The Practicality and Utility of Measured vs Estimated GFR in adCKD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorManchester University NHS Foundation Trust
About this trial
The goal of this observational study is to assess if new ways of measuring kidney function can better predict when individuals will become symptomatic due to kidney failure, and whether residual kidney function can be accurately measured in those already on dialysis.
The main questions the study is trying to answer is whether measuring kidney function by clearance of iohexol is comparable to the current standard of care methods.
In addition to routine care, participants will:
* undergo a brief clinical assessment * be given an injection of iohexol and asked to perform 4 finger prick blood tests over 24 hours, recording the time of each sample. Samples will be returned in person or posted back * be asked to complete a questionnaire on their experience
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (18 year s or older)
Able to give informed consent
Progressive chronic kidney disease predicted to start renal replacement therapy in the next 6 months OR established on dialysis (either haemodialysis or peritoneal) with residual renal function (Urine output >100ml/day)
Disqualifiers
Under 18 years
Known allergy to iodinated contrast media
Unable to perform fingerprick blood testing
Unable to comply with urine collection
Trial population
Patients under the care of Manchester Universities NHS Foundation Trust Nephrology Department who meet the above inclusion / exclusion criteria
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Iohexol Inj 300 MG/ML Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
Diagnostic testInjection of 3235mg iohexol (equivalent to 5ml Omnipaque 300) followed by serial dried blood spot testing over 24 hours to be measured for iohexol concentration and used to calculate clearance.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Advanced Chronic Kindney Disease expected to need dialysis in the next 6 months1 intervention
Group B: End stage kidney disease established on peritoneal dialysis with >100ml / 24hours urine output1 intervention
Group C: End stage kidney disease established on haemodialysis with >100ml / 24hour urine output1 intervention
Trial outcomes
Primary outcomes
1
Iohexol measured glomerular filtration rate
Serial timed dried blood samples taken over 24 hours after injection of iohexol will be tested for iohexol concentration. The measured glomerular filtration rate will be calculated by the rate of clearance (the area under the curve for concentration vs time plot) and corrected for body surface area (derived by weight and height) to give a value in ml/min/1.73m\^2
Time frame
Assessed at each study visit through study completion, up to 6 months.2
Creatinine based estimated glomerular filtration rate (Standard of care measure for kidney function in those not receiving renal replacement therapy)
Serum creatinine concentration (micromoles/liter) will be measured from a venous blood sample. This concentration along with participant age and sex will be used to calculate estimated glomerular filtration rate, corrected for body surface area, from internationally validated mathematical equations. Resuilts are reported in ml/min/1.73m\^2
Time frame
Assessed at each study visit while the participant has not yet started renal replacement therapy through study completion, up to 6 months.3
Creatinine clearance corrected for body surface area (Standard of care measure for kidney function in those receiving peritoneal dialysis)
Creatinine clearance will be calculated from paired blood (serum creatinine concentration) and 24 hour urine (urine creatinine concentration and volume) using validated mathematical equations. This will be corrected for body surface area (derived by weight and height) to give a value in ml/min/1.73m\^2
Time frame
Assessed at any study visit where the participant is established on peritoneal dialysis through to study completion, usually 48 hours after this visit.4
Residual renal clearance of creatinine and urea (Standard of care measure for kidney function in those receiving haemodialysis)
Renal function in haemodialysis can be derived from averaging the measured creatinine and urea clearance. This is calculated using internationally validated equations and requires multiple measurements. This includes: Pre- and post- dialyisis serum creatinine \& urea concentrations from 1st dialysis visit; timed urine collection between dialysis periods measured for urine creatinine and urea concentration, volume, time of collection and time between end of dialysis visit and starting urine collection; And predialsyis serum creatinine and urea from subsequent (2nd) dialysis session. This will be corrected for body surface area (derived by weight and height) to give a value in ml/min/1.73m\^2
Time frame
Assessed at any study visit where the participant is established on haemodialysis dialysis through to study completion, usually 48 hours after this visit.Secondary outcomes
1
Patient acceptability of performing measured GFR as assessed by participant questionnaire
Acceptability measured from participant questionnaire. Statements are provided questioning how easy the test was to perform, their willingness to carry out the test regularly and their preference of mGFR compared to standard of care. Responses are marker on a 5 point scale from strongly disagree to strongly agree.
Time frame
24 hours. The questionnaire should take no more than 5 minutes but requires completion of the participant's first 24 hour mGFR testing to be done.2
Number of iohexol finger prick samples correctly returned
Proportion of iohexol finger prick samples correctly taken, correctly labelled and returned as well as producing a plausible result will be used as a measure of feasibility of iohexol mGFR by finger prick testing in routine care.
Time frame
Assessed at each study visit through study completion, up to 6 months.3
Single sample iohexol measured GFR
measured GFR using a single iohexol concentration at 24 hours (rather that multiple samples). The same samples taken for the primary outcome 1 will be used for thi.
Time frame
Assessed at each study visit through study completion, up to 6 months.4
eGFR calculated by novel markers
eGFR calculated with creatinine, cystatin-C, Beta-2-microglobulin, beta trace protein and combination of these with multiple validated equations
Time frame
Assessed at each study visit through study completion, up to 6 months.Sponsors and contacts
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Source ClinicalTrials.gov
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