Alport's syndrome MedDRA version: 19.1 Level: PT Classification code 10001843 Term: Alport's syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Interventions
Trade Name: Delix
Product Name: Delix
Pharmaceutical Form: Tablet
CAS Number: 87333-19-5
Other descriptive name: RAMIPRIL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
University Medical Center Göttingen
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if the treatment of Alport's syndrome with the ACE inhibitor ramipril from early stages of disease is safe and significantly slows disease progression to renal failure.;Secondary Objective: ;Primary end point(s): Primary Efficacy Endpoint: Time to progression of Alport Syndrome to the next disease level under ramipril treatment compared to placebo, for all randomised patients. Primary Safety Endpoint: Incidence of adverse drug events (ADEs, e.g., angioedema, acute renal failure, hyperkalaemia) under ramipril treatment before disease progression compared to placebo before disease progression, for all randomised patients. ;Timepoint(s) of evaluation of this end point: Primary Efficacy Endpoint: within up to 6 years, until disease progression Primary Safety Endpoint: within up to 6 years, until disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoint: Albuminuria after end of treatment corrected for baseline albuminuria for patients randomised to receive ramipril compared to placebo. Secondary Safety Endpoint: Incidence of ADEs (e.g., angioedema, acute renal failure, hyperkalaemia) during treatment for patients randomised to receive ramipril compared to placebo. ;Timepoint(s) of evaluation of this end point: Secondary Efficacy Endpoint: after up to 6 years Secondary Safety Endpoint: after up to 6 years | — |
Countries
Germany
Contacts
Public ContactAbt. Nephrologie und Rheumatologie
University Medical Center Goettingen
Outcome results
None listed