Complement component 3 glomerulopathy, Immune-complex-membranoproliferative glomerulonephritis
Conditions
Interventions
Iptacopan(LNP023) 200 mg b.i.d.
Sponsors
Maruyama Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed. 2. Male and female participants 12 years of age or greater at screening. 3. Participants must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug. 4. Adult participants must be able to communicate well with the investigator, understand and comply with the requirements of the study [applicable in Germany only] 4a. Participants or their legal representatives must be able to communicate well with the investigator, understand and comply with the requirements of the study [applicable in all countries except in Germany for adult participants].
Exclusion criteria
Exclusion criteria: 1. Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating iptacopan or complying with the requirements of the study. 2. Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or The presence of fever >= 38 degree Celsius (100.4 degree Fahrenheit) within 7 days prior to screening. 3. History or current diagnosis of ECG abnormalities indicating significant risk of safety for participants participating in the study such as: -Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker -History of familial long QT syndrome or known family history of Torsades de Pointe. 4. Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of the study. 5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of clinically significant vital signs (msDBP, msSBP, heart rate), ECGs, and safety laboratory measurements, as well as adverse events (AEs), AEs of special interest, and study drug discontinuation due to an AE (or any safety issue). | — |
Countries
Argentina, Belgium, Brazil, Canada, China, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Spain, Switzerland, Turkey, UK, US
Contacts
Public ContactHideki Maruyama
Novartis Pharma. K.K.
Outcome results
None listed