Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
Primary Objectives:
Secondary Objectives:
Full description
The planned length of participation in the study for each participant was up to approximately 110 weeks (from screening through completion of follow-up). This included:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female.
Confirmed diagnosis of Alport syndrome
Age 18-55 years old.
eGFR > 35 ml/min/1.73m^2 and <90 mL/min/1.73m^2 (based on CKD-EPI) at screening.
Renal Function Criteria (participants must have met at least one of the following CRITERIA A, B or C):
ACE inhibitor and/or ARB, the dosing regimen should be stable for at least 30 days prior to screening.
Sexually active female participants of childbearing potential and sexually mature male participants must have agreed to practice true abstinence in line with their preferred and usual lifestyle or to use two acceptable effective methods of contraception for the entire duration of the study and for at least 6 weeks after last dose.
Negative drug screen for opiates, cocaine, heroin, phencyclidine, amphetamines (including ecstasy), barbiturates, benzodiazepines, and cannabinoids. At the Investigator's discretion, participants prescribed benzodiazepines, cannabinoids, or opiates with positive results on a drug screen were allowed.
Negative screening results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, and human immunodeficiency virus (HIV) antibody.
Normal biological tests.
Able to understand all study procedures in the informed consent form (ICF) and to comply with all aspects of the protocol.
Exclusion criteria
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
43 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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