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

StatusRecruiting
PhasePhase 2
Started2020-10-01
View on ClinicalTrials.gov ↗

Amendment history

2025-06-19
Study Status v6
Re-verified, no change to tracked fields
2024-06-17
Study Status v5
Primary completion date2024-12→2029-12
Completion date2024-12→2029-12
2023-03-28
2 amendments v3-v4
2 re-verifications since 2022-01-04, no change to tracked fields
2020-10-06
Not Yet Recruiting→Recruiting Study Status, Study Description, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-06→confirmed 2020-10-01
Eligibility criteria+61 characters
[...] ent at the study start or ongoing treatment with aliskiren, ACEiangiotensin converting enzyme inhibitors, ARBsangiotensin receptor blockers or immune suppressive medications (such as mycophenolate mo [...]
Study description+42 characters
[...] opathy as compared to the currently used treatment with the angiotensin converting enzyme inhibitor (ACEi) enalapril. Secondary objectives are to assess the effect of [...]
Study sitesdetails revised at 4 of 4 sites
2020-03-10
Study Status v1
Start date2020-01→2020-06
2019-11-27
Original filing
Region Skane
146 trials monitored
See 5 trials at risk
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.
Trial Details
NCT Number NCT04183101
Lead Sponsor Region Skane
Conditions C3 Glomerulopathy, Membranoproliferative Glomerulonephritis, Complement Abnormality, Dense Deposit Disease, C3 Glomerulonephritis
Enrollment 30 participants
Start Date 2020-10-01
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2025-06-22