The WHO (World Health Organisation) estimated the prevalence of diabetes to be 422 million people in 2014, compared to 108 million in 1980. This has led to an increasing number of diabetic patients referred to nephrologists for diagnostic purposes. Diabetic nephropathy is the most common renal disease in this population and is usually a presumptive diagnosis based on clinical and biological features although microscopic examination of a renal sample acquired through renal biopsy is the only way to be certain of this diagnosis. However, kidney biopsy is an invasive procedure carrying a low but incontestable risk of adverse event such as post-procedural pain and bleeding. Consequently, nephrologist around the world feel that renal biopsy should only be performed in patients with type 2 diabetes to detect non-diabetic renal disease, when the diagnosis of diabetic nephropathy is dubious or unlikely. This likeliness is based on the presence or absence of typical feature such as diabetic retinopathy, hematuria, progressive decline of renal function or increase of proteinuria, long duration of diabetes, nephrotic syndrome. These feature were identified by the comparison of patients with type 2 diabetes and non-diabetic renal disease (alone or associated to diabetic nephropathy) and isolated diabetic nephropathy.
However, it is not known if the presence (or absence) of these atypical features by themselves are indeed signs of non-diabetic renal disease and necessitate to perform renal biopsy. The aim of the study is to determine if these atypical features are relevant indications to perform renal biopsy. To answer this question, will be analyze the medical records of patients with type 2 diabetes who underwent renal biopsy in five French nephrology center to determine, in each case, the indication of the biopsy and if this latter benefitted the patients.
In addition, will be evaluate the prognosis value of the Renal Pathology Society classification of diabetic nephropathy in patients with type 2 diabetes and diabetic nephropathy.
Condition or disease |
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Type 2 Diabetes, Chronic Kidney Disease |
The purpose of the study is to evaluate the accuracy of kidney biopsies indications in patients with type 2 diabetes to diagnose non-diabetic renal disease based on canonical atypical features (Absence of diabetic retinopathy, Low or rapidly decreasing GFR, Rapidly increasing proteinuria or nephrotic syndrome and Presence of active urinary sediment. This study is a retrospective observational case only study, recruiting patients over 18 years old with type 2 diabetes who underwent kidney biopsy in five French nephrology centers between 2006 and 2015.
Will be collected demographical, clinical and biological data at the time of the renal biopsy and at the last follow-up from the patients' medical charts.
Indications for renal biopsy will be categorized as
Will be also perform a classical analysis by assessing the association of clinical and biological feature such as HbA1c, diabetes duration, absence of diabetic retinopathy,… with the presence of a non-diabetic renal disease.
In addition, the biopsy samples will be scored according to the RPS diabetic nephropathy classification to evaluate the prognostic value of this classification.
Study Type : | Observational |
Actual Enrollment : | 500 participants |
Observational Model: | Case-Only |
Time Perspective: | Retrospective |
Official Title: | Retrospective Study of Renal Biopsies Indications and Their Results in Patients With Type-2 Diabetes : a Multicenter Study |
Actual Study Start Date : | June 6, 2019 |
Actual Primary Completion Date : | September 17, 2019 |
Actual Study Completion Date : | September 17, 2019 |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
France | |
AP-HM, Hôpital de la Conception | |
Marseille, France, 13005 | |
AP-HP, Hôpital Bichat-Claude Bernard | |
Paris, France, 75015 | |
Rennes University Hospital | |
Rennes, France, 35000 | |
Hôpital Bretonneau | |
Tours, France, 37044 |
Principal Investigator: | Jonathan Chemouny | Rennes University Hospital |
Tracking Information | |||||
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First Submitted Date | June 26, 2019 | ||||
First Posted Date | July 2, 2019 | ||||
Last Update Posted Date | September 1, 2020 | ||||
Actual Study Start Date | June 6, 2019 | ||||
Actual Primary Completion Date | September 17, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Non-diabetic renal disease [ Time Frame: one day ] proportion of histological diagnosisof non diabetic renal disease (with or without diabetic nephropathy)
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Original Primary Outcome Measures |
Non-diabetic renal disease [ Time Frame: one day ] A histological diagnosisof non diabetic renal disease (with or without diabetic nephropathy)
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Kidney Biopsy Indications in Type 2 Diabetes Patients | ||||
Official Title | Retrospective Study of Renal Biopsies Indications and Their Results in Patients With Type-2 Diabetes : a Multicenter Study | ||||
Brief Summary |
The WHO (World Health Organisation) estimated the prevalence of diabetes to be 422 million people in 2014, compared to 108 million in 1980. This has led to an increasing number of diabetic patients referred to nephrologists for diagnostic purposes. Diabetic nephropathy is the most common renal disease in this population and is usually a presumptive diagnosis based on clinical and biological features although microscopic examination of a renal sample acquired through renal biopsy is the only way to be certain of this diagnosis. However, kidney biopsy is an invasive procedure carrying a low but incontestable risk of adverse event such as post-procedural pain and bleeding. Consequently, nephrologist around the world feel that renal biopsy should only be performed in patients with type 2 diabetes to detect non-diabetic renal disease, when the diagnosis of diabetic nephropathy is dubious or unlikely. This likeliness is based on the presence or absence of typical feature such as diabetic retinopathy, hematuria, progressive decline of renal function or increase of proteinuria, long duration of diabetes, nephrotic syndrome. These feature were identified by the comparison of patients with type 2 diabetes and non-diabetic renal disease (alone or associated to diabetic nephropathy) and isolated diabetic nephropathy. However, it is not known if the presence (or absence) of these atypical features by themselves are indeed signs of non-diabetic renal disease and necessitate to perform renal biopsy. The aim of the study is to determine if these atypical features are relevant indications to perform renal biopsy. To answer this question, will be analyze the medical records of patients with type 2 diabetes who underwent renal biopsy in five French nephrology center to determine, in each case, the indication of the biopsy and if this latter benefitted the patients. In addition, will be evaluate the prognosis value of the Renal Pathology Society classification of diabetic nephropathy in patients with type 2 diabetes and diabetic nephropathy. |
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Detailed Description |
The purpose of the study is to evaluate the accuracy of kidney biopsies indications in patients with type 2 diabetes to diagnose non-diabetic renal disease based on canonical atypical features (Absence of diabetic retinopathy, Low or rapidly decreasing GFR, Rapidly increasing proteinuria or nephrotic syndrome and Presence of active urinary sediment. This study is a retrospective observational case only study, recruiting patients over 18 years old with type 2 diabetes who underwent kidney biopsy in five French nephrology centers between 2006 and 2015. Will be collected demographical, clinical and biological data at the time of the renal biopsy and at the last follow-up from the patients' medical charts. Indications for renal biopsy will be categorized as
Will be also perform a classical analysis by assessing the association of clinical and biological feature such as HbA1c, diabetes duration, absence of diabetic retinopathy,… with the presence of a non-diabetic renal disease. In addition, the biopsy samples will be scored according to the RPS diabetic nephropathy classification to evaluate the prognostic value of this classification. |
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Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | All patients with type 2 diabetes who underwent a first renal biopsy in one of the participating centers (nephrology unit of Pontchaillou Hospital in Rennes, Conception hospital in Marseille, Bichat and Necker hospitals in Paris and Bretonneau hospital in Tours) will be included in the study unless they meet one of the exclusion criteria. | ||||
Condition | Type 2 Diabetes, Chronic Kidney Disease | ||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
500 | ||||
Original Estimated Enrollment | Same as current | ||||
Actual Study Completion Date | September 17, 2019 | ||||
Actual Primary Completion Date | September 17, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04006028 | ||||
Other Study ID Numbers | 35RC19_30031_RIB-R2D2 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Rennes University Hospital | ||||
Study Sponsor | Rennes University Hospital | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Rennes University Hospital | ||||
Verification Date | May 2019 |