Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6+
SponsorRegion Skane

About this trial

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.

Eligibility criteria

Qualifiers

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)

the patient's legal guardians if the patient is less than 15 years old

Disqualifiers

Known allergy to aliskiren, ACEi or substances contained in these preparations.

Angioedema caused by aliskiren or enalapril

Weight < 25 kg

Glomerular filtration rate ≤ 50 ml/min/1.73 m2 (measured by iohexol clearance) in children and ≤ 30 ml/min/1.73 m2 in adults.

Trial design

Treatments tested in this trial

  • Aliskiren
  • Enalapril

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators