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

Retrospective Study of Renal Biopsies Indications and Their Results in Patients With Type-2 Diabetes : a Multicenter Study

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • AP-HM, Hôpital de la Conception
  • Paris, France, 75015
    • AP-HP, Hôpital Bichat-Claude Bernard
  • Rennes, France, 35000
    • Rennes University Hospital
  • Tours, France, 37044
    • Hôpital Bretonneau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-diabetic renal disease	proportion of histological diagnosisof non diabetic renal disease (with or without diabetic nephropathy)	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal survival	Time from renal biopsy to end-stage renal disease (defined as initiation of dialysis or kidney transplantation)	one day
Patient survival	Patients' death and the time of this outcome from renal biopsy	one day

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Jonathan Chemouny, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 6, 2019
• Primary Completion (ACTUAL): September 17, 2019
• Study Completion (ACTUAL): September 17, 2019

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (ACTUAL): July 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 28, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: proteinuria; Type 2 diabetes; diabetic nephropathy; hematuria; renal biopsy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Urologic Diseases; Endocrine System Diseases; Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 35RC19_30031_RIB-R2D2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No