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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515892-36-00
Enrollment
30
Registered
2024-07-10
Start date
2020-01-01
Completion date
Unknown
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C3 glomerulopathy

Brief summary

Serum C3 during the cross-over study., Serum C3 and complement deposition in renal biopsies during the extension study.

Detailed description

Complement activation (such as serum C3a, C3d, C5a and other complement assays), Proteinuria, Kidney function, Kidney biopsy findings, Blood pressure, Activation of the renin-angiotensin system

Interventions

DRUGRasilez 300 mg film-coated tablets

Sponsors

Region Skane
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Serum C3 during the cross-over study., Serum C3 and complement deposition in renal biopsies during the extension study.

Secondary

MeasureTime frame
Complement activation (such as serum C3a, C3d, C5a and other complement assays), Proteinuria, Kidney function, Kidney biopsy findings, Blood pressure, Activation of the renin-angiotensin system

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026