NCT04147871 - Study Evaluating Patients With Cystinuria and Efficacy and Safety Exploratory Study in the Youngest Children | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 1, 2024

Primary Completion Date

May 1, 2025

Study Completion Date

June 1, 2025

Conditions

Cystinuria

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.

DRUG

Placebo

"Placebo is a combination of 2 mm green coated lactose granules and 2 mm white coated lactose granules.~Each dose of placebo contains a fixed ratio of 1/3 of green granules and 2/3 of white granules."

Trial Locations (12)

15013

CHU Pitié-Salpétrière, Paris

31059

CHU Purpan, Toulouse

38043

CHU Grenoble, Grenoble

51092

Hôpital Américain CHU de Reims, Reims

51100

CHU Reims, Reims

59000

CHRU Lille, Lille

69500

Centre Hospitalier Universitaire de Lyon - Hôpital Femme Mère Enfant, Bron

75015

Hôpital Necker AP-HP, Paris

Hôpital Necker Enfants Malades, Paris

75020

Hôpital Ténon - Explorations fonctionnelles Mutlidisciplinaires et INSERM UMR S 1155, Paris

Unknown

Cliniques Universitaires Saint-Luc, Brussels

UZ Leuven, Gasthuisberg Hospital, Leuven