EUCTR2019-001440-22-SE
Active, not recruiting
Phase 1
Phase 2, multicenter, randomized, open-label, controlled, 2-arm cross-over study to evaluate the clinical efficacy and safety of a renin inhibitor, aliskiren, compared to an angiotensin converting enzyme inhibitor, enalapril, in children and adults with C3 glomerulopathy - Reninblock-C3G
Skåne University Hospital0 sites30 target enrollmentMarch 21, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- C3 glomerulopathy
- Sponsor
- Skåne University Hospital
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Children \= 6 years and adults.
- •2\. Initial diagnosis of Dense Deposit Disease and C3 glomerulonephritis confirmed by kidney biopsy obtained not more than 2 years before the first dose of the study drug.
- •3\. Either absence of treatment at the study start or ongoing treatment with aliskiren, ACEi, ARBs or immune suppressive medications (such as mycophenolate mofetil/MMF or corticosteroids)
- •4\. Written informed consent has been given by:
- •a. the patient’s legal guardians if the patient is less than 15 years old
- •b. the patient and his/her legal guardians if the patient is \= 15 but \< 18years old
- •c. the patient if the patient is \= 18 years old
- •5\. Female subjects of childbearing potential must:
- •a. Understand that the study medication is expected to have a teratogenic risk
- •b. Agree to use a highly effective contraception during study drug therapy. This applies unless the subject is less than 18 years of age, has not had sexual debut and commits to sexual abstinence confirmed by a pregnancy test on every study visit.
Exclusion Criteria
- •1\. Known allergy to aliskiren or enalapril or substances contained in these preparations.
- •2\. Angioedema caused by aliskiren or enalapril
- •3\. Weight \< 25 kg.
- •4\. Glomerular filtration rate \= 50 ml/min/1\.73 m2 (measured by iohexol clearance) in children and \= 30 ml/min/1\.73 m2 in adults.
- •5\. Rapid deterioration of kidney function during the latest year of the disease
- •5\. Patients with a renal transplant.
- •6\. Immune complex\-mediated membranoproliferative glomerulonephritis (such as in HIV infection, hepatitis, SLE).
- •7\. Females who breastfeed, are pregnant or planning to become pregnant during the study.
- •8\. Co\-morbidity such as malignancy, congestive heart failure, recent myocardial infarction.
- •9\. Mental incapacity or language barriers to understand the contents of the study design.
Outcomes
Primary Outcomes
Not specified
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