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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04916132
Other study ID # PRIMETIME2
Secondary ID H-20080050
Status Recruiting
Phase
First received
Last updated
Start date August 10, 2021
Est. completion date December 31, 2043

Study information

Verified date February 2024
Source Herlev Hospital
Contact Marie Møller
Phone +4561695364
Email marie.moeller@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

a prospective, observational, multi-center study with a cohort of 300 patients with Type 2 diabetes and macroalbuminuria. Prospectively we will collect kidney biopsies and analyse the transciptome of the kidney tissue and other biomarkers from blood, faeces, urine, proteomic- and metabolomic profiles and DNA-variants. Thereby we hope to be able to discover molecular and clinical profiles, that can help us in the diagnosis of DKD, and to identify different risks of progression that can benefit from different forms of personalized treatment.


Description:

The PRIMETIME project is made to bring together molecular, translational and clinical scientists to create collaborations and build a scientific bridge between diabetology, nephrology, clinical biochemistry, and pathology. The ultimately goal is to bring forward an improved understanding of the most frequent cause of end stage renal disease: DKD. We aim to improve the diagnostic accuracy as well as the treatment precision by investigating in detail the features of histology and protein expression in both retrospective(WP1) and prospective(WP2) kidney biopsy material. PRIMETIME WP2 is a prospective, observational, multi-center study with a cohort of 300 patients. We plan to create a systematically unselected cohort of patients with Type2 diabetes and macroalbuminuria as a sign of kidney injury. Prospectively we will collect research kidney biopsies and other biomarkers from blood, faeces, urine, proteomic- and metabolomic profiles and DNA-variants. The biopsies will be thoroughly investigated with cutting-edge molecular technologies and associated to the biomarkers, disease course and clinical outcome. The participants will afterward be followed in 20 years.Thereby we hope to be able to discover molecular and clinical profiles, that can help us in the diagnosis of DKD, and to identify different risks of progression that can benefit from different forms of personalized treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 31, 2043
Est. primary completion date December 31, 2043
Accepts healthy volunteers
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria: - Age = 18 years - Written informed consent - Diagnosis with T2DM according to the American diabetes Association (20) - eGFR >30 mL/min/1.73 m2 (maximum six months old) - urine-albumin/creatinine-ratio (uACR) > 700 mg/g or 24 hours urine albumin >700 mg on more than one measurement Exclusion Criteria: - Signs of acute kidney failure according to the KDIGO classification (21) at the time for kidney biopsy or the last 6 months before kidney biopsy - Factors that increases the risk of complications due to kidney biopsy: - Hemoglobin < 6 mmol/L - INR >1,4 at the time for biopsy - Platelet count < 100 x 109/l - Uncontrolled high blood pressure (defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg) - Only one functioning kidney - Evidence of urinary tract obstruction or hydronephrosis at the time of biopsy - Multiple bilateral kidney cysts - Kidney infection, peri-renal infection, or cutaneous infection that overlies the kidney at time for biopsy - Unwilling to receive blood transfusion - Unable to lie flat in bed six hours after biopsy - Any other contra-indications for percutaneous kidney biopsy according to local clinical guidelines - Unable to understand written and oral information - Kidney transplant recipient - Previous medical kidney biopsy - Women who are pregnant or planning to become pregnant before the kidney biopsy is performed - Treatment with Marcoumar (all other anticoagulants are accepted) - High thromboembolic risk combined with held in anticoagulation therapy according to the report "Perioperative regulation of antithrombotic treatment" (PRAB) (22) - mechanical heart valve - atrial fibrillation AND CHA2DS2-VASc> 5 and/or stroke within the last three months - recurrent venous thromboembolism OR venous thromboembolism within the last three months - less than 6 weeks after uncomplicated Acute Coronary Syndrome (ACS) with or without revascularization (Percutaneous Coronary Intervention (PCI)) with Bare Metal Stents (BMS) or Coronary Artery Bypass Grafting (CABG)) - less than 3 months after uncomplicated ACS with revascularization (PCI with Drug Eluting Stent (DES)) - less than 9-12 months after complicated ACS (e.g. reinfarction or stent thrombosis) - less than 1 month after revascularization in individuals with stable Coronary Artery Disease (CAD) (PCI with BMS or CABG) - less than 3 months after revascularization in individuals with stable CAD (PCI with DES) - less than 3 months after stroke, or Transient Ischemic Attack (TIA) - Inability to withdraw nonsteroidal anti-inflammatory drugs (NSAID) 7 days before biopsy If a participant meets one or more exclusion criteria, that are reversible, the participant can be rescreened later on, to evaluate whether or not the participant now is qualified for participation.

Study Design


Intervention

Procedure:
Kidney Biopsy
Harvesting of kidney tissue from people with type 2 diabetes and albuminuria for subsequent analysis

Locations

Country Name City State
Denmark Aalborg universitetshospital Aalborg
Denmark Rigshospitalet Copenhagen København Ø
Denmark Steno Diabetes Center Copenhagen Copenhagen Gentofte
Denmark Regionshospitalet Gødstrup Gødstrup
Denmark Herlev Hospital Herlev
Denmark Kristine D Schandorff Hillerød
Denmark Holbæk Hospital Holbæk
Denmark Sjællands Universitetshospital, Køge Køge
Denmark Nykøbing Falster Sygehus Nykøbing Falster Nykøbing F
Denmark Odense universitetshospital Odense
Denmark Sjællands Universitetshospital, Roskilde Roskilde
Denmark Aarhus Universitetshospital, Skejby Skejby Aarhus
Denmark Slagelse Sygehus Slagelse

Sponsors (18)

Lead Sponsor Collaborator
Herlev Hospital Aalborg University Hospital, Aarhus University Hospital, Gødstrup Hospital, Gubra ApS, Hillerod Hospital, Denmark, Holbaek Sygehus, Michigan Kidney Translational Medical Center, Novo Nordisk A/S, Nykøbing Falster County Hospital, Odense University Hospital, Rigshospitalet, Denmark, Slagelse Sygehus, Steno Diabetes Center Copenhagen, Steno Diabetes Center Nordjylland, Steno Diabetes Center Sjaelland, The Novo Nordisk Foundation Center for Basic Metabolic Research, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence To investigate the prevalence of biopsy-proven diabetic nephropathy in individuals with T2DM with severe albuminuria; urine albumin/creatinine ratio (UACR) >700 mg/g. From baseline to end inclusion (3 years)
Secondary Improved clinical diagnosis To investigate whether clinical variables, transcriptomic, proteomic and/or metabolomic profiles as well as genetic variation can predict the presence of diabetic nephropathy in a kidney biopsy. From baseline to end inclusion (3 years)
Secondary diabetic retinopathy To describe the sensitivity and specificity of diabetic retinopathy in predicting biopsy-proven diabetic nephropathy From baseline to end inclusion (3 years)
Secondary Kidney Biopsy describe the prognostic value of different histological and molecular findings on kidney biopsy in individuals with biopsy-proven diabetic nephropathy From baseline to end of followup (20 years)
Secondary non-diabetic nephropathy vs. biopsy-proven diabetic nephropathy describe the prognostic value of different histological and molecular findings on the kidney biopsy in individuals with non-diabetic nephropathy compared to biopsy-proven diabetic nephropathy. From baseline to end of followup (20 years)
Secondary proteomic and metabolomic describe the prognostic value of the proteomic and metabolomic profiles in biopsy-proven diabetic nephropathy. From baseline to end of followup (20 years)
Secondary genetic variants describe the prognostic value of different forms of genetic variation in biopsy-proven diabetic nephropathy From baseline to end of followup (20 years)
Secondary Microbiome describe the prognostic value of different compositions of the microbiome and its relation to biopsy and clinical findings From baseline to end of followup (20 years)
Secondary Annual changes in kidney status Annual changes in kidney status (defined by yes/no: initiation of dialysis, kidney transplantation, renal death or decrease in eGFR > 40 % compared to eGFR at baseline) From baseline to end of followup (20 years)
Secondary Annual decline in eGRF Annual decline in eGRF From baseline to end of followup (20 years)
Secondary Annual changes in albuminuria. Annual changes in albuminuria. From baseline to end of followup (20 years)
Secondary Annual events of cardiovascular disease Events of cardiovascular disease (fatal CV events, non-fatal stroke, non-fatal myocardial infarction, hospitalization for heart failure, PCI or bypass surgery (heart or legs), amputations due to ischemia, and unstable angina) From baseline to end of followup (20 years)
Secondary Death Death (any cause). From baseline to end of followup (20 years)
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