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Tests treatment safety and results for C3 Glomerulopathy
Official title Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
ClinicalTrials.gov ID: NCT03955445
What this study is testing
What is LNP023?
LNP023 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for c3 glomerulopathy.
Also referred to as iptacopan.
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
- This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis
- Phase 3: a large, late-stage study
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 100
You may be able to join if
- \- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug
You likely can't join if
- Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any...
- Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or the presence of fever ≥ 38oC...
- History or current diagnosis of ECG abnormalities indicating significant risk of safety for people
- History of HIV or any other immunodeficiency disease Other protocol-defined inclusion/exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Lawrenceville, Georgia, United States
- Iowa City, Iowa, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- CABA, Buenos Aires, Argentina
- Buenos Aires, Argentina
- Belo Horizonte, Minas Gerais, Brazil
- Recife, Pernambuco, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Botucatu, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Salvador, Brazil
- Toronto, Ontario, Canada
- Beijing, China
- Shanghai, China
- Prague, Czechia
- Montpellier, France
- Paris, France
- Toulouse, France
+ 30 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 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Lawrenceville, Georgia, United States; Iowa City, Iowa, United States; Minneapolis, Minnesota, United States; New York, New York, United States; CABA, Buenos Aires, Argentina and 44 more location(s). 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.