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Tests treatment safety and results for Primary Immunoglobulin A Nephropathy (IgAN)
Official title Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN
ClinicalTrials.gov ID: NCT06994845
What this study is testing
What is iptacopan?
iptacopan is an investigational medicine, given as an once-daily, being studied as a potential treatment for primary immunoglobulin a nephropathy (igan).
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 study is an open-label, single arm, multicenter, Phase III study to determine proteinuria reduction, pharmacokinetics (PK), safety and tolerability (including CV surveillance) of iptacopan in primary immunoglobulin A nephropathy (IgAN) pediatric patients aged 2 to \<18 years.
- Phase 3: a large, late-stage study
- Time commitment: about 52 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- Male and female participants 2 to \< 18 years of age as of Day 1.
- eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period.
- Kidney biopsy-proven primary IgAN\ , with biopsy performed within 3 years of Screening with \< 50% tubulointerstitial fibrosis and \< 25% crescents...
- The minimum body weight for participants in Cohort 1 is 35 kg at Screening and confirmed at Baseline (Day 1).
- Proteinuria due to primary diagnosis of IgAN as assessed by UPCR ≥ 1 g/g (113 mg/mmoL) sampled from FMV at Screening on Day -90 and Day -60 as well...
You likely can't join if
- Any secondary IgAN observed at Screening (and confirmed at Baseline/Day 1) as defined by the Investigator; secondary IgAN can be associated with...
- A clinical diagnosis of immunoglobulin A vasculitis (IgAV or Henoch-Schonlein purpura) based on typical palpable purpura with or without arthralgia...
- Evidence of significant urinary obstruction or difficulty in voiding at Screening (and confirmed at Baseline/Day 1); any urinary tract disorder or...
- Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of screening.
- Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to Screening or during the...
- Presence of nephrotic syndrome at Screening based on the investigator's judgment.
See the full eligibility criteria
- Male and female participants 2 to \< 18 years of age as of Day 1.
- eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period.
- Kidney biopsy-proven primary IgAN\ , with biopsy performed within 3 years of Screening with \< 50% tubulointerstitial fibrosis and \< 25% crescents. In case a kidney biopsy within 3 years from Screening is not...
- The minimum body weight for participants in Cohort 1 is 35 kg at Screening and confirmed at Baseline (Day 1).
- Proteinuria due to primary diagnosis of IgAN as assessed by UPCR ≥ 1 g/g (113 mg/mmoL) sampled from FMV at Screening on Day -90 and Day -60 as well as during the Run-in Period despite treatment with maximum tolerated...
- Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection is required prior to the start of study treatment. If the participant has not been previously vaccinated, or if a booster is required...
- Vaccination against Haemophilus influenzae is recommended, according to local guidelines, at least 2 weeks before iptacopan.
- All participants must have been on supportive care including stable dose regimen of ACE inhibitor or ARB at either the locally approved maximal daily dose per body weight, or the maximally tolerated dose (per...
- Any secondary IgAN observed at Screening (and confirmed at Baseline/Day 1) as defined by the Investigator; secondary IgAN can be associated with cirrhosis, celiac disease, human immunodeficiency virus (HIV) infection...
- A clinical diagnosis of immunoglobulin A vasculitis (IgAV or Henoch-Schonlein purpura) based on typical palpable purpura with or without arthralgia and abdominal pain.
- Evidence of significant urinary obstruction or difficulty in voiding at Screening (and confirmed at Baseline/Day 1); any urinary tract disorder or any chronic kidney disease other than IgAN at Screening and before first...
- Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of screening.
- Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to Screening or during the Screening and Run-in periods.
- Presence of nephrotic syndrome at Screening based on the investigator's judgment.
- History or current diagnosis of ECG abnormalities indicating significant risk for study participants such clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, or clinically significant...
- History or current diagnosis of clinically significant echocardiogram abnormalities indicating significant risk for study participants including but not limited to clinically significant functional, morphological and/or...
- Participants of 12 to \ 150 mmHg, or diastolic blood pressure (DBP) \ 95 mmHg, or pulse rate \ 110 bpm; participants of 6 to \ 140 mmHg, or DBP \ 90 mmHg or pulse rate \ 156 bpm; participants of 2 to \ 120 mmHg, or DBP...
- Participants previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate...
- All transplanted participants (any solid organ transplantation, including bone marrow transplantation).
- History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.
- Major concurrent comorbidities at Screening including but not limited to advanced cardiac disease (e.g. New York Heart Association (NYHA) class III (for 6 to \<18 years of age), Ross class III (for 2 to \< 6 years of...
- Current use of any homeopathic and/or herbal medications for IgAN disease progression, such as but not limited to Lei Gong Teng at Screening (and confirmed at Baseline/Day 1). Other protocol-defined inclusion/exclusion...
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Philadelphia, Pennsylvania, United States
- Salt Lake City, Utah, United States
- Brisbane, Queensland, Australia
- Nedlands, Western Australia, Australia
- Hangzhou, Zhejiang, China
- Beijing, China
- Hong Kong, Hong Kong
- Beersheba, Israel
- Haifa, Israel
- Jerusalem, Israel
- Petah Tikva, Israel
- Toyoake, Aichi-ken, Japan
- Kurume, Fukuoka, Japan
- Ohtsu, Shiga, Japan
- Fuchū, Tokyo, Japan
- Riyadh, Saudi Arabia
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 study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Philadelphia, Pennsylvania, United States; Salt Lake City, Utah, United States; Brisbane, Queensland, Australia; Nedlands, Western Australia, Australia; Hangzhou, Zhejiang, China and 11 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.