Glomerulonephritis, IGAPhase 2NCT06797518
Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN
A Phase 2 study testing Iptacopan in people with Glomerulonephritis, IGA and Immunoglobulin A Nephropathy, run by Novartis Pharmaceuticals at 19 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Glomerulonephritis, IGA, Immunoglobulin A Nephropathy
- What is being tested?
- Iptacopan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 19 sitesin 5 countries
- Study dates
- 21 Feb 2025to 27 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 continue on a stable dose throughout the study. 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. In addition, if participants are taking diuretics, other antihypertensive medication or Sodium-Glucose Co-Transporter 2 inhibitors (SGLT2i), the doses should be stabilized for at least 90 days prior to baseline.
- 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 vaccinated, or if a booster is required, vaccine should be given according to local regulations at least 2 weeks prior to first study drug administration. If study treatment must start earlier than 2 weeks post-vaccination, prophylactic antibiotic treatment should be initiated.
- 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.
Who cannot join
- 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 Immunodeficiency Virus (HIV) infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease, familial Mediterranean fever, etc.
- 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.
Show all 34Show fewer
- 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 sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, systemic corticosteroids exposure (>7.5 mg/d prednisone/prednisolone equivalent) or targeted release formulation (TRF) of budesonide within 90 days (or 180 days for rituximab) prior to first study drug administration. Participants using other medication such us hydroxychloroquine or Endothelin receptor antagonists (ERAs).
- 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 Organization (WHO) class IV)), or hepatic disease (e.g., active hepatitis) that in the opinion of the investigator precludes participant's participation in the study.
- 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 indicated by abnormal liver function tests at screening as defined below:
- 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 whether there is evidence of local recurrence or metastases.
- 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 test.
- 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 stopping of investigational drug.
- 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.
- 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 alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- 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 efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS).
- 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 of childbearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential.
- If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the ICF.
Trial locations and contacts
19 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
19 sites in 5 countries
United States9 sites, 9 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Ashlee Chatham, +1 205 934 3734, ashleechatham@uabmc.edu
Dana Rizk
- Recruiting
CaRe Research
Chubbuck, Idaho, 83202
Carolina Saldana, +1 208 904 4780, carolina@cardiorenalinstitute.com
Hira Siktel
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Tricia Young, +1 216 844 5396, tricia.young@uhhospitals.org
Andrew Lazar
- Recruiting
OSU Wexner Medical Center
Columbus, Ohio, 43210
Alexander Mc Daniels, +1 614 293 4098, Alexander.McDaniels@osumc.edu
Isabelle Ayoub
- Recruiting
Prolato Clinical Research Center
Houston, Texas, 77054
Meadia Arabzada, +1 832 338 9118, marabzada@prolato.org
Sreedhar Mandayam
- Recruiting
DaVita Clinical Research
Las Vegas, Nevada, 89146
Farzana Siddiqui, farzana.siddiqui@davita.com
Mark Vishnepolsky
- Recruiting
Georgia Nephrology Research Inst
Lawrenceville, Georgia, 30046
Vivian Luu, +1 404 645 7850#3024, vluu@nephronet.com
James A Tumlin
- Recruiting
UCLA Medical Center
Los Angeles, California, 90095
Jessica Gomez, jesgomez@mednet.ucla.edu
Mrinalini Sarkar
- Recruiting
Central Florida Kidney Specialists
Orlando, Florida, 32806
Felipe Gomez, +1 407 816 5700, felipe.gomez@clintrialresearch.com
Arvind Madan
Israel4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Ashdod, 7747629
- Recruiting
Novartis Investigative Site
Hadera, 3820302
- Recruiting
Novartis Investigative Site
Haifa, 3109601
- Recruiting
Novartis Investigative Site
Nahariya, 2210001
Argentina3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
CABA, Buenos Aires, 1425
- Recruiting
Novartis Investigative Site
CABA, Buenos Aires, C1280AEB
- Recruiting
Novartis Investigative Site
Córdoba, Córdoba Province, X5016KET
Malaysia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, 50586
- Recruiting
Novartis Investigative Site
Kuala Lumpur, Selangor, 43000
Saudi Arabia1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Riyadh, 11211
About this study
Official title: A Multicenter, Single Arm, Open Label Biopsy Study to Evaluate Structural and Functional Changes in Kidneys of Adult Patients With IgA Nephropathy Receiving Iptacopan on Top of Supportive Care
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.
Read the detailed description
The study comprises of a screening period followed by a baseline visit, at which a baseline kidney biopsy will be performed. Eligible participants included in the study will receive iptacopan 200 mg b.i.d for a 9-month treatment period. Dose adjustment of iptacopan is not allowed during the treatment period. At Month 9, upon completion of the treatment period, a follow up biopsy is performed for all participants at the time of end of study (EOS).
- Being tested
- Iptacopan
- Keywords
- IgAN, Renal Biopsy, Iptacopan
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IptacopanDrug
Also called LNP023
LNP023 oral capsule 200 mg b.i.d
| Study group | Role | What they receive |
|---|---|---|
| Iptacopan | Experimental | All the study participants will receive iptacopan 200 mg oral capsule b.i.d, while remaining on the maximally tolerated or locally approved maximal daily doses of ACEi/ARB throughout the treatment period. Receives: Drug: Iptacopan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving a reduction of minimum one order of magnitude in complement C3c mesangial deposition.
Mesangial C3c deposition is assessed by intensity of immunofluorescence (IF) staining using the following grading system: 0 (absent) 1 (+) 2 (++) 3 (+++)
Measured: BSL, Month 9
Secondary outcomes (2)
Change from baseline at 9 months in CD68 cells
To describe the histopathological changes in additional biomarkers after treatment with iptacopan
Measured: BSL, Month 9
Change from baseline at 9 months in staining of Immunoglobulins (IgA and IgG)
To describe the histopathological changes in additional biomarkers after treatment with iptacopan
Measured: BSL, Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start21 Feb 2025
- Primary completion27 Nov 2027 (estimated)
- Study completion27 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerulonephritis, IGAStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797518
- Sponsor's protocol ID
- CLNP023A2201
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single Arm, Open Label Biopsy Study to Evaluate Structural and Functional Changes in Kidneys of Adult Patients With IgA Nephropathy Receiving Iptacopan on Top of Supportive Care
- ClinicalTrials.gov ID
- NCT06797518
- Acronym / sponsor ID
- CLNP023A2201
- Keywords
- IgAN, Renal Biopsy, Iptacopan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 27 Nov 2027 (estimated)
- Study completion
- 27 Nov 2027 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study comprises of a screening period followed by a baseline visit, at which a baseline kidney biopsy will be performed. Eligible participants included in the study will receive iptacopan 200 mg b.i.d for a 9-month treatment period. Dose adjustment of iptacopan is not allowed during the treatment period. At Month 9, upon completion of the treatment period, a follow up biopsy is performed for all participants at the time of end of study (EOS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iptacopan | Experimental | Drug: IptacopanAll the study participants will receive iptacopan 200 mg oral capsule b.i.d, while remaining on the maximally tolerated or locally approved maximal daily doses of ACEi/ARB throughout the treatment period. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 continue on a stable dose throughout the study. 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. In addition, if participants are taking diuretics, other antihypertensive medication or Sodium-Glucose Co-Transporter 2 inhibitors (SGLT2i), the doses should be stabilized for at least 90 days prior to baseline.
Key exclusion criteria (34 listed)
- 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 Immunodeficiency Virus (HIV) infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, and inflammatory bowel disease, familial Mediterranean fever, etc.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IptacopanAlso: LNP023LNP023 oral capsule 200 mg b.i.d | Drug | Iptacopan |
Primary outcome
Proportion of participants achieving a reduction of minimum one order of magnitude in complement C3c mesangial deposition.
Time frame: BSL, Month 9
Mesangial C3c deposition is assessed by intensity of immunofluorescence (IF) staining using the following grading system: 0 (absent) 1 (+) 2 (++) 3 (+++)
2 secondary outcomes
Change from baseline at 9 months in CD68 cells
Time frame: BSL, Month 9
Change from baseline at 9 months in staining of Immunoglobulins (IgA and IgG)
Time frame: BSL, Month 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iptacopan in people with Glomerulonephritis, IGA and Immunoglobulin A Nephropathy, run by Novartis Pharmaceuticals at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Israel, Argentina, Malaysia, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving a reduction of minimum one order of magnitude in complement C3c mesangial deposition. (time frame: BSL, Month 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.