Study Evaluating Subjects With Distal Renal Tubular Acidosis

PHASE3TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

September 20, 2021

Primary Completion Date

December 20, 2023

Study Completion Date

December 20, 2023

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."

Trial Locations (8)

10467

Montefiore Medical Center, The Bronx

19104

The Children's Hospital of Philadelphia, Philadelphia

30322

Emory Children's Center, Atlanta

33606

University of South Florida Pediatric Infectious Disease, Tampa

46202

J.W. Riley Hospital for Children/Indiana University, Indianapolis

80045

Children's Hospital Colorado, Aurora

T6G 2R3

University of Alberta, Edmonton

M5G 1X8

The Hospital for Sick Children, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Advicenne Pharma

INDUSTRY