A Phase 2 interventional study of Atrasentan low dose group and Atrasentan high dose group in Chronic Kidney Disease and Diabetic Nephropathy, sponsored by AbbVie (prior sponsor, Abbott). Completed at 18 sites in Japan. Open to participants aged 20 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by AbbVie (prior sponsor, Abbott) · Phase 2, Interventional, and Treatment
Prospective, randomized, double-blind, placebo controlled, 12-week, multicenter study. The objective of the study is to evaluate the efficacy and safety of once daily administration of atrasentan tablets compared to placebo in reducing residual albuminuria in Japanese Type 2 diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose for hypertension of a RAS (renin angiotensin system) inhibitor.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 58 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Atrasentan low dose group
Drug: Atrasentan high dose group
Drug: Atrasentan placebo group
Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.
Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.
Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.
The change from baseline to each post-baseline visit in log-transformed UACR (urinary albumin to creatinine ratio)
Time frame: Up to Week 12
The proportion of subjects who have achieved at least 30% reduction on UACR (Urinary Albumin to Creatinine Ratio) who have not had any form of treatment-emergent edema with moderate or severe severity.
Time frame: Up to Week 12
The change from baseline to each post-baseline visit on log-transformed UACR (Urinary Albumin to Creatinine Ratio) and estimated GFR (Glomerular Filtration Rate)
Time frame: Up to Week 12
The proportion of subjects who achieve various percent of reduction in UACR (Urinary Albumin to Creatinine Ratio) from baseline to final
Time frame: Up to Week 12
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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AbbVie (prior sponsor, Abbott)