DYNAMic Renal Assessment: NOvel Methods to Assess KIDNEY Functional Reserve
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Diseases. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This is a feasibility study to assess new, more practical ways of measuring renal reserve.
Detailed description
Quantification of glomerular filtration rate (GFR) over time is the standard assessment of kidney function. In clinical practice, the endogenous marker, 'serum creatinine' concentration, is used as a static assessment of kidney function to estimate GFR. However, serum creatinine fails to increase until at least 50% of kidney tissue is lost,\[2\] thus is an inadequate indicator of early CKD.
GFR like many other physiological processes is not static and augments temporarily to stimuli such as exercise and protein intake, by up to 25% from baseline in healthy individuals.\[3\] Similar to cardiac function stress tests which predict adverse outcomes, inability to respond to renal stressors or 'reduced renal reserve' has been demonstrated to occur prior to development of CKD (e.g. in patients with diabetes and previous acute kidney injury (AKI)) and is associated with vulnerability to future AKI, despite the presence of apparently normal kidney function measured by serum creatinine concentration.\[4\] Renal reserve is lost with progressive CKD,\[4\] and has also been demonstrated to relate to severity of histological lesions.\[5\]
Current measurements of renal reserve (stimulated increase in GFR due to augmented renal blood flow above basal fasting values) involve administration of a compound that is freely filtered by the glomerulus, unaffected by tubular function and is physiologically inert, with assessment before and after an oral protein load or amino acid infusion which induces arterial vasodilation, increasing renal blood flow and GFR
The study proposes a comparison of two novel methods of 'dynamic renal function testing' with renal reserve testing.
Interventions
- Drug Dapagliflozin
On Day 3 to 16, participants will take 10mg dapaglifozin (SGLT-2 inhibitor) orally once daily.
Primary outcome measures
- Change in eGFR from baseline to 2hours after oral protein load [Time frame: 2 hours]
Eligibility criteria
Inclusion:
- Patients with sickle cell nephropathy, diagnosed clinically or histologically. Sickle Cell patients will be confirmed Hb SS and eGFR (CKD-EPI) ≥ 135 ml/min/1.73m2 OR
- Previous living kidney donation
- Age ≥ 4No contraindication or known allergy to any trial medications.
- Willing and able to provide written informed consent
Exclusion:
- Aged \< 40
- Unable or unwilling to provide informed consent
- Breastfeeding or pregnant women
- Patients involved in other interventional research studies.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United Kingdom · 1 center
- King's College Hospital — London
Identifiers
NCT: NCT06572215 · KCH23-128