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Detection of Kidney Transplant Medication Toxicity

Detecting Kidney Transplant Calcineurin Inhibitor Toxicity (the TransTox Study) in adult patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624001205527
Acronym
TransTox
Enrollment
66
Registered
2024-10-01
Start date
2022-09-16
Completion date
2024-09-30
Last updated
2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is an observational study to discover and assess new markers in the blood or urine that detect early stages of kidney damage from the toxic effects of transplant anti-rejection medications (tacrolimus). Patients undergoing kidney transplantation with no prior exposure to tacrolimus are enrolled and daily blood and urine samples are collected for the first 30 days after the transplant. The hypothesis is that we can better detect kidney toxicity caused by tacrolimus by using the new biomarkers studied here than by the standard clinical measurement of serum creatinine. This will allow our team to develop better protocols to determine tacrolimus dosage in clinical care within the first 30 days after kidney transplantation.

Interventions

Kidney transplantation and exposure to tacrolimus. This study involves daily blood and urine sample collection of patients undergoing kidney transplantation, from one day before the transplant up to 30 days after (or earlier, if patient is discharged from the study hospital before postoperative day 30). Medical record information is also gathered, including daily tacrolimus dosage and blood levels, potential episodes of AKI after transplant and causes, such as rejection, infections or surgical c

Kidney transplantation and exposure to tacrolimus. This study involves daily blood and urine sample collection of patients undergoing kidney transplantation, from one day before the transplant up to 30 days after (or earlier, if patient is discharged from the study hospital before postoperative day 30). Medical record information is also gathered, including daily tacrolimus dosage and blood levels, potential episodes of AKI after transplant and causes, such as rejection, infections or surgical complications, kidney biopsy results, long-term kidney function and damage, as measured by serum creatinine and urine albuminuria. The overall duration of observation is from time of enrolment for 12 months.

Sponsors

Professor Zoltan Endre, Nephrology Department at Prince of Wales Hospital
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients undergoing kidney transplantation with no prior exposure to tacrolimus.

Exclusion criteria

age < 18 yo; non-consent transplant cancelled

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026