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Trial · NCT07884084

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryChanges in immunosuppressant drug blood levels
Immunosuppressant blood levels will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Cyclosporin A, tacrolimus and sirolimus will be measured using CMIA (Chemiluminescent Microparticle Immunoassay); everolimus using QMS (Quantitative Microsphere System); mycophenolic acid using CEDIA (Cloned Enzyme Donor Immunoassay); and prednisolone using ELISA (Enzyme-Linked Immunosorbent Assay).
SecondaryChanges in the blood levels of high-sensitivity C-reactive protein (hsCRP)
High-sensitivity C-reactive protein (hsCRP) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
High-sensitivity C-reactive protein (hsCRP) will be measured in mg/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
SecondaryChanges in the blood levels of interleukin-1β (IL-1β)
Interleukin-1β (IL-1β) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Interleukin-1β (IL-1β) will be measured in ng/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
SecondaryChanges in the blood levels of interleukin-6 (IL-6)
Interleukin-1β (IL-1β) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Interleukin-6 (IL-6) will be measured in ng/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
SecondaryChanges in the blood levels of tumor necrosis factor-α (TNF-α)
Tumor necrosis factor-α (TNF-α) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Tumor necrosis factor-α (TNF-α) will be measured in ng/L using ELISA (Enzyme-Linked ImmunoSorbent Assay).
SecondaryChanges in the blood urea nitrogen (BUN)BUN will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.Blood urea nitrogen (BUN) will be measured in mg/dL using a standard clinical chemistry analyzer.
SecondaryChanges in serum creatinine
Serum creatinine will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Serum creatinine will be measured in mg/dL using a standard clinical chemistry analyzer.
SecondaryChanges in Estimated Glomerular Filtration Rate (eGFR)eGFR will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.eGFR will be measured in ml/min using a standard clinical chemistry analyzer.
SecondaryBody weight
Body weight will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period
Body weight in Kg will be measured using a professional medical scale.
SecondaryBody Mass Index (BMI)
Body Mass Index (BMI) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Body Mass Index (BMI) will be calculated as the ratio of body weight to the square of height.
SecondaryWaist circumference
Waist circumference will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Waist circumference in cm will be measured using a tape measure.
SecondaryTotal body water
Total body water will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Total body water in Liters will be measured using Bioelectrical Impedance Analysis (BIA).
SecondaryExtracellular water
Extracellular water will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Extracellular water in Liters will be measured using Bioelectrical Impedance Analysis (BIA).
SecondaryFat Mass (FM)
Fat Mass (FM) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Fat Mass (FM) in Kg will be measured using Bioelectrical Impedance Analysis (BIA).
SecondaryFat Free Mass (FFM)
Fat Free Mass (FFM) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Fat Free Mass (FFM) in Kg will be measured using Bioelectrical Impedance Analysis (BIA).
SecondaryPhase Angle (PhA)
Phase Angle (PhA) will be measured at the following time points: • Day 0: baseline • Day 30: end of the first treatment period • Day 60: end of the washout period • Day 90: end of the second treatment period.
Phase Angle (PhA) will be calculated using the resistance and reactance values measured with BIA.

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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