biopsy (systemic infections, bleeding tendency, low platelets, decrease prothrombin concentration).
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
renal biopsy
Time frame: baseline
The preferred site for renal biopsy was the lateral aspect of the lower pole of the left kidney under ultrasound guidance with the patient in the prone position and local anesthesia was used. An automated biopsy gun and a 16 gauge needle was used to ensure the biopsy sample contained a minimum of ten glomeruli. After biopsy compression on site of biopsy was done and strict follow up for the patient to exclude any complications. No complications were occurred for any patients. Renal biopsy specimens were prepared according to standard methods for light microscopy and immunoperoxidase. Electron microscopy was not routinely performed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Background: PubMed 26239461Espinel E, Agraz I, Ibernon M, Ramos N, Fort J, Seron D. Renal Biopsy in Type 2 Diabetic Patients. J Clin Med. 2015 May 18;4(5):998-1009. doi: 10.3390/jcm4050998.
- Background: PubMed 29423210Kramer A, Pippias M, Noordzij M, Stel VS, Afentakis N, Ambuhl PM, Andrusev AM, Fuster EA, Arribas Monzon FE, Asberg A, Barbullushi M, Bonthuis M, Caskey FJ, Castro de la Nuez P, Cernevskis H, des Grottes JM, Garneata L, Golan E, Hemmelder MH, Ioannou K, Jarraya F, Kolesnyk M, Komissarov K, Lassalle M, Macario F, Mahillo-Duran B, Martin de Francisco AL, Palsson R, Pechter U, Resic H, Rutkowski B, Santiuste de Pablos C, Seyahi N, Simic Ogrizovic S, Slon Roblero MF, Spustova V, Stojceva-Taneva O, Traynor J, Massy ZA, Jager KJ. The European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Registry Annual Report 2015: a summary. Clin Kidney J. 2018 Feb;11(1):108-122. doi: 10.1093/ckj/sfx149. Epub 2018 Jan 5.
- Background: PubMed 26890303Lytvyn Y, Bjornstad P, Pun N, Cherney DZ. New and old agents in the management of diabetic nephropathy. Curr Opin Nephrol Hypertens. 2016 May;25(3):232-9. doi: 10.1097/MNH.0000000000000214.
- Background: PubMed 12824208Kramer HJ, Nguyen QD, Curhan G, Hsu CY. Renal insufficiency in the absence of albuminuria and retinopathy among adults with type 2 diabetes mellitus. JAMA. 2003 Jun 25;289(24):3273-7. doi: 10.1001/jama.289.24.3273.
- Background: PubMed 17276798KDOQI. KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney Disease. Am J Kidney Dis. 2007 Feb;49(2 Suppl 2):S12-154. doi: 10.1053/j.ajkd.2006.12.005. No abstract available.
- Background: PubMed 28396744Yuan CM, Nee R, Ceckowski KA, Knight KR, Abbott KC. Diabetic nephropathy as the cause of end-stage kidney disease reported on the medical evidence form CMS2728 at a single center. Clin Kidney J. 2017 Apr;10(2):257-262. doi: 10.1093/ckj/sfw112. Epub 2016 Dec 22.
- Background: PubMed 27523263Bermejo S, Soler MJ, Gimeno J, Barrios C, Rodriguez E, Mojal S, Pascual J. Predictive factors for non-diabetic nephropathy in diabetic patients. The utility of renal biopsy. Nefrologia. 2016 Sep-Oct;36(5):535-544. doi: 10.1016/j.nefro.2016.06.006. Epub 2016 Aug 11. English, Spanish.
- Background: PubMed 26844777Fiorentino M, Bolignano D, Tesar V, Pisano A, Van Biesen W, D'Arrigo G, Tripepi G, Gesualdo L; ERA-EDTA Immunonephrology Working Group. Renal Biopsy in 2015--From Epidemiology to Evidence-Based Indications. Am J Nephrol. 2016;43(1):1-19. doi: 10.1159/000444026. Epub 2016 Feb 5.
- Background: PubMed 23886566Sharma SG, Bomback AS, Radhakrishnan J, Herlitz LC, Stokes MB, Markowitz GS, D'Agati VD. The modern spectrum of renal biopsy findings in patients with diabetes. Clin J Am Soc Nephrol. 2013 Oct;8(10):1718-24. doi: 10.2215/CJN.02510213. Epub 2013 Jul 25.
- Background: PubMed 21219202Bi H, Chen N, Ling G, Yuan S, Huang G, Liu R. Nondiabetic renal disease in type 2 diabetic patients: a review of our experience in 220 cases. Ren Fail. 2011;33(1):26-30. doi: 10.3109/0886022X.2010.536292.
- Background: PubMed 24009452Byun JM, Lee CH, Lee SR, Moon JY, Lee SH, Lee TW, Ihm CG, Jeong KH. Renal outcomes and clinical course of nondiabetic renal diseases in patients with type 2 diabetes. Korean J Intern Med. 2013 Sep;28(5):565-72. doi: 10.3904/kjim.2013.28.5.565. Epub 2013 Aug 14.
- Background: PubMed 22250665Chong YB, Keng TC, Tan LP, Ng KP, Kong WY, Wong CM, Cheah PL, Looi LM, Tan SY. Clinical predictors of non-diabetic renal disease and role of renal biopsy in diabetic patients with renal involvement: a single centre review. Ren Fail. 2012;34(3):323-8. doi: 10.3109/0886022X.2011.647302. Epub 2012 Jan 17.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Kidney Disease, run by Assiut University.
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 4 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: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
renal biopsy (time frame: baseline). 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 NCT05021705, which also lists 21 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 25 Aug 2021.