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出境医 / 临床实验 / Kidney Biopsy Indications in Type 2 Diabetes Patients (RIB-R2D2)

Kidney Biopsy Indications in Type 2 Diabetes Patients (RIB-R2D2)

Study Description
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.


Condition or disease
Type 2 Diabetes, Chronic Kidney Disease

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

  1. Atypical feature of etiological significance in the presence of any atypical feature not listed below (including acute kidney injury as defined by the stage 1 of KDIG guidelines)
  2. Brutal nephrotic syndrome in the absence of the above criterion
  3. Rapid decline of GFR (defined as 50 % eGFR decline over >1 week but < 1 year) in the absence of criteria 1-2
  4. Absence of proteinuria in the absence of criteria 1-3
  5. Rapid increase of proteinuria in the absence of criteria 1-4
  6. Presence of hematuria in the absence of criteria 1-5
  7. Absence of diabetic retinopathy in the absence of criteria 1-6 Will be evaluate the actual probability to reach a non-diabetic renal disease for each of these indications.

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 Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Non-diabetic renal disease [ Time Frame: one day ]
    proportion of histological diagnosisof non diabetic renal disease (with or without diabetic nephropathy)


Secondary Outcome Measures :
  1. Renal survival [ Time Frame: one day ]
    Time from renal biopsy to end-stage renal disease (defined as initiation of dialysis or kidney transplantation)

  2. Patient survival [ Time Frame: one day ]
    Patients' death and the time of this outcome from renal biopsy


Eligibility Criteria
Layout table for eligibility information
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
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.
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes
  • Over 18 year old
  • With a first non-transplant renal biopsy for non-tumoral indication between 01/01/2006 and 12/31/2015

Exclusion Criteria:

  • Patients having expressed their opposition regarding the usage of their data in this research
  • Patients with previous renal biopsy
  • Patients with non-type 2 diabetes (type 1, post-pancreatitis, genetic, etc.)
Contacts and Locations

Locations
Layout table for location information
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
Sponsors and Collaborators
Rennes University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jonathan Chemouny Rennes University Hospital
Tracking Information
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
 (submitted: August 28, 2020)
Non-diabetic renal disease [ Time Frame: one day ]
proportion of histological diagnosisof non diabetic renal disease (with or without diabetic nephropathy)
Original Primary Outcome Measures
 (submitted: July 1, 2019)
Non-diabetic renal disease [ Time Frame: one day ]
A histological diagnosisof non diabetic renal disease (with or without diabetic nephropathy)
Change History
Current Secondary Outcome Measures
 (submitted: July 1, 2019)
  • Renal survival [ Time Frame: one day ]
    Time from renal biopsy to end-stage renal disease (defined as initiation of dialysis or kidney transplantation)
  • Patient survival [ Time Frame: one day ]
    Patients' death and the time of this outcome from renal biopsy
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.

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

  1. Atypical feature of etiological significance in the presence of any atypical feature not listed below (including acute kidney injury as defined by the stage 1 of KDIG guidelines)
  2. Brutal nephrotic syndrome in the absence of the above criterion
  3. Rapid decline of GFR (defined as 50 % eGFR decline over >1 week but < 1 year) in the absence of criteria 1-2
  4. Absence of proteinuria in the absence of criteria 1-3
  5. Rapid increase of proteinuria in the absence of criteria 1-4
  6. Presence of hematuria in the absence of criteria 1-5
  7. Absence of diabetic retinopathy in the absence of criteria 1-6 Will be evaluate the actual probability to reach a non-diabetic renal disease for each of these indications.

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
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
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.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 1, 2019)
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:

  • Patients with type 2 diabetes
  • Over 18 year old
  • With a first non-transplant renal biopsy for non-tumoral indication between 01/01/2006 and 12/31/2015

Exclusion Criteria:

  • Patients having expressed their opposition regarding the usage of their data in this research
  • Patients with previous renal biopsy
  • Patients with non-type 2 diabetes (type 1, post-pancreatitis, genetic, etc.)
Sex/Gender
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Rennes University Hospital
Study Sponsor Rennes University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jonathan Chemouny Rennes University Hospital
PRS Account Rennes University Hospital
Verification Date May 2019

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