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Extension Study in Primary Distal Renal Tubular Acidosis

NCT03831152 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2026-02-09

No results posted yet for this study

Summary

Open-label study involving longitudinal assessment of the continued safety, tolerability, and efficacy of ADV7103 in maintaining targeted serum bicarbonate levels, preventing metabolic acidosis, and preventing hypokalemia in the following groups of subjects with primary dRTA:

1. subjects who participated in Study B23CS and were adherent to the protocol;
2. subjects ≥ 6 months of age who are living in Europe and did not participate in Study B23CS; and
3. infants younger than 6 months of age

Conditions

  • Acidosis, Renal Tubular

Interventions

DRUG

ADV7103

Single group assignment

Sponsors & Collaborators

  • Advicenne Pharma

    lead INDUSTRY

Principal Investigators

  • Andre Ulmann, M.D., Ph.D. · Advicenne Pharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Months
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2025-01-31
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831152 on ClinicalTrials.gov