Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy (NCT04183101) | Clinical Trial Compass
RecruitingPhase 2
Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy
Sweden30 participantsStarted 2020-10-01
Plain-language summary
The aim of this cross-over trial is to assess aliskiren, a direct renin inhibitor, as a novel treatment to block complement activation in the kidneys and thereby attenuate renal disease and stabilize or improve kidney function and compare it to the currently used treatment with the angiotensin converting enzyme inhibitor, enalapril, in patients with the complement-mediated renal disease C3 glomerulopathy. Patients will be randomized to one or the other treatment for the first 6 months and then switch to the other treament for the following 2.5 years. Treatment will continue for altogether 3 years for each patient.
Who can participate
Age range6 Years
SexALL
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Inclusion criteria
✓. Children ≥ 6 years and adults.
✓. 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.
✓. Either absence of treatment at the study start or ongoing treatment with aliskiren, angiotensin converting enzyme inhibitors, angiotensin receptor blockers or immune suppressive medications (such as mycophenolate mofetil/MMF or corticosteroids)
✓. Written informed consent has been given by:
✓. the patient's legal guardians if the patient is less than 15 years old
✓. the patient and his/her legal guardians if the patient is ≥ 15 but \< 18 years old
✓. the patient, if the patient is ≥ 18 years old
✓. Female subjects of childbearing potential must:
Exclusion criteria
✕. Known allergy to aliskiren, ACEi or substances contained in these preparations.