Status:
COMPLETED
Efficacy and Safety Study to Delay Renal Failure in Children With Alport Syndrome
Lead Sponsor:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborating Sponsors:
University Medical Center Goettingen
German Federal Ministry of Education and Research
Conditions:
Renal Insufficiency, Chronic
Eligibility:
All Genders
24-18 years
Phase:
PHASE3
Brief Summary
This is a phase III, multi-centre, randomised, placebo-controlled, patient and investigator-blind study in paediatric patients with early stages of Alport syndrome to assess the safety and efficacy of...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Uncertain diagnosis or variants of Alport syndrome such as a heterozygous carrier
- Alport syndrome levels 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01485978
Start Date
March 1 2012
End Date
March 1 2019
Last Update
June 17 2020
Active Locations (1)
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1
University Medical Center Goettingen
Göttingen, Germany, 37075