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Trial · NCT05744635

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPharmacokinetic profile TL12 monthsTo compare the trough level (TL) of different tacrolimus containing medications to Envarsus at each visit
PrimaryPharmacokinetic profile TDD12 monthsTo compare the total daily dose (TDD) of different tacrolimus containing medications to Envarsus at each visit
PrimaryPharmacokinetic profile C/D12 monthsTo compare the ration of TL and TDD (C/D) of different tacrolimus containing medications to Envarsus at each visit
SecondaryLiver function GGT12 monthsChanges in Gamma glutamine transferase (GGT) levels compared to baseline.
SecondaryLiver function AP12 monthsChanges in Alcalic phosphatase (AP) levels compared to baseline.
SecondaryLiver function GOT12 monthsChanges in Glutamyl oxaloacetic transaminase (GOT) levels compared to baseline.
SecondaryLiver function GPT12 monthsChanges in Glutamyl pyruvic transaminase (GPT) levels compared to baseline.
SecondaryRenal function12 monthsChange in the estimated glomerular filtration rate (eGFR) compared to baseline.
SecondaryKinetics and function12 monthsTo assess the possible relation of liver function parameters and eGFR to C/D (blood concentration and daily dosage)
SecondaryRejection12 monthsIncidence of acute graft rejection during the study
SecondaryVirus infection12 monthsIncidence of BK and cytomegalovirus (CMV) infection during the study
SecondaryVariability12 monthsTo assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C/D)
SecondaryAdherence BAASIS12 monthsTo assess the patient-adherence of therapy based on the BAASIS questionnaire
SecondaryAdherence prescriptions12 monthsTo assess the patient-adherence of therapy based on the prescription filled by individual patients, based on electronic health-care record.

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.

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