Transplant trials follow a participant from surgery through rejection episodes, drug level adjustments and infections, often for years. Capture structures transplant, biopsy, lab and event data in one study, with kidney function calculated as sites enter data.
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Serum creatinine
CREATeGFR (CKD-EPI 2021)
EGFRTacrolimus trough
TACTRGHWithin protocol target range
What matters in transplant trials
Study design
The weeks after transplantation involve frequent visits, drug level checks and dose adjustments, with rejection episodes most likely in the first months. After that, visits space out but follow-up often continues for years, because graft survival is the outcome that matters most to patients. The study needs a schedule that handles both: dense early visits with windows, and long-term follow-up that keeps participants engaged.
Transplant data also includes the transplant itself: donor type and characteristics, ischaemia times, HLA mismatches and induction therapy. These baseline factors strongly influence outcomes and are often stratification factors, so they need to be structured and verified early.
Haematopoietic stem cell transplant trials have different endpoints: engraftment, graft-versus-host disease graded by standard criteria, relapse and non-relapse mortality. See EDC for hematology trials.
| Assessment | Tx | D7 | W2 | M1 | M3 | M6 | M12 |
|---|---|---|---|---|---|---|---|
| Renal function and eGFR | |||||||
| Trough levels | |||||||
| Protocol biopsy | |||||||
| Viral monitoring (CMV, BK) | |||||||
| Donor-specific antibodies |
Plus for-cause biopsies and unscheduled visits
Kidney function
Calculated fields show eGFR (CKD-EPI 2021) and creatinine clearance (Cockcroft-Gault) read-only during entry, so the site sees kidney function immediately. Trough levels are recorded as repeating rows with dates and times, each row with its own audit trail, and range checks raise queries when values fall outside the limits you set.
BMI (Body Mass Index)
Auto-derivedHeight (cm)
172
Weight (kg)
68.5
Result
23.2 kg/m²
Reference: WHO · shown read-only during data entry
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Endpoints
| Endpoint | Data needed |
|---|---|
| Efficacy failure composite | Biopsy-proven acute rejection, graft loss, death, loss to follow-up, with dates |
| Biopsy-proven acute rejection | Biopsy date, indication, Banff grade, central read if used, treatment |
| Graft function | Creatinine, eGFR, proteinuria over time |
| Graft and patient survival | Graft loss and death with causes, long-term follow-up |
| Infections | CMV and BK monitoring, infection events and treatment |
| Immunological risk | HLA mismatches, donor-specific antibodies |
Safety
Every transplant trial balances two risks: too little immunosuppression leads to rejection, too much leads to infections, malignancy and drug toxicity. Safety data therefore includes infections, new-onset diabetes after transplantation, kidney toxicity from calcineurin inhibitors, and cancers over long follow-up. Structured adverse event forms with the minimum dataset enforced, and serious events routed for review, keep that data consistent.
Concomitant medications matter too: many drugs interact with immunosuppressants and change trough levels. Record them on the concomitant medications form with start and stop dates.
Study build
Donor type, ischaemia times, HLA mismatches, induction.
Components and time point in the analysis plan.
Indication, Banff grading and central review fields.
Repeating rows with dates, times and dose changes.
CMV and BK schedules and event forms.
Graft survival and safety beyond the primary time point.
Donor type, ischaemia times, HLA mismatches and induction therapy influence outcomes and are often stratification factors.
The primary endpoint is often at 12 months, with graft and patient survival followed for years.
Commonly a composite efficacy failure endpoint of biopsy-proven acute rejection, graft loss, death or loss to follow-up, often at 12 months.
Yes. eGFR (CKD-EPI 2021) and creatinine clearance (Cockcroft-Gault) are calculated fields shown read-only during entry.
As repeating rows with dates, times and values, each row with its own audit trail.
Usually with the Banff classification on biopsy, often with central pathology review.
Yes. Engraftment, GVHD, relapse and survival data can be structured in the same way.
Yes, in the free sandbox with every feature.
Keep exploring
Calculated eGFR, trough logs and biopsy forms. Free sandbox.