Takayasu ArteritisPhase 4NCT07325357
Effect of Pirfenidone on TA Fibrosis
A Phase 4 study testing Pirfenidone Capsules in people with Takayasu Arteritis, run by Shanghai Zhongshan Hospital.
Trial summary
Takayasu arteritis is a severe vasculitis which could lead to significant disability and even death. While standard anti-inflammatory treatments can manage the systemic inflammation, they failed to stop a key driver of the disease: vascular fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Takayasu Arteritis
- What is being tested?
- Pirfenidone Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 31 Dec 2030
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who have signed the informed consents and meet the ACR 2022 classification criteria for Takayasu arteritis.
- Male or female, age between 18 and 60 years.
- Female patients must have a negative serum or urine pregnancy test and do not have pregnancy plans during the study period.
- Within the 3 months prior to enrollment, the patient's treatment regimen must consist of glucocorticoids and immunosuppressants (methotrexate). Biological agents (IL-6R, TNF, or monoclonal antibody) might be used based on clinical need. Other targeted therapies (such as CD20 monoclonal antibodies, JAK inhibitors, etc.) or cell-based therapies (such as CAR-T or stem cell therapy) are not permitted.
- During the 6-month follow-up period, the dosage and frequency of existing methotrexate and biologics (IL-6R monoclonal antibody, TNF monoclonal antibody, IL17 monoclonal antibody) must remain unchanged, except for adjustments of glucocorticoid doses based on clinical condition.
- After 3 months of the above combination glucocorticoid and immunosuppressants, patients must achieve remission of disease activity (NIH score <2) and meet at least 3 of the following 5 criteria:
Show all 27Show fewer
- Thickening of the affected vessel wall accompanied by luminal stenosis validated by angiographic examination.
- Carotid ultrasound showing medium-to-high echogenicity of the carotid artery wall.
- Progression in the thickness of the affected arterial wall compared to previous 3 months, with or without progression of luminal stenosis.
- Improvement in the thickness of the affected arterial wall of <10% compared to previous 3 months.
- Within the 3 months prior to enrollment, the occurrence of new vascular ischemic symptoms or ischemic events, or worsening of pre-existing vascular ischemic symptoms. The ischemic symptoms or events must meet at least one of the criteria listed in the table below: Category (Criterion) Vascular Ischemic Signs
- New emerged vascular bruits (carotid, subclavian, or renal arteries).
- Newly emerged absent pulses (carotid, subclavian, brachial, radial, femoral, or dorsalis pedis arteries).
- New emerged systolic blood pressure difference ≥10 mmHg between left and right arms.
- New emerged systolic blood pressure difference ≥30 mmHg between ipsilateral upper and lower limbs.
- Intermittent claudication in upper or lower limbs.
- Cardiac
- For non-hypertensive patients, blood pressure elevation to >140/90 mmHg.
- For hypertensive patients, an increase in diastolic blood pressure ≥20 mmHg from baseline.
- Ischemic angina.
- Myocardial infarction.
- Aortic valve insufficiency (moderate or severe).
- Cerebral
- Ischemic stroke.
- New emerged ischemic symptoms: syncope, visual or auditory abnormalities such as decreased vision, visual field defects, etc.
- CT cerebral perfusion imaging indicating ischemic or infarcted areas (with a corresponding volume >10 ml detected by CTP software).
- Renal Radionuclide renogram showing a decrease in glomerular filtration rate over 10%; or an increase in serum creatinine exceeding 50% compared with the baseline.
Who cannot join
- Presence of autoimmune diseases or autoinflammatory diseases other than Takayasu arteritis (e.g., systemic lupus erythematosus, ankylosing spondylitis, rheumatoid arthritis, etc.);
- Use of antifibrotic drugs or drugs with potential antifibrotic properties (such as acetylcysteine, nintedanib, pirfenidone, etc.) within 6 months prior to enrollment, or participation in other clinical trials involving antifibrotic therapies;
- Impaired liver function (elevated transaminases ALT/AST >2 times the upper limit of normal, or bilirubin exceeding the upper limit of normal), severe renal insufficiency (eGFR <15 mL/min/1.73m²), or requirement for psychotropic medications (excluding sleep medicine for sleep disorders);
- Any severe, progressive, or uncontrolled concurrent hematological, gastrointestinal, pulmonary, cardiac, neurological, or other medical conditions unrelated to Takayasu arteritis which could pose unpredictable risks, in the investigator's judgment;
- Allergy to the investigational drug or previous failure of regular pirfenidone treatment for 3 months;
- Due to pirfenidone's metabolism primarily via cytochrome P450 isoenzymes (particularly CYP1A2), use of CYP1A2 inducers or inhibitors prior to enrollment must be discontinued and avoided throughout the study period; such medications are also prohibited during the study unless deemed medically necessary by the investigator for managing adverse events;
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- History of allergy to MRA contrast agents;
- Planned vascular surgery during the 6-month follow-up period which may interfere with assessment results.
- CYP1A2 Inhibitors:
- Acyclovir, amiodarone, atazanavir, caffeine, cimetidine, ciprofloxacin, enoxacin, famotidine, flutamide, fluvoxamine, lidocaine, lomefloxacin, mexiletine, moclobemide, norfloxacin, ofloxacin, perphenazine, propafenone, ropinirole, tacrine, ticlopidine, tocainide, verapamil
- CYP1A2 Inducers:
- Carbamazepine, esomeprazole, griseofulvin, lansoprazole, moricizine, omeprazole, rifampin, ritonavir
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-center, Randomized, Double-blind, Controlled Study Comparing the Efficacy and Safety of Pirfenidone Versus Placebo in the Treatment of Takayasu Arteritis on the Basis of Conventional Immunosuppressive Therapy
Takayasu arteritis is a severe vasculitis which could lead to significant disability and even death. While standard anti-inflammatory treatments can manage the systemic inflammation, they failed to stop a key driver of the disease: vascular fibrosis. This fibrosis could result in blood vessels thickening and narrowing, which continues to progress in many patients.
To tackle this critical treatment gap, the present project explores a new strategy. Building on pirfenidone's success in treating fibrosis in organs just like lungs and liver, along with promising early observations from our center, investigators believe adding this anti-fibrotic drug to standard therapy could improve vessel injury directly.
Therefore, investigators plan to conduct a clinical trial comparing pirfenidone with placebo in patients with Takayasu arteritis. The goal is to determine if this approach can successfully improve vascular injury and patient outcomes ultimately.
- Conditions
- Takayasu Arteritis
- Being tested
- Pirfenidone Capsules, Placebo
- Keywords
- fibrosis, pirfenidone, inflammation, Takayasu arteritis
- Medical subject headings
- Takayasu Arteritis, Fibrosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pirfenidone CapsulesDrug
pirfenidone 400mg.tid.po, escalated to 600mg.tid.po if acceptable in patients.
PlaceboDrug
Placebo capsules for pirfenidone.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| pirfenidone | Experimental | Not described Receives: Drug: Pirfenidone Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effectiveness of pirfenidone in the treatment of Takayasu arteritis compared to the placebo
Compared to placebo, the effectiveness of pirfenidone in the treatment of Takayasu arteritis is assessed with a composite endpoint. It indicates both clinical remission and imaging efficacy criterias must be met simultaneously, as follows:
Clinical remission should meet all of the following criterias (①-④):
- Absence of systemic symptoms such as fever, fatigue, or weight loss;
- No new vascular symptoms or signs, and no worsening of pre-existing vascular symptoms; ③ No new ischemic symptoms or signs, and no worsening of pre-existing ischemic symptoms; ④ Normal erythrocyte sedimentation rate (if abnormal, non-disease activity factors must be excluded; a repeat test should be performed for evaluation);
Note: If any of the following events occur in the CTCAE 5.0 grade increasing from baseline and reach grade 2 or higher, the case will be directly classified as not remission. These events include: ischemic stroke, syncope, intermittent claudication, and myocardial infarction.
Measured: "From enrollment to the end of treatment at 6 months"
Secondary outcomes (6)
The radiographic response rate of pirfenidone in the treatment of Takayasu arteritis at 6th month, compared to placebo.
- Imaging Effective: Vascular ultrasound or MRA confirms a ≥30% reduction in the thickness of the affected vessel wall compared to baseline, along with a ≥10% increase in vessel diameter.
- Imaging Improvement: Vascular ultrasound or MRA confirms a <30% reduction in the thickness of the affected vessel wall compared to baseline, along with a <10% expansion of the stenotic vessel diameter compared to baseline.
- Imaging Ineffective: Vascular ultrasound or MRA confirms any of the following: an increase in the thickness of the affected vessel wall compared to baseline, OR no expansion of the stenotic vessel diameter compared to baseline, OR the occurrence of an ischemic event.
Measured: From enrollment to the end of treatment at 6 months
Compared to placebo, the clinical remission rate of pirfenidone at the end of 6th month in the treatment of Takayasu arteritis.
Measured: From enrollment to the end of treatment at 6 months
Compared to placebo, the average dose of glucocorticoid at the end of 6th month in pirfenidone, in the treatment of Takayasu arteritis.
Measured: From enrollment to the end of treatment at 6 months
Compared to placebo, the incidence of ischemic events within 6 months for pirfenidone in the treatment of Takayasu arteritis.
Measured: From enrollment to the end of treatment at 6 months
Compared to placebo, changes of fibrosis markers (MMP-1, MMP-3, MMPP-9, TIMP-1, etc.) for pirfenidone in the treatment of Takayasu arteritis at the end of 6 months.
Measured: From enrollment to the end of treatment at 6 months
Compared to placebo， the improvement of quality of life at the end of month 6 with pirfenidone in the treatment of Takayasu arteritis (assessed by SF-36).
In the SF-36 scale, higher score indicates better outcome.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start20 Dec 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Takayasu ArteritisStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325357
- Sponsor's protocol ID
- TA-Fibrosis with PFD
- Status last verified
- Dec 2025
- First submitted
- 27 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma LY, Li CL, Chen RY, Dai XM, Ji ZF, Chen HY, Han H, Huang BJ, Sun Y, Jiang LD. The value of ultrasonography combined with clinical features for predicting carotid imaging progression of Takayasu's arteritis: a prospective cohort study. Clin Exp Rheumatol. 2021 Mar-Apr;39 Suppl 129(2):101-106. doi: 10.55563/clinexprheumatol/1o86of. Epub 2021 Mar 17.
PubMed 33734971Ma LY, Li CL, Ma LL, Cui XM, Dai XM, Sun Y, Chen HY, Huang BJ, Jiang LD. Value of contrast-enhanced ultrasonography of the carotid artery for evaluating disease activity in Takayasu arteritis. Arthritis Res Ther. 2019 Jan 16;21(1):24. doi: 10.1186/s13075-019-1813-2.
PubMed 30651132Lewis GA, Dodd S, Clayton D, Bedson E, Eccleson H, Schelbert EB, Naish JH, Jimenez BD, Williams SG, Cunnington C, Ahmed FZ, Cooper A, Rajavarma Viswesvaraiah, Russell S, McDonagh T, Williamson PR, Miller CA. Pirfenidone in heart failure with preserved ejection fraction: a randomized phase 2 trial. Nat Med. 2021 Aug;27(8):1477-1482. doi: 10.1038/s41591-021-01452-0. Epub 2021 Aug 12.
PubMed 34385704Munoz-Espinosa LE, Torre A, Cisneros L, Montalvo I, Male R, Mejia S, Aguilar JR, Lizardi J, Zuniga-Noriega J, Eugenia Icaza M, Gasca-Diaz F, Hernandez-Hernandez L, Cordero-Perez P, Chi L, Torres L, Rodriguez-Alvarez F, Tapia G, Poo JL. Noninvasive Evaluation of Prolonged-Release Pirfenidone in Compensated Liver Cirrhosis. ODISEA Study, a Randomised Trial. Liver Int. 2025 Jun;45(6):e70131. doi: 10.1111/liv.70131.
PubMed 40402087Noble PW, Albera C, Bradford WZ, Costabel U, Glassberg MK, Kardatzke D, King TE Jr, Lancaster L, Sahn SA, Szwarcberg J, Valeyre D, du Bois RM; CAPACITY Study Group. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011 May 21;377(9779):1760-9. doi: 10.1016/S0140-6736(11)60405-4. Epub 2011 May 13.
PubMed 21571362Shah PV, Balani P, Lopez AR, Nobleza CMN, Siddiqui M, Khan S. A Review of Pirfenidone as an Anti-Fibrotic in Idiopathic Pulmonary Fibrosis and Its Probable Role in Other Diseases. Cureus. 2021 Jan 4;13(1):e12482. doi: 10.7759/cureus.12482.
PubMed 33564498Kong X, Xu M, Cui X, Ma L, Cheng H, Hou J, Sun X, Ma L, Jiang L. Potential Role of Macrophage Phenotypes and CCL2 in the Pathogenesis of Takayasu Arteritis. Front Immunol. 2021 May 17;12:646516. doi: 10.3389/fimmu.2021.646516. eCollection 2021.
PubMed 34079541Rongyi C, Xiaojuan D, Jinghua W, Lingying M, Xiaomin D, Lili M, Huiyong C, Lindi J, Ying S. High level of serum complement 3 is a risk factor for vascular stenosis progression in TA patients receiving tocilizumab: a prospective observational study. Arthritis Res Ther. 2023 Aug 2;25(1):137. doi: 10.1186/s13075-023-03106-7.
PubMed 37533103Hellmich B, Agueda A, Monti S, Buttgereit F, de Boysson H, Brouwer E, Cassie R, Cid MC, Dasgupta B, Dejaco C, Hatemi G, Hollinger N, Mahr A, Mollan SP, Mukhtyar C, Ponte C, Salvarani C, Sivakumar R, Tian X, Tomasson G, Turesson C, Schmidt W, Villiger PM, Watts R, Young C, Luqmani RA. 2018 Update of the EULAR recommendations for the management of large vessel vasculitis. Ann Rheum Dis. 2020 Jan;79(1):19-30. doi: 10.1136/annrheumdis-2019-215672. Epub 2019 Jul 3.
PubMed 31270110Maz M, Chung SA, Abril A, Langford CA, Gorelik M, Guyatt G, Archer AM, Conn DL, Full KA, Grayson PC, Ibarra MF, Imundo LF, Kim S, Merkel PA, Rhee RL, Seo P, Stone JH, Sule S, Sundel RP, Vitobaldi OI, Warner A, Byram K, Dua AB, Husainat N, James KE, Kalot MA, Lin YC, Springer JM, Turgunbaev M, Villa-Forte A, Turner AS, Mustafa RA. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Giant Cell Arteritis and Takayasu Arteritis. Arthritis Rheumatol. 2021 Aug;73(8):1349-1365. doi: 10.1002/art.41774. Epub 2021 Jul 8.
PubMed 34235884Arnaud L, Haroche J, Mathian A, Gorochov G, Amoura Z. Pathogenesis of Takayasu's arteritis: a 2011 update. Autoimmun Rev. 2011 Nov;11(1):61-7. doi: 10.1016/j.autrev.2011.08.001. Epub 2011 Aug 9.
PubMed 21855656Park SJ, Kim HJ, Park H, Hann HJ, Kim KH, Han S, Kim Y, Ahn HS. Incidence, prevalence, mortality and causes of death in Takayasu Arteritis in Korea - A nationwide, population-based study. Int J Cardiol. 2017 May 15;235:100-104. doi: 10.1016/j.ijcard.2017.02.086. Epub 2017 Feb 22.
PubMed 28283361Wen D, Du X, Ma CS. Takayasu arteritis: diagnosis, treatment and prognosis. Int Rev Immunol. 2012 Dec;31(6):462-73. doi: 10.3109/08830185.2012.740105.
PubMed 23215768
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Double-blind, Controlled Study Comparing the Efficacy and Safety of Pirfenidone Versus Placebo in the Treatment of Takayasu Arteritis on the Basis of Conventional Immunosuppressive Therapy
- ClinicalTrials.gov ID
- NCT07325357
- Acronym / sponsor ID
- TA-Fibrosis with PFD
- Conditions
- Takayasu Arteritis
- Keywords
- fibrosis, pirfenidone, inflammation, Takayasu arteritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Jan 2026 (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.
Takayasu arteritis is a severe vasculitis which could lead to significant disability and even death. While standard anti-inflammatory treatments can manage the systemic inflammation, they failed to stop a key driver of the disease: vascular fibrosis. This fibrosis could result in blood vessels thickening and narrowing, which continues to progress in many patients.
To tackle this critical treatment gap, the present project explores a new strategy. Building on pirfenidone's success in treating fibrosis in organs just like lungs and liver, along with promising early observations from our center, investigators believe adding this anti-fibrotic drug to standard therapy could improve vessel injury directly.
Therefore, investigators plan to conduct a clinical trial comparing pirfenidone with placebo in patients with Takayasu arteritis. The goal is to determine if this approach can successfully improve vascular injury and patient outcomes ultimately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo |
| pirfenidone | Experimental | Drug: Pirfenidone Capsules |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (27 listed)
- Patients who have signed the informed consents and meet the ACR 2022 classification criteria for Takayasu arteritis.
- Male or female, age between 18 and 60 years.
- Female patients must have a negative serum or urine pregnancy test and do not have pregnancy plans during the study period.
- Within the 3 months prior to enrollment, the patient's treatment regimen must consist of glucocorticoids and immunosuppressants (methotrexate). Biological agents (IL-6R, TNF, or monoclonal antibody) might be used based on clinical need. Other targeted therapies (such as CD20 monoclonal antibodies, JAK inhibitors, etc.) or cell-based therapies (such as CAR-T or stem cell therapy) are not permitted.
- During the 6-month follow-up period, the dosage and frequency of existing methotrexate and biologics (IL-6R monoclonal antibody, TNF monoclonal antibody, IL17 monoclonal antibody) must remain unchanged, except for adjustments of glucocorticoid doses based on clinical condition.
Key exclusion criteria (12 listed)
- Presence of autoimmune diseases or autoinflammatory diseases other than Takayasu arteritis (e.g., systemic lupus erythematosus, ankylosing spondylitis, rheumatoid arthritis, etc.);
- Use of antifibrotic drugs or drugs with potential antifibrotic properties (such as acetylcysteine, nintedanib, pirfenidone, etc.) within 6 months prior to enrollment, or participation in other clinical trials involving antifibrotic therapies;
- Impaired liver function (elevated transaminases ALT/AST >2 times the upper limit of normal, or bilirubin exceeding the upper limit of normal), severe renal insufficiency (eGFR <15 mL/min/1.73m²), or requirement for psychotropic medications (excluding sleep medicine for sleep disorders);
- Any severe, progressive, or uncontrolled concurrent hematological, gastrointestinal, pulmonary, cardiac, neurological, or other medical conditions unrelated to Takayasu arteritis which could pose unpredictable risks, in the investigator's judgment;
- Allergy to the investigational drug or previous failure of regular pirfenidone treatment for 3 months;
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 |
|---|---|---|
| Pirfenidone Capsulespirfenidone 400mg.tid.po, escalated to 600mg.tid.po if acceptable in patients. | Drug | pirfenidone |
| PlaceboPlacebo capsules for pirfenidone. | Drug | placebo |
Primary outcome
the effectiveness of pirfenidone in the treatment of Takayasu arteritis compared to the placebo
Time frame: "From enrollment to the end of treatment at 6 months"
Compared to placebo, the effectiveness of pirfenidone in the treatment of Takayasu arteritis is assessed with a composite endpoint. It indicates both clinical remission and imaging efficacy criterias must be met simultaneously, as follows: Clinical remission should meet all of the following criterias (①-④): * Absence of systemic symptoms such as fever, fatigue, or weight loss; * No new vascular symptoms or signs, and no worsening of pre-existing vascular symptoms; ③ No new ischemic symptoms or signs, and no worsening of pre-existing ischemic symptoms; ④ Normal erythrocyte sedimentation rate (if abnormal, non-disease activity factors must be excluded; a repeat test should be performed for evaluation); Note: If any of the following events occur in the CTCAE 5.0 grade increasing from baseline and reach grade 2 or higher, the case will be directly classified as not remission. These events include: ischemic stroke, syncope, intermittent claudication, and myocardial infarction.
6 secondary outcomes
The radiographic response rate of pirfenidone in the treatment of Takayasu arteritis at 6th month, compared to placebo.
Time frame: From enrollment to the end of treatment at 6 months
Compared to placebo, the clinical remission rate of pirfenidone at the end of 6th month in the treatment of Takayasu arteritis.
Time frame: From enrollment to the end of treatment at 6 months
Compared to placebo, the average dose of glucocorticoid at the end of 6th month in pirfenidone, in the treatment of Takayasu arteritis.
Time frame: From enrollment to the end of treatment at 6 months
Compared to placebo, the incidence of ischemic events within 6 months for pirfenidone in the treatment of Takayasu arteritis.
Time frame: From enrollment to the end of treatment at 6 months
Compared to placebo, changes of fibrosis markers (MMP-1, MMP-3, MMPP-9, TIMP-1, etc.) for pirfenidone in the treatment of Takayasu arteritis at the end of 6 months.
Time frame: From enrollment to the end of treatment at 6 months
Compared to placebo， the improvement of quality of life at the end of month 6 with pirfenidone in the treatment of Takayasu arteritis (assessed by SF-36).
Time frame: From enrollment to the end of treatment at 6 months
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 8 Jan 2026.
- Background: PubMed 33734971Ma LY, Li CL, Chen RY, Dai XM, Ji ZF, Chen HY, Han H, Huang BJ, Sun Y, Jiang LD. The value of ultrasonography combined with clinical features for predicting carotid imaging progression of Takayasu's arteritis: a prospective cohort study. Clin Exp Rheumatol. 2021 Mar-Apr;39 Suppl 129(2):101-106. doi: 10.55563/clinexprheumatol/1o86of. Epub 2021 Mar 17.
- Background: PubMed 30651132Ma LY, Li CL, Ma LL, Cui XM, Dai XM, Sun Y, Chen HY, Huang BJ, Jiang LD. Value of contrast-enhanced ultrasonography of the carotid artery for evaluating disease activity in Takayasu arteritis. Arthritis Res Ther. 2019 Jan 16;21(1):24. doi: 10.1186/s13075-019-1813-2.
- Background: PubMed 34385704Lewis GA, Dodd S, Clayton D, Bedson E, Eccleson H, Schelbert EB, Naish JH, Jimenez BD, Williams SG, Cunnington C, Ahmed FZ, Cooper A, Rajavarma Viswesvaraiah, Russell S, McDonagh T, Williamson PR, Miller CA. Pirfenidone in heart failure with preserved ejection fraction: a randomized phase 2 trial. Nat Med. 2021 Aug;27(8):1477-1482. doi: 10.1038/s41591-021-01452-0. Epub 2021 Aug 12.
- Background: PubMed 40402087Munoz-Espinosa LE, Torre A, Cisneros L, Montalvo I, Male R, Mejia S, Aguilar JR, Lizardi J, Zuniga-Noriega J, Eugenia Icaza M, Gasca-Diaz F, Hernandez-Hernandez L, Cordero-Perez P, Chi L, Torres L, Rodriguez-Alvarez F, Tapia G, Poo JL. Noninvasive Evaluation of Prolonged-Release Pirfenidone in Compensated Liver Cirrhosis. ODISEA Study, a Randomised Trial. Liver Int. 2025 Jun;45(6):e70131. doi: 10.1111/liv.70131.
- Background: PubMed 21571362Noble PW, Albera C, Bradford WZ, Costabel U, Glassberg MK, Kardatzke D, King TE Jr, Lancaster L, Sahn SA, Szwarcberg J, Valeyre D, du Bois RM; CAPACITY Study Group. Pirfenidone in patients with idiopathic pulmonary fibrosis (CAPACITY): two randomised trials. Lancet. 2011 May 21;377(9779):1760-9. doi: 10.1016/S0140-6736(11)60405-4. Epub 2011 May 13.
- Background: PubMed 33564498Shah PV, Balani P, Lopez AR, Nobleza CMN, Siddiqui M, Khan S. A Review of Pirfenidone as an Anti-Fibrotic in Idiopathic Pulmonary Fibrosis and Its Probable Role in Other Diseases. Cureus. 2021 Jan 4;13(1):e12482. doi: 10.7759/cureus.12482.
- Background: PubMed 34079541Kong X, Xu M, Cui X, Ma L, Cheng H, Hou J, Sun X, Ma L, Jiang L. Potential Role of Macrophage Phenotypes and CCL2 in the Pathogenesis of Takayasu Arteritis. Front Immunol. 2021 May 17;12:646516. doi: 10.3389/fimmu.2021.646516. eCollection 2021.
- Background: PubMed 37533103Rongyi C, Xiaojuan D, Jinghua W, Lingying M, Xiaomin D, Lili M, Huiyong C, Lindi J, Ying S. High level of serum complement 3 is a risk factor for vascular stenosis progression in TA patients receiving tocilizumab: a prospective observational study. Arthritis Res Ther. 2023 Aug 2;25(1):137. doi: 10.1186/s13075-023-03106-7.
- Background: PubMed 31270110Hellmich B, Agueda A, Monti S, Buttgereit F, de Boysson H, Brouwer E, Cassie R, Cid MC, Dasgupta B, Dejaco C, Hatemi G, Hollinger N, Mahr A, Mollan SP, Mukhtyar C, Ponte C, Salvarani C, Sivakumar R, Tian X, Tomasson G, Turesson C, Schmidt W, Villiger PM, Watts R, Young C, Luqmani RA. 2018 Update of the EULAR recommendations for the management of large vessel vasculitis. Ann Rheum Dis. 2020 Jan;79(1):19-30. doi: 10.1136/annrheumdis-2019-215672. Epub 2019 Jul 3.
- Background: PubMed 34235884Maz M, Chung SA, Abril A, Langford CA, Gorelik M, Guyatt G, Archer AM, Conn DL, Full KA, Grayson PC, Ibarra MF, Imundo LF, Kim S, Merkel PA, Rhee RL, Seo P, Stone JH, Sule S, Sundel RP, Vitobaldi OI, Warner A, Byram K, Dua AB, Husainat N, James KE, Kalot MA, Lin YC, Springer JM, Turgunbaev M, Villa-Forte A, Turner AS, Mustafa RA. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Giant Cell Arteritis and Takayasu Arteritis. Arthritis Rheumatol. 2021 Aug;73(8):1349-1365. doi: 10.1002/art.41774. Epub 2021 Jul 8.
- Background: PubMed 21855656Arnaud L, Haroche J, Mathian A, Gorochov G, Amoura Z. Pathogenesis of Takayasu's arteritis: a 2011 update. Autoimmun Rev. 2011 Nov;11(1):61-7. doi: 10.1016/j.autrev.2011.08.001. Epub 2011 Aug 9.
- Background: PubMed 28283361Park SJ, Kim HJ, Park H, Hann HJ, Kim KH, Han S, Kim Y, Ahn HS. Incidence, prevalence, mortality and causes of death in Takayasu Arteritis in Korea - A nationwide, population-based study. Int J Cardiol. 2017 May 15;235:100-104. doi: 10.1016/j.ijcard.2017.02.086. Epub 2017 Feb 22.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pirfenidone Capsules in people with Takayasu Arteritis, run by Shanghai Zhongshan Hospital.
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 27 inclusion and 12 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: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Rongyi Chen, Dr. (02164041990, chenry825@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effectiveness of pirfenidone in the treatment of Takayasu arteritis compared to the placebo (time frame: "From enrollment to the end of treatment at 6 months"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07325357, which also lists 13 linked publications.
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 8 Jan 2026.