Safety and Efficacy of the ACE-Inhibitor Ramipril in Alport Syndrome: The Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III EARLY PRO-TECT Alport Trial in Pediatric Patients
Table 3
Patient eligibility criteria.
Inclusion criteria
(i) Males or females of any ethnic origin aged between 24 months and <18 years at screening. Female patients of child-bearing potential test negative for pregnancy test and agree to use a reliable method of birth control during the study.
(ii) Definitive diagnosis of Alport syndrome by kidney biopsy (in patient or other affected family members) and/or genetic testing (hemizygous males with X chromosomal Alport syndrome or homozygous males or females with autosomal recessive Alport syndrome) including screening for clinical diagnostic criteria (hematuria, family history of kidney disease, hearing loss, ocular changes).
(iii) Alport syndrome stages 0 or I.
(iv) Previously untreated with ACEIs (patients taking an ACEI for the treatment of Alport syndrome may be included in the open-label treatment arm).
(v) Written informed consent.
Exclusion criteria
(i) Uncertain diagnosis or variants of Alport syndrome such as heterozygous carriers.
(ii) Alport syndrome stages II, III, or IV.
(iii) Known allergies or intolerances to ramipril or related compounds.
(iv) Known contraindication for ACEI therapy (e.g., bilateral renal artery stenosis, prior history of angioedema, previous hyperkalemia, or previous acute prerenal renal failure).
(v) Females with a positive pregnancy test or females who are lactating.
(vi) Additional other chronic renal, liver, or cardiac diseases.
