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Trial · NCT03129126

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryPatient Reported Mean episodes of visible bloodAt every patient visit, up to 2 weeks following initial treatmentPre-post changes in mean episodes of visible blood in urine (or blood clots) on 3-day bladder diaries at baseline and primary endpoint
SecondaryUrine Dipstick Mean episodes of Visible BloodAt every patient visit, up to 2 weeks following initial treatmentMean episodes of visible blood in urine (or blood clots) and urine dipstick for quantitative grading of microscopic hematuria on bladder diaries
SecondaryMean urine hemoglobin concentrationAt every patient visit, up to 2 weeks following initial treatmentMean urine hemoglobin concentration
SecondaryUrine analysis with microscopyAt every patient visit, up to 2 weeks following initial treatmentUrine analysis with microscopy including red blood cells per high power field test
SecondaryWhole blood Add to dictionary levelsAt every patient visit, up to 2 weeks following initial treatmentWhole blood tacrolimus levels
SecondaryBlood chemistry and liver function testAt every patient visit, up to 2 weeks following initial treatmentBlood chemistry and liver function test
SecondaryPatient Reported Global Response Assessment Survey ScoreAt every patient visit, up to 2 weeks following initial treatmentChanges in Global Response Assessment (GRA)
SecondaryPatient Reported Urinary frequencyAt every patient visit, up to 2 weeks following initial treatmentChanges in urinary frequency and incontinence measured on diaries
SecondaryBladder CystoscopyAt initial treatment and on final patient visit, up to 2 weeks following initial treatmentCystoscopic changes in bladder
SecondaryPatient Reported Health Related Quality of Life Survey ScoreAt every patient visit, up to 2 weeks following initial treatmentChanges in Health Related Quality of Life (HRQOL) scores
SecondaryPost void residual urine volumeAt every patient visit, up to 2 weeks following initial treatmentPost void residual urine volume
SecondaryPatient Reported Pain and UrgencyAt every patient visit, up to 2 weeks following initial treatmentChange in pain and urgency 10 cm visual analog scales (VAS)
SecondaryIncidence of Treatment-Emergent Adverse EventsAt every patient visit, up to 2 weeks following initial treatment
Safety data will be collected by ongoing monitoring of adverse events, during the entire duration of the study, including need for blood transfusion, bladder irrigation, emergency room visit, hospitalization, urinary catheterization, and/or surgery in addition to patient reporting of changes in urinary frequency, hematuria/ clots, incontinence, spasm or discomfort.

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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