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Study Evaluating Subjects With Distal Renal Tubular Acidosis

NCT03644706 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2024-03-22

No results posted yet for this study

Summary

This is a phase 3, prospective, multicenter, randomized, double-blinded, placebo-controlled withdrawal study comparing the efficacy of ADV7103 versus placebo in preventing the development of metabolic acidosis defined by serum bicarbonate levels in pediatric (6 months to \< 18 years of age) and adult (18 to 65 years of age) subjects with primary Distal Renal Tubular Acidosis (dRTA).

Conditions

  • Distal Renal Tubular Acidosis

Interventions

DRUG

ADV7103

Each dose of ADV7103 contains a fixed ratio of 1/3 of ADV7103-CK (potassium citrate) and 2/3 of ADV7103-BK (potassium bicarbonate) based on the mass of active substances. The strength is 6.44 (± 10 %) mEq/g of ADV7103 (alkalinizing power).

DRUG

Placebo

Placebo is a combination of 2 mm green coated lactose granules and 2 mm white coated lactose granules to be taken by mouth. Each dose of placebo contains a fixed ratio of 1/3 of green granules and 2/3 of white granules.

Sponsors & Collaborators

  • Advicenne Pharma

    lead INDUSTRY

Principal Investigators

  • Laurence Greenbaum, MD, Ph.D. · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2023-12-20
Completion
2023-12-20
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT03644706 on ClinicalTrials.gov