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Tests treatment safety and results for C3G
Official title Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
ClinicalTrials.gov ID: NCT04817618
What this study is testing
What is iptacopan?
iptacopan is an investigational medicine, being studied as a potential treatment for c3g.
Also referred to as LNP023.
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 Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol. The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 60
You may be able to join if
- Male and female participants age ≥ 12 and ≤ 60 years at screening.
- Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents.
- Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor...
- Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.
- UPCR ≥ 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15.
You likely can't join if
- Participants who have received any cell or organ transplantation, including a kidney transplantation.
- Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular...
- Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%
- Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local...
- Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration
- The presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
See the full eligibility criteria
- Male and female participants age ≥ 12 and ≤ 60 years at screening.
- Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents.
- Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The...
- Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening.
- UPCR ≥ 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15.
- Estimated GFR (using the CKD-EPI formula for ages ≥ 18 years and modified Schwartz formula for ages 12 to 17 years) or measured GFR ≥ 30 ml/min/1.73m2 at screening and Day -15.
- Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae prior to the start of study treatment.
- If not previously vaccinated or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study...
- Participants who have received any cell or organ transplantation, including a kidney transplantation.
- Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli.
- Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%
- Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.
- Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration
- The presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
- A history of recurrent invasive infections caused by encapsulated organisms, e.g., N. meningitidis and S. pneumoniae.
- The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti C5 antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit.
- The use of immunosuppressants (except mycophenolic acids), cyclophosphamide or systemic corticosteroids at a dose \>7.5 mg/day (or equivalent for a similar medication) within 90 days of study drug administration.
- Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Miami, Florida, United States
- Lawrenceville, Georgia, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Hackensack, New Jersey, United States
- Albany, New York, United States
- New York, New York, United States
- Temple, Texas, United States
- Madison, Wisconsin, United States
- Córdoba, Córdoba Province, Argentina
- Buenos Aires, Argentina
- CABA, Argentina
- Edegem, Belgium
- Leuven, Belgium
- Belo Horizonte, Minas Gerais, Brazil
- Recife, Pernambuco, Brazil
- Passo Fundo, Rio Grande do Sul, Brazil
+ 57 more site(s).
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, 12 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Miami, Florida, United States; Lawrenceville, Georgia, United States; Indianapolis, Indiana, United States; Iowa City, Iowa, United States; Baltimore, Maryland, United States and 71 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.