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Compares treatment options for C3 Glomerulopathy
Official title Evaluation of a Renin Inhibitor, Aliskiren, Compared to Enalapril, in C3 Glomerulopathy
ClinicalTrials.gov ID: NCT04183101
What this study is testing
What is Aliskiren?
Aliskiren is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for c3 glomerulopathy.
Also referred to as Enalapril.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older
You may be able to join if
- 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...
- Either absence of treatment at the study start or ongoing treatment with aliskiren, angiotensin converting enzyme inhibitors, angiotensin receptor...
- Written informed consent has been given by:
- the patient's legal guardians if the patient is less than 15 years old
You likely can't join if
- 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.
- Rapid deterioration of kidney function during the latest year of the disease
- Patients with a renal transplant
See the full eligibility 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...
- 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 people of childbearing potential must:
- Understand that the study medication is expected to have a teratogenic risk
- Agree to use a highly effective contraceptive during study drug therapy. This applies unless the subject is less than 18 years of age, has not had sexual debut and commits to sexual abstinence confirmed by a pregnancy...
- Combined (estrogen and progesterone) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable
- Intrauterine device
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence
- Male or female condom with or without spermicide
- Cap, diaphragm or sponge with spermicide
- Agree to have a pregnancy test before the start of study medication. This requirement also applies to women of childbearing age who practice complete and continued abstinence and adolescent girls after menarche.
- Agree to have a pregnancy test every 3rd month including at the end of study treatment, except in the case of confirmed tubal sterilization. This requirement also applies to women of childbearing age who practice...
- 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.
- Rapid deterioration of kidney function during the latest year of the disease
- Patients with a renal transplant
- Immune complex-mediated membranoproliferative glomerulonephritis (such as in HIV infection, hepatitis, SLE)
- Females who breastfeed, are pregnant or planning to become pregnant during the study.
- Co-morbidity such as malignancy, congestive heart failure, recent myocardial infarction.
- Mental incapacity or language barriers to understand the contents of the study design.
- Simultaneous use of another complement-antagonist (such as eculizumab). Eculizumab must be discontinued and complement activity normalized before the start of study drug.
- Simultaneous use of aliskiren or enalapril with cyclosporine or nonsteroidal anti-inflammatory drugs (NSAID).
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
- Lund, Sweden
- Stockholm, Sweden
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden; Lund, Sweden; Stockholm, Sweden; Uppsala, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.