Actively Recruiting
Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy
Led by Region Skane · Updated on 2025-06-22
30
Participants Needed
4
Research Sites
478 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 years and older and adults
- Diagnosis of Dense Deposit Disease or C3 glomerulonephritis confirmed by kidney biopsy within 2 years before first study drug dose
- Either no treatment at study start or ongoing treatment with aliskiren, ACE inhibitors, angiotensin receptor blockers, or immune suppressive medications such as mycophenolate mofetil or corticosteroids
- Written informed consent obtained from patient or legal guardians as appropriate by age
- Female participants of childbearing potential must understand teratogenic risks, agree to use effective contraception during treatment, and undergo pregnancy testing as required
You will not qualify if you...
- Known allergy to aliskiren, enalapril, or ingredients in these drugs
- History of angioedema caused by aliskiren or enalapril
- Weight less than 25 kilograms
- Glomerular filtration rate 50 ml/min/1.73 m2 or lower in children, or 30 ml/min/1.73 m2 or lower in adults
- Rapid worsening of kidney function within the last year
- Patients with kidney transplants
- Immune complex-mediated membranoproliferative glomerulonephritis (e.g., due to HIV, hepatitis, SLE)
- Females who are pregnant, breastfeeding, or planning pregnancy during the study
- Co-existing serious illnesses such as cancer, heart failure, or recent heart attack
- Mental incapacity or language barriers preventing understanding of the study
- Use of other complement-antagonist drugs like eculizumab without discontinuation and normalization of complement activity
- Concurrent use of aliskiren or enalapril with cyclosporine or NSAIDs
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Sahlgrenska Hospital
Gothenburg, Sweden
Not Yet Recruiting
2
Region Skåne Skåne Universitetssjukhus
Lund, Sweden, 22184
Actively Recruiting
3
Karolinska Hospital
Stockholm, Sweden
Not Yet Recruiting
4
Akademiska sjukhuset
Uppsala, Sweden
Not Yet Recruiting
Research Team
D
Diana Karpman, MD PhD
CONTACT
Z
Zivile Bekassy, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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