EXACT Study: A Blinded Study in Patients With Alport Syndrome to Evaluate Exaluren Efficacy and Safety
Recruiting
Phase 2
Interventional Study
Alport Syndrome, X-Linked
Alport Syndrome, Autosomal Recessive
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- Eloxx Pharmaceuticals, Inc. · Industry
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About This Trial
This is a randomized, double-Blind, placebo-controlled study to evaluate the efficacy and safety of exaluren in Alport Syndrome patients with nonsense mutations in COL4A3/4/5 genes.
Targeted 24 patients aged 12 and older will be enrolled in the trial.
The study will be comprised of the following periods for each participant:
* a Screening period of up to 6 weeks (42 days)
* a total Treatment Pe…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* A confirmed diagnosis of X-linked or autosomal recessive Alport Syndrome with a documented nonsense mutation of COL4A5 in a male or nonsense mutation of COL4A3 or COL4A4 (male or female)
* eGFR\>45 ml/min/1.73 m2
* Urinary protein based on two spot urine collections \[urine pr…
Contacts
No contact information available.