Study Description
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.
This is an open-label, non-randomized, multicenter roll-over extension program (REP) to:
CLNP023X2203, a Phase II trial investigating the dose ranging effects of LNP023 on efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability in primary IgAN patients, and
CLNP023A2301, a Phase III trial, investigating the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of LNP023 in patients with primary IgAN.
Subjects completing the CLNP023X2203 and CLNP023A2301 trials on study drug, who want to continue treatment and who meet the inclusion/exclusion requirements of the roll over extension program, will have the opportunity to receive iptacopan until:
3 years from LPFV of this study CLNP023A2002B, or
the participant no longer derives benefit from iptacopan according to the Investigator, or
the benefit-risk profile of the product in IgAN is no longer positive, or
initiation of maintenance hemodialysis, kidney transplantation or eGFR < 15 mL/min/1.73m2 , or
the product becomes commercially available in a specific country following product launch and subsequent reimbursement for IgAN, where applicable, or
if a marketing application or reimbursement of an investigational product is rejected/not pursued in a region/country for the indication under study or which ever is sooner
Interventions
LNP023
Eligibility Criteria
Inclusion Criteria:
For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period.
eGFR* ≥ 20 ml/min/1.73m2
*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)
Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.
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.
All participants must be on supportive care regimen of ACEi or ARB* as per KDIGO guidelines.
participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study
Exclusion Criteria:
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.
Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023.
Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI)
Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
Participants treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus 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. Rituximab requires 180 days wash out.
Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer.
History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.
Study Location
Novartis Investigative Site
Recruiting
Santa Fe,S3000EPV,Argentina
Novartis Investigative Site
Recruiting
Cordoba,X5016KET,Argentina
Novartis Investigative Site
Recruiting
Adelaide,South Australia,5000,Australia
Novartis Investigative Site
Recruiting
Parkville,Victoria,3065,Australia
Novartis Investigative Site
Recruiting
Edegem,Antwerpen,2650,Belgium
Novartis Investigative Site
Recruiting
Leuven,3000,Belgium
Novartis Investigative Site
Recruiting
Roeselare,8800,Belgium
Novartis Investigative Site
Recruiting
Curitiba,PR,80440-020,Brazil
Novartis Investigative Site
Recruiting
São Paulo,SP,04038-002,Brazil
Novartis Investigative Site
Recruiting
Porto Alegre,RS,90020-090,Brazil
Novartis Investigative Site
Recruiting
Sao Paulo,SP,05403 000,Brazil
Novartis Investigative Site
Recruiting
Oshawa,Ontario,L1G 2B9,Canada
Novartis Investigative Site
Recruiting
Shanghai,200040,China
Novartis Investigative Site
Recruiting
Beijing,100034,China
Novartis Investigative Site
Recruiting
Shanxi,710063,China
Novartis Investigative Site
Recruiting
Qingdao,266000,China
Novartis Investigative Site
Recruiting
Guangzhou,Guangdong,510080,China
Novartis Investigative Site
Recruiting
Yinchuan,Ningxia,100039,China
Novartis Investigative Site
Recruiting
Praha,12808,Czech Republic
Novartis Investigative Site
Recruiting
Aalborg,9000,Denmark
Novartis Investigative Site
Recruiting
Arhus N,DK-8200,Denmark
Novartis Investigative Site
Recruiting
Copenhagen,DK-2100,Denmark
Novartis Investigative Site
Recruiting
Paris,75015,France
Novartis Investigative Site
Recruiting
Freiburg,79106,Germany
Novartis Investigative Site
Recruiting
Berlin,13353,Germany
Novartis Investigative Site
Recruiting
Magdeburg,39120,Germany
Novartis Investigative Site
Recruiting
Heidelberg,69120,Germany
Novartis Investigative Site
Recruiting
Mainz,55131,Germany
Novartis Investigative Site
Recruiting
Hong Kong SAR,Hong Kong
Novartis Investigative Site
Recruiting
New Delhi,110029,India
Novartis Investigative Site
Recruiting
Bangalore,Karnataka,560004,India
Novartis Investigative Site
Recruiting
Petach Tikva,4941492,Israel
Novartis Investigative Site
Recruiting
Jerusalem,9112001,Israel
Novartis Investigative Site
Recruiting
Ashkelon,78278,Israel
Novartis Investigative Site
Recruiting
Napoli,80100,Italy
Novartis Investigative Site
Recruiting
Matsumoto,Nagano,390-8621,Japan
Novartis Investigative Site
Recruiting
Kyoto,605-0981,Japan
Novartis Investigative Site
Recruiting
Osaka-city,Osaka,530-0012,Japan
Novartis Investigative Site
Recruiting
Osaka-city,Osaka,530-8480,Japan
Novartis Investigative Site
Recruiting
Osaka,534-0021,Japan
Novartis Investigative Site
Recruiting
Toyoake city,Aichi,470 1192,Japan
Novartis Investigative Site
Recruiting
Toyota,Aichi,471-8513,Japan
Novartis Investigative Site
Recruiting
Sapporo-city,Hokkaido,006-8555,Japan
Novartis Investigative Site
Recruiting
Sapporo,Hokkaido,060-8604,Japan
Novartis Investigative Site
Recruiting
Okayama-city,Okayama,700-8558,Japan
Novartis Investigative Site
Recruiting
Yokohama-city,Kanagawa,236-0004,Japan
Novartis Investigative Site
Recruiting
Omihachiman,Shiga,523-0082,Japan
Novartis Investigative Site
Recruiting
Seoul,03080,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,03722,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,06973,Korea, Republic of
Novartis Investigative Site
Recruiting
Taegu,41944,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,134 727,Korea, Republic of
Novartis Investigative Site
Recruiting
Cheongju si,Chungcheongbuk Do,28644,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,Korea,03312,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,Seocho Gu,06591,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,02841,Korea, Republic of
Novartis Investigative Site
Recruiting
Kuala Lumpur,50589,Malaysia
Novartis Investigative Site
Recruiting
Kuala Lumpur,59100,Malaysia
Novartis Investigative Site
Recruiting
Groningen,9713 GZ,Netherlands
Novartis Investigative Site
Recruiting
Bergen,5021,Norway
Novartis Investigative Site
Recruiting
Nordbyhagen,Oslo,1478,Norway
Novartis Investigative Site
Recruiting
Singapore,169608,Singapore
Novartis Investigative Site
Recruiting
Taoyuan,33305,Taiwan
Novartis Investigative Site
Recruiting
Kaohsiung,83301,Taiwan
Novartis Investigative Site
Recruiting
Taichung,40447,Taiwan
Novartis Investigative Site
Recruiting
Taichung,40705,Taiwan
Novartis Investigative Site
Recruiting
Taipei,10048,Taiwan
Novartis Investigative Site
Recruiting
Bangkok,10330,Thailand
Novartis Investigative Site
Recruiting
Bangkok,10400,Thailand
Novartis Investigative Site
Recruiting
Talas / Kayseri,38039,Turkey
Novartis Investigative Site
Recruiting
Istanbul,TUR,34098,Turkey
Novartis Investigative Site
Recruiting
Kocaeli,41380,Turkey
Novartis Investigative Site
Recruiting
Leicester,LE5 4PW,United Kingdom
Novartis Investigative Site
Recruiting
Newcastle Upon Tyne,NE7 7DN,United Kingdom
Novartis Investigative Site
Recruiting
London,SE5 9RS,United Kingdom
Novartis Investigative Site
Recruiting
Salford,Manchester,M6 8HD,United Kingdom
Prolato Clinical Research Center
Recruiting
Houston,Saira Rodriguez (832-338-9118) email: [email protected] -- Sreedhar Mandayam,77054 - Texas,United States
AZ Kidney Dise and Hypertension Ctr
Recruiting
Glendale,Claudia Medoza email: [email protected] -- Peter Santos,85308 - Arizona,United States
DaVita Clinical Research
Recruiting
Las Vegas,Tiffannie Shaw (877-896-3844) email: [email protected] -- Mark Vishnepolsky,89146 - Nevada,United States
Nephrology Associates PA
Recruiting
Newark,Joanne Stevens email: [email protected] -- Theodore Saad,19713 - Delaware,United States
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.