CKD trials are built on repeated creatinine and urine albumin results that become eGFR slope and UACR change. Capture calculates eGFR on the lab form, holds kidney outcome events in repeating rows and keeps every correction in one audit trail. Build and test free, no credit card.
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Central or local laboratory
Serum creatinine
CREATAge at visit
AGEFrom date of birth
63 CalculatedeGFR (CKD-EPI 2021)
EGFRDerived, read-only
45 mL/min/1.73 m² CalculatedUrine albumin-to-creatinine ratio
UACRUp 38% from baseline: confirm sample timing
Potassium
KAbove upper limit: query raised
What a CKD trial needs from its EDC
The study data
Kidney disease progresses slowly, so trials look for a signal in two ways. Outcome trials follow participants until enough composite events accrue, typically kidney failure, a sustained fall in eGFR, renal or cardiovascular death. Shorter trials of earlier-stage disease use surrogates: the rate of eGFR decline (slope) and the change in urine albumin. A 2018 workshop run by the National Kidney Foundation with FDA and EMA reviewed exactly this question and concluded that early UACR change and GFR slope can serve as surrogates under certain conditions, with stronger support for GFR change, while cautioning that each is only suitable in the settings where it performs well. Your statistical analysis plan decides which applies; the data-capture job is to make both analysable.
That puts weight on the humble lab form. A slope is only as good as the dates, the assay and the units behind every point. Capture builds the laboratory form as a table with an analyte per row, unit, result and reference range, and the lab results template shows the layout. Where your protocol relies on local laboratories, a lab unit converter for SI and conventional units helps sites that report creatinine in micromoles rather than milligrams, and range checks catch a value typed in the wrong unit before it reaches the analysis.
eGFR deserves special care. Capture can calculate eGFR using the CKD-EPI 2021 equation (the race-free version) and shows it read-only during entry, next to creatinine clearance by Cockcroft-Gault where a protocol dosing rule uses it. The free eGFR CKD-EPI calculator shows the inputs and the KDIGO categories. Using derived fields means a site cannot mistype a result, and when a creatinine is corrected the eGFR updates with a full audit trail entry for the change, including who changed it and why. For eligibility, an edit check can flag a screening eGFR outside the protocol range.
Kidney outcome events are rarely taken at face value. Many programmes send suspected events to an independent clinical events committee, which needs a source packet. Build an event form with repeating rows for each suspected event: type, onset date, whether dialysis or transplant followed, the supporting lab dates and the investigator's assessment. Each row carries its own audit trail. Capture records and exports the data; the adjudication process itself, and the committee charter, stay with the sponsor. For the adverse event side, see the adverse event template.
| Assessment | Screen | Day 1 | Wk 4 | Mo 3 | Mo 6 | Mo 12 | Every 6 mo |
|---|---|---|---|---|---|---|---|
| Creatinine, eGFR (derived) | |||||||
| UACR (first morning void) | |||||||
| Potassium and safety chemistry | |||||||
| Blood pressure, weight | |||||||
| Event review (kidney, CV) | |||||||
| Kidney-disease QoL questionnaire |
x = form completed at this visit
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility | Screening eGFR and UACR ranges, diabetes status, background therapy | Eligibility screening template with range edit checks |
| Kidney function series | Creatinine, derived eGFR, assay and date at each visit | Laboratory template with calculated eGFR (CKD-EPI 2021) |
| Albuminuria | UACR with sample type and collection timing | Numeric lab rows plus a sample-type field |
| Blood pressure and weight | Seated office BP, derived MAP, weight | Vital signs template |
| Concomitant medicines | RAS inhibitors, SGLT2 inhibitors, diuretics, dose changes | Concomitant medications template with repeating rows |
| Outcome events | Suspected kidney or CV event, dates, dialysis, source documents | Repeating event form for the adjudication hand-off |
| Patient-reported outcome | Quality of life, fatigue | EQ-5D or FACIT-Fatigue layouts; licences stay with your study documents |
| Adverse events | Hyperkalaemia, acute kidney injury, genital infection | Adverse event form with seriousness and sign-off |
Capture does not supply licensed instruments or verify licences. Licence controls exist only on participant questionnaires.
Build the lab form, trigger every check with sample data and show your steering committee the working study. Free sandbox, no credit card.
Safety and population
People with CKD usually also have diabetes, hypertension or heart disease, so the medicine list is long and the adverse event profile is wide. Potassium and creatinine surveillance after starting a renin-angiotensin or mineralocorticoid-receptor drug is the textbook example: a protocol may require a repeat sample within weeks and a dose rule above a threshold. Build those as visit forms with range edit checks. An edit check is a data-management prompt that makes a signal visible and raises a query; it does not replace the investigator's safety procedure, and your protocol should say so.
Blood pressure is both a safety measure and a covariate. The hypertension trial page goes deeper on office, home and ambulatory capture; for CKD, a seated office reading with derived mean arterial pressure on the vital-signs form is the usual minimum. Heart failure overlaps too, and pooled cardiorenal programmes often need a shared event dictionary across both indications.
Dialysis and transplant studies share some data but ask different questions: session-level data, access complications, graft function. The same building blocks apply, with the dialysis session or transplant as a repeating row, but the visit rhythm and endpoint differ enough that you should build them as separate studies or separate epochs rather than one form set.
Build sequence
A practical order of work for a sponsor, an investigator team or a nephrology research group.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the visit schedule and forms. Nothing is saved until a person reviews it.
Decide whether creatinine and UACR come from a central or local laboratory and set the units and reference ranges per row.
Switch on the derived eGFR, set eligibility and safety ranges for creatinine, potassium and BP.
Create the repeating suspected-event form and agree the source-document list with your adjudication committee.
Enter practice participants through two years of visits, break every rule, and read the audit trail of a corrected creatinine.
Forms move from draft to approved and approved forms lock for live use. Real participants start the paid live phase.
Before first participant
CKD-EPI 2021 or the equation named in the protocol, with sex and age inputs confirmed.
First morning void or timed sample, repeat-sample rule, and where each is recorded.
Kidney failure, sustained decline and dialysis defined identically in the protocol and the form.
Local laboratories report in the same units, or a conversion is documented.
Potassium, creatinine and BP edit checks, with a named person responsible for each query.
CSV or Excel with the data dictionary opened in the statistics package; SDTM export checked if required.
Yes. eGFR by the CKD-EPI 2021 equation is one of the derived fields Capture can calculate and show read-only on the form from creatinine, age and sex. Creatinine clearance by Cockcroft-Gault is also available for protocols that use it.
Capture records each eGFR value with its date, and the dated series is exported for the statistician to fit the slope. The slope model itself belongs to your analysis plan, not the EDC.
Yes. Build an event form with repeating rows for type, onset, dialysis or transplant and supporting dates. Each row has its own audit trail and exports with the rest of the data. Adjudication itself is a sponsor process outside Capture.
This page makes no claim about laboratory integrations. Sites or data managers enter or load results; ask about your central lab file format before you commit to a design.
Yes, with the dialysis session or graft assessment as repeating rows. Build them as a separate study or separate epochs from an early-stage CKD design, because the visit rhythm and endpoints differ.
Yes. Capture is suitable for Phase 1, 2 and 3 studies, with site-level numbering, a site coordinator portal, by-site filtering and exports for multi-site work.
The sandbox is free with every feature, no credit card and no time limit. You pay only once you go live with real participants. Pricing is not published on the site, so ask for terms for your study.
Keep exploring
eGFR CKD-EPI calculator
The equation and KDIGO categories.
Laboratory eCRF template
Analyte rows with units and ranges.
EDC for hypertension trials
Office, home and ambulatory BP.
Lab unit converter
SI and conventional units.
EDC for Phase 3 trials
Large multi-site programmes.
Pricing
Free sandbox, pay at go-live.
Free sandbox with every feature. No credit card, and you pay only when you go live.