BridgeMD
A rollover extension program (REP) to evaluate the long-term safety and tolerability of open label iptacopan in adult participants with primary IgA nephropathy
EU CTIS ID: 2023-508690-92-00
What this study is testing
The primary objective is to evaluate the long-term safety and tolerability of iptacopan in eligible participants.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent must be obtained prior to participation in the REP; participants should be able to communicate well with the Investigator, understand and comply with the requirements of the study.
- For CLNP023X2203, participants must have completed Part 1 or Part 2 of the trial. For other parent trials participants must have completed the entire parent trial duration defined by the respective protocol.
- 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 judgment, 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 stable dose of ACEi or ARB* as per KDIGO guidelines (KDIGO 2021). * Participants with allergies or intolerance to ACEi and ARB are eligible for the study but the Investigator should clearly document the reasons for not being on maximal ACEi/ARB dose in the source documents.
You likely can't join if
- Participants who are screen or baseline failed in any of the iptacopan parent studies in IgAN or who prematurely withdrew from iptacopan parent studies in IgAN 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 iptacopan.
- Current (within 4 weeks prior to study treatment administration in the REP) acute kidney injury (AKI) defined by AKIN criteria.
- Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
- Participants treated with immunosuppressive or other immunomodulatory 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 90 days prior to first study drug administration. Rituximab requires 180 days wash out. Participants treated with endothelin (receptor) antagonists within 90 days prior to first study drug administration.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment or within 30 days whichever is longer
See the full eligibility criteria
Who can join
- Signed informed consent must be obtained prior to participation in the REP; participants should be able to communicate well with the Investigator, understand and comply with the requirements of the study.
- For CLNP023X2203, participants must have completed Part 1 or Part 2 of the trial. For other parent trials participants must have completed the entire parent trial duration defined by the respective protocol.
- 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 judgment, 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 stable dose of ACEi or ARB* as per KDIGO guidelines (KDIGO 2021). * Participants with allergies or intolerance to ACEi and ARB are eligible for the study but the Investigator should clearly document the reasons for not being on maximal ACEi/ARB dose in the source documents.
What rules you out
- Participants who are screen or baseline failed in any of the iptacopan parent studies in IgAN or who prematurely withdrew from iptacopan parent studies in IgAN 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 iptacopan.
- Current (within 4 weeks prior to study treatment administration in the REP) acute kidney injury (AKI) defined by AKIN criteria.
- Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
- Participants treated with immunosuppressive or other immunomodulatory 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 90 days prior to first study drug administration. Rituximab requires 180 days wash out. Participants treated with endothelin (receptor) antagonists within 90 days prior to first study drug administration.
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment or within 30 days whichever is longer
- History of recurrent invasive infections caused by encapsulated organisms, such as Neisseria meningitidis, Streptococcus pneumoniae and Hemophilus influenzae.
- All transplanted participants (any solid organ, or bone marrow transplantation).
- 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.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms). Women of child-bearing potential are excluded unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods include: • Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. • Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks before taking study treatment). • Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to screening provided partner(s) has (have) received medical assessment of the surgical success. • Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For UK: with spermicidal foam/gel/film/cream/vaginal suppository. • Use of hormonal contraception methods: • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal. • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable. • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) In case of use of hormonal contraception women participants should have been stable on the same method for a minimum of 3 months before taking study treatment. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.
- Any medical condition deemed likely to interfere with the participant’s participation in the study.
- Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study treatment administration.
- Presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
- History of Human Immunodeficiency Virus (HIV) infection (known history of HIV or test positive for HIV antibody at Screening).
- Liver disease or liver injury as indicated by abnormal liver function tests (LFT) at screening as defined below. ALT (SGPT), AST (SGOT), GGT, alkaline phosphatase and serum bilirubin will be tested. • Any single parameter of ALT, AST, GGT, alkaline phosphatase must not exceed 3 × upper limit of normal (ULN) • Serum bilirubin must not exceed 2 × ULN Participants from CLNP023X2203 study or any other parent study participants if required by local regulations will be additionally tested for HBsAg and HCV-RNA and are not eligible if the results are positive.
- History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes or any participant who discontinued study treatment in the parent study due to a suspected treatment-related AE.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer treated with curative intent), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Pregnant or breastfeeding females, where pregnancy is confirmed by a positive Human Chorionic Gonadotrophin (HCG) test.
The study team makes the final eligibility decision.
Where it's taking place
- China
- Turkey
- Malaysia
- Israel
- Hong Kong
- Australia
- Argentina
- Korea, Republic of
- Brazil
- United Kingdom
- Singapore
- Taiwan
- Russian Federation
- Thailand
- Colombia
- Japan
- Mexico
- India
- Canada
- United States
+ 1 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Turkey; Malaysia; Israel; Hong Kong; Australia and 15 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 EU CTIS; the study team decides eligibility.