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New treatment option for Glomerulonephritis, IGA
Official title Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN
ClinicalTrials.gov ID: NCT06797518
What this study is testing
What is Iptacopan?
Iptacopan is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for glomerulonephritis, iga.
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
- A study to investigate the impact of iptacopan treatment on the underlying immunopathology in patients with IgAN by assessing changes in key clinical and molecular markers from baseline to 9 months. The study aims to provide insights into the treatment's systemic and kidney-specific aspects by quantifying the change in mesangial C3c containing fragments deposition, as an indicator of complement activation, and evaluating a variety of biomarkers related to kidney function, damage, and disease progression, including but not limited to Oxford MEST-C score.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Signed informed consent must be obtained prior to participation in the study; participants should be able to communicate well with the investigator...
- Male and female participants ≥18 years of age with biopsy-confirmed IgA nephropathy and an eGFR ≥ 30 mL/min/1.73m2. eGFR will be calculated using the...
- Proteinuria as assessed at screening by UPCR ≥ 0.8g/g or 1g/d sampled from FMV.
- Biopsy at baseline should confirm IgAN with \< 50% tubulointerstitial fibrosis.
- Participants must be on ACEi or ARB treatment at either the locally approved maximal daily dose or the maximally tolerated dose (per investigators'...
You likely can't join if
- Any secondary IgAN (at historic or baseline biopsies) as defined by the investigator and IgA vasculitis Henoch-Scholein Purpura (HSP). Secondary IgAN...
- Any secondary diagnosis at baseline biopsy (other than IgA nephropathy).
- Evidence of significant urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before first study...
- Current or planned usage of any homeopathic and/or herbal medications for IgAN disease progression, such as but not limited to Lei Gong Teng.
- 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 presence of...
See the full eligibility criteria
Who can join
- Signed informed consent must be obtained prior to participation in the study; participants should be able to communicate well with the investigator, understand and comply with the requirements of the study.
- Male and female participants ≥18 years of age with biopsy-confirmed IgA nephropathy and an eGFR ≥ 30 mL/min/1.73m2. eGFR will be calculated using the CKD-EPI 2009 formula.
- Proteinuria as assessed at screening by UPCR ≥ 0.8g/g or 1g/d sampled from FMV.
- Biopsy at baseline should confirm IgAN with \< 50% tubulointerstitial fibrosis.
- Participants must be on ACEi or ARB treatment at either the locally approved maximal daily dose or the maximally tolerated dose (per investigators' judgment) for approximately 90 days prior to baseline visit and...
- Vaccination against Neisseria meningitidis and Streptococcus pneumoniae infections required to be completed at least 2 weeks prior to the start of study treatment. If the participants have not been previously...
- Vaccination against Haemophilus influenzae infection should be given, if available and according to local regulations, at least 2 weeks prior to first study drug administration.
What rules you out
- Any secondary IgAN (at historic or baseline biopsies) as defined by the investigator and IgA vasculitis Henoch-Scholein Purpura (HSP). Secondary IgAN can be associated with cirrhosis, celiac disease, Human...
- Any secondary diagnosis at baseline biopsy (other than IgA nephropathy).
- Evidence of significant urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before first study drug administration.
- Current or planned usage of any homeopathic and/or herbal medications for IgAN disease progression, such as but not limited to Lei Gong Teng.
- 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 presence of nephrotic syndrome.
- Sitting office SBP \>140 mmHg or DBP \>90 mmHg at the screening visit.
- Participants treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate...
- Use of other investigational drugs within 5 half-lives or within 30 days of enrollment, whichever is longer.
- Prior use of iptacopan or prior enrollment in any other iptacopan clinical trial where study drug was taken, including matching placebo.
- 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 including but not limited to advanced cardiac disease (e.g., New York Heart Association (NYHA) class IV), severe pulmonary disease (e.g., severe pulmonary hypertension (World Health...
- Any medical condition deemed likely to interfere with the participant's participation in the study or that will require the use of prohibited medications.
- Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration.
- Presence of fever ≥ 38°C (100.4°F) within 7 days prior to study drug administration.
- Human immunodeficiency virus (HIV) infection (known history of HIV or test positive for HIV antibody at Screening).
- History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
- Liver disease, such as active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as positive HBsAg in conjunction with core antibody (anti-HBc), or HCV-RNA positive at screening, or liver injury as...
- 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
- 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...
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (HCG) laboratory...
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they agree to use effective methods of contraception during dosing of investigational drug and for 1 week after...
- 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...
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy...
- Male sterilization (at least 6 months prior to screening) of male partner of the female participant.
- 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 oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable how well it works (failure rate \<1%), for example hormone...
- In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking investigational drug.
- If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the ICF.
- Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms). Women are considered not...
- If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Orlando, Florida, United States
- Lawrenceville, Georgia, United States
- Chubbuck, Idaho, United States
- Las Vegas, Nevada, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Houston, Texas, United States
- CABA, Buenos Aires, Argentina
- Córdoba, Córdoba Province, Argentina
- Ashdod, Israel
- Hadera, Israel
- Haifa, Israel
- Nahariya, Israel
- Kuala Lumpur, Selangor, Malaysia
- 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 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 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Los Angeles, California, United States; Orlando, Florida, United States; Lawrenceville, Georgia, United States; Chubbuck, Idaho, United States; Las Vegas, Nevada, United States 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.