JRCT ID: jRCT2021210041
Registered date:12/10/2021
A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | IgA Nephropathy |
Date of first enrollment | 26/10/2021 |
Target sample size | 28 |
Countries of recruitment | Australia,Japan,Belgium,Japan,Czech Republic,Japan,Denmark,Japan,Germany,Japan,Netherlands,Japan,Singapore,Japan |
Study type | Interventional |
Intervention(s) | LNP023 monotherapy |
Outcome(s)
Primary Outcome | Safety and tolerability endpoints (including but not limited to adverse events/serious adverse events, safety laboratory parameters, vital signs). |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Signed informed consent must be obtained prior to participation. Participants should be able to communicate well with the Investigator, understand and comply with the requirements of the study. 2. For CLNP023X2203, participants must have completed Part 1 or Part 2 of the trial. For CLNP023A2301, participants must have completed the entire parent trial defined as the full 24 month double-blind period. 3. eGFR >= 20 mL/min/1.73m2 4. Per Investigator clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d. 5. Prior vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations). 6. All participants must be on supportive care regimen of stable dose of ACEi or ARB as per KDIGO guidelines. |
Exclude criteria | 1. Participants who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason. 2. Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with iptacopan. 3. Current (within 4 weeks prior to study treatment administration in the REP) acute kidney injury (AKI) defined by AKIN criteria. 4. Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months. 5. Participants treated with immunosuppressive or other immunmodulatory agents and/or systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter. 6. Use of other investigational drugs at the time of enrollment, or within 5 halflives of enrollment or within 30 days whichever is longer. 7. All transplanted participants (any solid organ, or bone marrow transplantation). 8. History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus, pneumococcus, and H. influenzae. 9. Major concurrent comorbidities including but not limited to severe uncontrolled hypertension, other chronic kidney disease (with or without kidney failure), advanced cardiac disease (e.g., NYHA class IV), severe pulmonary disease (e.g., severe pulmonary hypertension (WHO class IV), or hepatic disease (e.g. active hepatitis) that in the opinion of the Investigator precludes participant's participation in the study. |
Related Information
Primary Sponsor | Yamada Hiroyuki |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04557462 |
Contact
Public contact | |
Name | Hiroyuki Yamada |
Address | Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan Tokyo Japan 105-6333 |
Telephone | +81-120-003-293 |
rinshoshiken.toroku@novartis.com | |
Affiliation | Novartis Pharma. K.K. |
Scientific contact | |
Name | Hiroyuki Yamada |
Address | Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan Tokyo Japan 105-6333 |
Telephone | +81-120-003-293 |
rinshoshiken.toroku@novartis.com | |
Affiliation | Novartis Pharma. K.K. |