Trial · NCT04720326
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-normalised blood trough level of tacrolimus (concentration/dose ratio) | 12 weeks post-randomisation | To calculate C/D ratio, "concentration" is the blood trough level of tacrolimus measured in a blood sample collected immediately prior to drug dosing on the day of the 12-week trial visit and "dose" is the daily dose taken by the patient on the day prior to the visit. C/D ratio is measured as a surrogate for tacrolimus bioavailability (i.e. systemic exposure per mg of drug). |
| Secondary | Number of IMP dose adjustments | Until 12 weeks post-randomisation | |
| Secondary | Time to reach the first defined range in target trough level | Time period measured in days, assessed at 12 weeks post-randomisation | |
| Secondary | Number of measurements above and below the first defined range in target trough level | Time period measured in days, assessed at 12 weeks post-randomisation | |
| Secondary | Dose-normalised trough level (C/D ratio) during long-term follow-up | 1, 2 and 3 years post-randomisation | |
| Secondary | Mean tacrolimus trough level and inter-patient variability (range) of tacrolimus trough levels | 1, 2, 4 and 12 weeks post-randomisation | |
| Secondary | Inter-patient variability (range) of tacrolimus total daily dose | Until 12 weeks post-randomisation | |
| Secondary | Proportion of patients with trough levels lower, within, or higher than the standard reference range | 1, 2, 4 and 12 weeks post-randomisation | |
| Secondary | Incidence and severity of clinically-confirmed biopsy-proven acute rejection | 12 weeks and 1, 2, 3 years post-randomisation | |
| Secondary | Incidence of graft failure (defined as necessity for re-transplantation) | 12 weeks and 1, 2, 3 years post-randomisation | |
| Secondary | Incidence of death (for any reason) | 12 weeks and 1, 2, 3 years post-randomisation | |
| Secondary | Treatment failure rate (composite endpoint of biopsy-proven acute rejection, graft failure or death) | 12 weeks and 1, 2, 3 years post-randomisation | |
| Secondary | Time to treatment failure (composite endpoint of biopsy-proven acute rejection, graft failure or death) after randomisation | 3 years post-randomisation | |
| Secondary | Incidence of acute rejections requiring treatment | 12 weeks post-randomisation | |
| Secondary | Incidence of multiple rejection episodes | 12 weeks post-randomisation | |
| Secondary | Change versus baseline in laboratory measures of liver function (aspartate transaminase, alanine transaminase, alkaline phosphatase, gamma-glutamyltransferase, bilirubin, albumin, cholinesterase, INR) | 12 weeks and 1, 2, 3 years post-randomisation | |
| Secondary | Change versus baseline in laboratory measures of metabolic profile (triglycerides, HDL cholesterol, LDL cholesterol, total cholesterol, HbA1c, fasting plasma glucose) | 12 weeks and 1, 2, 3 years post-randomisation | |
| Secondary | Change versus baseline in laboratory measures of renal function (creatinine, estimated glomerular filtration rate) | 12 weeks and 1, 2, 3 years post-randomisation | |
| Secondary | Incidence and type of malignancies diagnosed in trial participants | 1, 2 and 3 years post-randomisation | |
| Secondary | Incidence and type of infections (hepatitis C virus, hepatitis B virus, cytomegalovirus, Epstein-Barr virus) experienced by trial participants | 1, 2 and 3 years post-randomisation |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04720326/registered