Abstract | BACKGROUND: TRIAL DESIGN: A double blinded randomized trial. METHODS: The anti-proteinuric effect of tacrolimus was explored for 40 biopsy-proven mild IgA nephropathies for 16 weeks. We randomly assigned patients either to receive tacrolimus or placebo with stratification by using a renin angiotensin system blocker. The primary outcome was the percentage change of final UACR compared to the baseline value (pcUACR). RESULTS: The mean value of pcUACR at 12-week and 16-week visits (primary outcome) was decreased more in the Tac group compared to the control group (-52.0±26.4 vs -17.3±29.3%, p = 0.001). At each visit, pcUACR was also decreased more in the Tac group compared to the control group. In the Tac group, the pcUACRs were -60.2±28.2%, -62.2±33.9%, -48.5±29.8%, and -55.5±24.0%, and, in the control group, -6.8±32.2%, -2.5±35.9%, -12.7±34.2%, and -21.9±30.6%, at 4-week, 8-week, 12-week, and 16-week visits, respectively. The pre-defined secondary outcomes were better in the Tac group compared to the control group. The frequency of decrease in pcUACR and percentage change of UPCR (pcUPCR) ≥50% at 16 weeks were 65.0% (13/20) and 55.0% (11/20)in the Tac group, and 25.0% (5/20) and 15.0% (3/20), in the control group, respectively (p = 0.025 for pcUACR and p = 0.019 for pcUPCR). However, tacrolimus wasn't effective with a dose of 0.05 mg/kg/day in patients taking ARB. The adverse events were tolerable. CONCLUSION: TRIAL REGISTRATION: Clinicaltrial.gov NCT1224028.
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Authors | Yong-Chul Kim, Ho Jun Chin, Ho Suk Koo, Suhnggwon Kim |
Journal | PloS one
(PLoS One)
Vol. 8
Issue 8
Pg. e71545
( 2013)
ISSN: 1932-6203 [Electronic] United States |
PMID | 23977072
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Angiotensin II Type 1 Receptor Blockers
- Creatinine
- Tacrolimus
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Topics |
- Adult
- Albuminuria
(complications, drug therapy, physiopathology, urine)
- Angiotensin II Type 1 Receptor Blockers
(pharmacology, therapeutic use)
- Blood Pressure
(drug effects)
- Creatinine
(blood, urine)
- Double-Blind Method
- Female
- Follow-Up Studies
- Glomerular Filtration Rate
- Glomerulonephritis, IGA
(complications, drug therapy, physiopathology, urine)
- Humans
- Male
- Tacrolimus
(adverse effects, pharmacology, therapeutic use)
- Treatment Outcome
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