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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04006028
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Information provided by (Responsible Party):
Rennes University Hospital

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.

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : September 6, 2019
Estimated Study Completion Date : September 6, 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Non-diabetic renal disease [ Time Frame: one day ]
    A 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

Information from the National Library of Medicine

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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.

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04006028

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Contact: cecile ferragu 02 99 28 25 55
Contact: Direction de la recherche clinique DRI 02 99 28 25 55

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AP-HM, Hôpital de la Conception Not yet recruiting
Marseille, France, 13005
Contact: Noémie Jourde-Chiche   
Principal Investigator: Noémie Jourde-Chiche         
AP-HP, Hôpital Bichat-Claude Bernard Not yet recruiting
Paris, France, 75015
Contact: François Vrtovsnik   
Principal Investigator: François Vrtovsnik         
AP-HP, Hôpital Necker-Enfants Malades Not yet recruiting
Paris, France, 75015
Contact: Dominique Joly    01 44 49 54 16   
Principal Investigator: Dominique Joly         
Rennes University Hospital Recruiting
Rennes, France, 35000
Contact: jonathan chemouny   
Hôpital Bretonneau Not yet recruiting
Tours, France, 37044
Contact: Jean Michel Halimi   
Principal Investigator: Jean Michel Halimi         
Sponsors and Collaborators
Rennes University Hospital
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Principal Investigator: Jonathan Chemouny Rennes University Hospital

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Responsible Party: Rennes University Hospital Identifier: NCT04006028     History of Changes
Other Study ID Numbers: 35RC19_30031_RIB-R2D2
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rennes University Hospital:
Type 2 diabetes
renal biopsy
diabetic nephropathy

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency