ADPKD Treatment Report

www.ADPKDTreatmentReport.com

Phase 3

A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients

https://clinicaltrials.gov/ct2/show/NCT03523728?type=Intr&cond=ADPKD&phase=01245&lupd_s=09%2F13%2F2020&lupd_d=1&sort=nwst

STUDY TITLE:
A Medical Research Study Designed to Determine if Venglustat Can be a Future Treatment for ADPKD Patients

STUDY DESCRIPTION:
Condition :   Polycystic Kidney, Autosomal Dominant

Interventions :   Drug: Venglustat GZ402671;   Drug: Placebo

Sponsor :   Genzyme, a Sanofi Company

Recruiting

CLINICALTRIALS.GOV ID:
NCT03523728

FIRST POSTED:
Mon, 14 May 2018 12:00:00 EDT

LAST UPDATE POSTED:
09/14/20 07:12AM

STUDY LINK:
https://clinicaltrials.gov/ct2/show/NCT03523728?type=Intr&cond=ADPKD&phase=01245&lupd_s=09%2F13%2F2020&lupd_d=1&sort=nwst

NOTES:

A Trial of Bardoxolone Methyl in Patients With ADPKD – FALCON (FALCON)

https://clinicaltrials.gov/ct2/show/NCT03918447

A Trial of Bardoxolone Methyl in Patients With ADPKD – FALCON (FALCON)

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Trial of Bardoxolone Methyl in Patients With Autosomal Dominant Polycystic Kidney Disease
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

https://clinicaltrials.gov/ct2/show/NCT04064346

Efficacy and Safety of Lixivaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized, placebo-controlled
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Sponsor
Primary Purpose: Treatment
Official Title: A 52-Week, Phase 3, Double-blind, Placebo-controlled, Randomized Study of the Efficacy and Safety of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024

Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)

https://clinicaltrials.gov/ct2/show/NCT02964273

Safety, Pharmacokinetics, Tolerability and Efficacy of Tolvaptan in Children and Adolescents With ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Study Type : Interventional (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3b, Two-part, Multicenter, One Year Randomized, Double-blind, Placebo-controlled Trial of the Safety, Pharmacokinetics, Tolerability, and Efficacy of Tolvaptan Followed by a Two Year Open-label Extension in Children and Adolescent Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Study Start Date : September 2016
Actual Primary Completion Date : December 2, 2019
Estimated Study Completion Date : December 2021