Type 2 Diabetes, Chronic Kidney DiseaseRIB-R2D2NCT04006028
Kidney Biopsy Indications in Type 2 Diabetes Patients
An observational study of Type 2 Diabetes, Chronic Kidney Disease, run by Rennes University Hospital at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Chronic Kidney Disease
- How many people
- 500 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Jun 2019to 17 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
4 sites in 1 country.
France4 sites
AP-HM, Hôpital de la Conception
Marseille, 13005
AP-HP, Hôpital Bichat-Claude Bernard
Paris, 75015
Rennes University Hospital
Rennes, 35000
Hôpital Bretonneau
Tours, 37044
About this study
Official title: 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.
Read the 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
- 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)
- Brutal nephrotic syndrome in the absence of the above criterion
- Rapid decline of GFR (defined as 50 % eGFR decline over >1 week but < 1 year) in the absence of criteria 1-2
- Absence of proteinuria in the absence of criteria 1-3
- Rapid increase of proteinuria in the absence of criteria 1-4
- Presence of hematuria in the absence of criteria 1-5
- 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.
- Conditions
- Type 2 Diabetes, Chronic Kidney Disease
- Keywords
- Type 2 diabetes, renal biopsy, diabetic nephropathy, proteinuria, hematuria
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Diabetic Nephropathies, Proteinuria, Hematuria
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-diabetic renal disease
proportion of histological diagnosisof non diabetic renal disease (with or without diabetic nephropathy)
Measured: one day
Secondary outcomes (2)
Renal survival
Time from renal biopsy to end-stage renal disease (defined as initiation of dialysis or kidney transplantation)
Measured: one day
Patient survival
Patients' death and the time of this outcome from renal biopsy
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start6 Jun 2019
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes, Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Chemouny, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006028
- Sponsor's protocol ID
- 35RC19_30031_RIB-R2D2
- Acronym
- RIB-R2D2
- Status last verified
- May 2019
- First submitted
- 26 Jun 2019
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Renal Biopsies Indications and Their Results in Patients With Type-2 Diabetes : a Multicenter Study
- ClinicalTrials.gov ID
- NCT04006028
- Acronym / sponsor ID
- RIB-R2D2 / 35RC19_30031_RIB-R2D2
- Conditions
- Type 2 Diabetes, Chronic Kidney Disease
- Keywords
- Type 2 diabetes, renal biopsy, diabetic nephropathy, proteinuria, hematuria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 2 Jul 2019 (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.
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
- 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)
- Brutal nephrotic syndrome in the absence of the above criterion
- Rapid decline of GFR (defined as 50 % eGFR decline over >1 week but < 1 year) in the absence of criteria 1-2
- Absence of proteinuria in the absence of criteria 1-3
- Rapid increase of proteinuria in the absence of criteria 1-4
- Presence of hematuria in the absence of criteria 1-5
- 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
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.)
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
Non-diabetic renal disease
Time frame: one day
proportion of histological diagnosisof non diabetic renal disease (with or without diabetic nephropathy)
2 secondary outcomes
Renal survival
Time frame: one day
Patient survival
Time frame: one day
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 1 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Jonathan Chemouny principal investigator
Rennes University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, Chronic Kidney Disease, run by Rennes University Hospital at 4 sites in France.
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 3 inclusion and 3 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Non-diabetic renal disease (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2020.