Chronic Kidney Disease, Healthy
Conditions
Keywords
Chronic kidney disease, GFR, Inulin, 51Cr-EDTA, ASDKP-NH2, Healthy male 18-35 yrs old, non smokers, non allergic, Or Male/female 18-80 yrs old with chronic Kidney disease
Brief summary
The purpose of the study is to validate a new reference marker for evaluation of renal function (glomerular filtration rate).
Detailed description
Chronic kidney disease (CKD) is a worldwide public health problem with an increasing incidence and prevalence, poor outcomes (kidney failure, complications of decreased kidney function and cardiovascular disease), and high cost. Some of the adverse outcomes can be prevented or delayed by early detection and treatment. However, CKD is frequently underdiagnosed and undertreated. The glomerular filtration rate (GFR) is considered as the best index of renal function. The clinical action plan promoted by International Guidelines groups refers to GFR values. Despite recent improvements, prediction equations developed in order to estimate GFR elicit a huge lack of accuracy when considering the individual patient, especially in case of early CKD. Rigorous assessment of GFR requires the measurement of urinary or plasma clearance of an ideal exogenous filtration marker which is either non-radioactive (inulin, iothalamate, or iohexol) or radioactive ( 51Cr-EDTA or 99mTc DTPA. Measuring clearance with the use of exogenous markers is difficult to perform in clinical practice because it is expensive and cumbersome and needs specialised laboratories and thus, is underused. There is an unmet need for the development of a new non-radioactive GFR tracer that could combine both the analytical accuracy of radioactive tracers and the simplicity of its measurement. Such a tracer should improve clinical care and follow-up of patients.
Interventions
DRUGAcSDKP-NH2 inuline
Once intravenous administration of 100 µg or less
DRUGAcSDKP-NH2 Cr-EDTA
Once intravenous administration of 100 µg or less
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Phase I: 18-35 years male * Phase I: healthy volunteers * Phase II: 18-80 years patients (both sex) * Phase II: with Chronic Kidney Disease
Exclusion criteria
* Phase I: Smokers * Phase I: Allergic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| glomerular filtration rate | between day 7 and day 21 | NAcSDKP clearance for GFR measurement is compared to inuline and 51Cr-EDTA clearance in two phase I studies in 50 healthy subjects. GFR is first assessed at equilibrium by measuring urinary clearances of inuline and NAcSDKP continuously co-infused after a loading dose; and second by plasma clearances of 51Cr-EDTA and NAcSDKP after a single IV bolus. Optimal conditions for using NAcSDKP as a marker for GFR and the tolerability of the peptide are assessed during these studies. Then, a phase IIa study will be performed to compare the 2 methods in 45 patients with various degrees of renal failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety | One month extended to 3 months safety follow up | all adverse events (clinical or biological adverse events) |
Countries
France
Outcome results
None listed