A Phase 2 interventional study of Tacrolimus and Placebo in IgA Nephropathy, sponsored by Astellas Pharma Inc. Completed at 1 site in South Korea. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-08-21.
Sponsored by Astellas Pharma Inc · Phase 2, Interventional, and Treatment
This study is to evaluate efficacy and safety of tacrolimus in the patients with non-nephrotic albuminuric, normotensive IgA nephropathy after 16 week treatment with tacrolimus (Prograf) or placebo.
262 studies on the registry are indexed under Glomerulonephritis, IGA; 102 are open to participants now.
This study's enrollment of 40 is below the median of 68 across 212 interventional studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →Astellas Pharma Inc is the lead sponsor of 525 studies on the registry; 4 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 19 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Tacrolimus
Drug: Placebo
oral
Also known as: Prograf, FK506
oral
Percent change from baseline UACR to mean value of UACR measured on week 12 and week 16 (UACR: Urine Albumin Creatinine Ratio)
Time frame: Week 0, week 12 and week 16
Proportion of subjects achieving more than 30% reduction of UACR level from baseline
Time frame: Week 0 and week 16
Proportion of subjects achieving more than 50% reduction of UACR level from baseline
Time frame: Week 0 and week 16
Proportion of subjects achieving more than 0.2 reduction of UACR level
Time frame: Week 0 and week 16
Composite event rate achieving less than 0.2 or 50% reduction of UACR level
Time frame: Week 0 and week 16
Changes of UACR measured between before the study and each visit
Time frame: Week 0, week 4, week 8, week 12 and week 16
Incidence of adverse events according to subject's self-assessment, vital signs, investigator's assessment and labo-tests
Time frame: Through week 16
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tacrolimus