EUCTR2010-024300-10-DE
Active, not recruiting
Phase 1
Early prospective therapy trial to delay renal failure in children with Alport syndrome. - EARLY PRO-TECT Alport
niversity Medical Center Göttingen0 sites66 target enrollmentDecember 12, 2011
ConditionsAlport's syndromeMedDRA version: 19.1Level: PTClassification code 10001843Term: Alport's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
DrugsDelix
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Alport's syndrome
- Sponsor
- niversity Medical Center Göttingen
- Enrollment
- 66
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
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, I or II at screening (microhaematuria without microalbuminuria or microalbuminuria \[30\-300 mg albumin/gCrea]) or proteinuria \>300 mg albumin/gCrea with GFR\>80ml/min). Patients with Alport stage II are not subject to randomization but are treated opel label.
- •\- Aged between \=24 months and \<18 years at screening
- •\- Assent from patient and informed consent from parents/legal guardian
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\- Uncertain diagnosis or variants of Alport syndrome such as a heterozygous carrier
- •\- Alport syndrome levels III, or IV (creatinine clearance \<80 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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