DRKS00003624
Recruiting
Phase 3
Early Prospective Therapy Trial to Delay Renal Failure in Children with Alport Syndrome - EARLY PRO-TECT Alport
niversitätsmedizin Göttingen0 sites120 target enrollmentMarch 23, 2012
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- MedDRA - 10001843 (Alport`s syndrome)
- Sponsor
- niversitätsmedizin Göttingen
- Enrollment
- 120
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Definitive diagnosis of Alport syndrome: Kidney biopsy (patient or affected relative/s), and/or mutation analysis (hemizygous X\-chromosomal or homozygous autosomal\-recessive) and assessment of criteria for clinical diagnosis (haematuria, positive family history regarding kidney diseases, ocular changes, labyrinthine hearing loss)
- •\- Alport syndrome levels 0 or I at screening (microhaematuria without microalbuminuria or microalbuminuria \[30\-300 mg albumin/gCrea]).
- •\- Aged between \=24 months and \<18 years at screening
- •\- Assent from patient and informed consent from parents/legal guardian
Exclusion Criteria
- •\- Uncertain diagnosis or variants of Alport syndrome such as a heterozygous carrier
- •\- Alport syndrome levels II, , III, or IV (albuminuria \>300 mg/g Crea, creatinine clearance \<60 mL/min, or end stage renal failure \[ESRF])
- •\- Known allergies or intolerances to ramipril or related compounds
- •\- Known contraindication for ACEi\-therapy
- •\- Additional chronic renal, pulmonary or cardiac diseases
- •\- Pregnancy and lactation
Outcomes
Primary Outcomes
Not specified
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