Study Evaluating Subjects With Distal Renal Tubular Acidosis

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2021
The study will target enrolling at least 4 subjects in each of the following age groups: 6 months ‐ 23 months; 2‐11 years, and ≥ 12 years. Subjects will be in the study for up to 21 weeks. After screening and enrollment, subjects will participate in an 8‐12 week open label period where there dose of ADV7103 will be titrated to effect, then continued for the remainder of the open‐label period. Periodic measurements of bicarbonate and potassium levels will be collected during this period. Following the open‐label period, subjects will enter a 6‐day randomized withdrawal period. A follow‐up period up to four weeks on re‐established therapy completes the trial. Subjects can elect to return to their previous standard of care regimen after completing the withdrawal period or will have the opportunity to subsequently enter an open‐label extension study.
Epistemonikos ID: a7137916700a3e76a7f22a8c7009e61ac5282f70
First added on: May 21, 2024