Type 2 Diabetes, Chronic Kidney Disease Clinical Trial
— RIB-R2D2Official title:
Retrospective Study of Renal Biopsies Indications and Their Results in Patients With Type-2 Diabetes : a Multicenter Study
| Verified date | May 2019 |
| Source | Rennes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | September 17, 2019 |
| Est. primary completion date | September 17, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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.) |
| Country | Name | City | State |
|---|---|---|---|
| France | AP-HM, Hôpital de la Conception | Marseille | |
| France | AP-HP, Hôpital Bichat-Claude Bernard | Paris | |
| France | Rennes University Hospital | Rennes | |
| France | Hôpital Bretonneau | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| Rennes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Non-diabetic renal disease | proportion of histological diagnosisof non diabetic renal disease (with or without diabetic nephropathy) | one day | |
| Secondary | Renal survival | Time from renal biopsy to end-stage renal disease (defined as initiation of dialysis or kidney transplantation) | one day | |
| Secondary | Patient survival | Patients' death and the time of this outcome from renal biopsy | one day |