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IgA Nephropathy (IgAN)Phase 3NCT07098897

To Evaluate the Effect and Safety of Telitacicept and Standard Treatment for 6months in IgA Nephropathy

A Phase 3 study testing Telitacicept 160mg, Corticosteroid and ACE Inhibitor or Angiotensin receptor antagonist in people with IgA Nephropathy (IgAN), run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Telitacicept in patients with IgA nephropathy. The control group will be observed for up to 6months without administration of Telitacicept. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
IgA Nephropathy (IgAN)
What is being tested?
Telitacicept 160mg, Corticosteroid and ACE Inhibitor or Angiotensin receptor antagonist
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
1 Aug 2024to 30 Sep 2025
Phase
Phase 3
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18~75 years, regardless of gender.
  • Clinical evaluation and renal biopsy diagnostic for IgA nephropathy.
  • Average urinary protein excretion of 0.3~3.5g/24h on two successive examinations.
  • Urine Protein to Creatinine Ratio (UPCR) >= 0.75 and <= 6 milligram per milligram (mg/mg) during screening.
  • Stable and optimal dose of Angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blockers (ARB) at least 8 weeks prior to screening.
  • eGFR≥30 ml/min/1.73m2.
  • Willingness to sign an informed consent.

Who cannot join

  • • Secondary IgA nephropathy such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B-associated nephritis, etc.
  • IgA nephropathy with significant glomerulosclerosis or cortical scarring.
  • Failure to meet estimated glomerular filtration rate (eGFR) and biopsy requirement criteria.
  • Rapidly progressive nephritic syndrome.
  • Acute renal failure, including rapidly progressive IgA nephropathy.
  • Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
Show all 18Show fewer
  • Cirrhosis, chronic active liver disease, and serious liver function damage.
  • History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease).
  • Any Active systemic infection or history of serious infection within one month.
  • Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure, chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases).
  • Active tuberculosis or untreated latent TB infection.
  • Malignant hypertension that is difficult to be controlled by oral drugs.
  • Known allergy, contraindication, or intolerance to the steroids.
  • Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception.
  • Malignant tumors.
  • Excessive drinking or drug abuse.
  • Mental aberrations.
  • Any condition, including any uncontrolled disease state other than IgA nephropathy.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

Other trials in China

About this study

Official title: To Evaluate the Effect and Safety of Telitacicept and Standard Treatment for 6months in IgA Nephropathy, Single Center, Randomized, Open Label, Comparative Study

The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Telitacicept in patients with IgA nephropathy. The control group will be observed for up to 6months without administration of Telitacicept.

This Single center, Randomized, Open Label, Comparative study will evaluate the effect and safety of and Standard treatment for 6months in IgA Nephropathy.

Read the detailed description

IgA nephropathy is the most common primary glomerulonephritis worldwide. Immune complexes, composed of galactose-deficient IgA1 and Gd-IgA1 autoantibodies, are deposited in the mesangial area of the glomeruli where they induce complement-mediated inflammation. This may result in the reduced kidney function, which can progress to end-stage kidney disease. Treatment options are very limited. It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR>50ml/min/1.73m2 in IgA nephropathy, the KDIGO guidelines suggest a 6-month course of glucocorticoids. Many studies further showed that 6-month course of glucocorticoids with higher side effects and leading to discontinue of glucocorticoids course before the beneficial effect of 6months course. Currently monoclonal antibodies, that may affect the main axis of pathogenesis of IgA nephropathy and biological therapy such as Telitacicept, provides a new treatment option and altering or depletion or modulation of Gd-IgA1 producing B cells and plasma cells. At present, Telitacicept are used for clinical treatment in IgA nephropathy patient inside China, but still clear data on safety and effect, and patient's complete remission, repeated relapse data are unclear. This study is a Single center, Randomized, Open Label, Comparative study. In the study, around 60-100 patients with IgA nephropathy will be enrolled, and they will be treated with Telitacicept for 6 months on the basis of conventional treatment.

Being tested
Telitacicept 160mg, Corticosteroid, ACE Inhibitor or Angiotensin receptor antagonist
Keywords
Telitacicept, glomerulonephritis, iga, B-cell activating factor BAFF, a proliferation-inducing ligand APRIL, IgA Nephropathy
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telitacicept 160mgDrug

    Also called Low Dosage Corticosteroid

    Currently monoclonal antibodies, that may affect the main axis of pathogenesis of IgA nephropathy and biological therapy such as Telitacicept, provides a new treatment option and altering or depletion or modulation of Gd-IgA1 producing B cells and plasma cells. At present, Telitacicept are used for clinical treatment in IgA nephropathy patient inside China, but still clear data on safety and effect, and patient's complete remission, repeated relapse data are unclear.

  • CorticosteroidDrug

    Also called Prednisolone, Methylprednisolone

    Standard Supportive Care plus Corticosteroid(≤1mg/kg/d) without immunosuppressants

  • ACE Inhibitor or Angiotensin receptor antagonistDrug

    Also called ACE inhibitors, ARB inhibitors

    Drug: ACE Inhibitor (Treatment for proteinuria suppression and blood pressure regulation) - 2-3months before randomization Drug: ARB Inhibitor (Treatment for proteinuria suppression and blood pressure regulation) - 2-3months before randomization

Study groups in NCT07098897
Study groupRoleWhat they receive
Target Therapy Group(TTG)ExperimentalStandard Supportive Care plus Telitacicept injected Subcutaneously 160mg/time, once a week for a total of 24 weeks Target based Drug: Telitacicept 160mg once a week for 24 weeks Other Name: RC18 Drug: Standard Supportive Care plus Low dosage of Corticosteroid(≤0.5mg/kg/d) without immunosuppressants Other Name: Prednisolone / Methylprednisolone
Receives: Drug: Telitacicept 160mg
Corticosteroid Therapy Group (CTG)Active comparatorStandard Supportive Care plus Corticosteroid Drug: Standard Supportive Care plus Corticosteroid(≤1mg/kg/d) without immunosuppressants Other Name: Prednisolone / Methylprednisolone
Receives: Drug: Corticosteroid
Supportive Care Group (SCG)Active comparatorStandard Supportive Care Drug: ACE Inhibitor (Treatment for proteinuria suppression and blood pressure regulation) - 2-3months before randomization Drug: ARB Inhibitor (Treatment for proteinuria suppression and blood pressure regulation) - 2-3months before randomization
Receives: Drug: ACE Inhibitor or Angiotensin receptor antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete remission of proteinuria

    Proteinuria<0.3g/24h

    Measured: Baseline/3months/6months

  2. Partial remission of proteinuria

    Proteinuria decline>50%

    Measured: Baseline/3months/6months

  3. Change from baseline to 6months in 24 Hours Urine Protein in g/24hrs

    Compare the Baseline 24 Hours Urine Protein to 6month

    Measured: Baseline/3months/6months

  4. Change from baseline to 6months in eGFR

    Compare the baseline eGFR to 6months

    Measured: Baseline/3months/6months

Secondary outcomes (6)

  1. Deterioration of renal function

    The longitudinal decline of eGFR, serum creatinine arises>50%, or eGFR decline>25%, or onset of end-stage renal disease or dialysis treatment.

    Measured: Baseline/3months/6months

  2. Change From Baseline Levels in Serum Immunoglobulin A (IgA) Levels in Serum Immunoglobulin G (IgG) Levels in Serum Immunoglobulin M (IgM)

    The change in serum levels of IgA/IgG/IgM from baseline was reported.

    Measured: Baseline/ 3months/6months

  3. Change From Baseline in Serum Complement C3 and C4 Levels

    The change in serum component C3 and C4 from baseline were reported.

    Measured: Baseline/3months/6months

  4. Percentage of Participants With Clinical Significant Abnormalities in Laboratory Assessments, including Blood Pressure

    Laboratory investigation included haematology, biochemistry, urinalysis and Urine sediment analysis. Clinical significance was to be decided by the investigator. The systolic and diastolic blood pressure was measured after the participants have in a rested at least 3 minutes in seated position. Clinical significance was to be decided by the investigator.

    Measured: Baseline/3months/6months

  5. Number of Participants With a Treatment-emergent Adverse Event (TEAE)

    An Adverse event (AE) was any untoward medical occurrence in a clinical study participant. TEAEs were defined, within a dosing group, as AEs that started on or after the first dose of study treatment through 30 days after the last dose of study drug.

    Measured: Baseline/3months/6months

  6. Number of Participants Who Experienced a Serious Adverse Event (SAE)

    A serious adverse event (SAE) was an adverse event/reaction that results in any of the following outcomes:

    • Death
    • Is life-threatening (participant was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe)
    • Requires participant hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization
    • Results in persistent or significant disability/incapacity (ie, there was a substantial disruption of a person's ability to carry out normal life functions)
    • Is a congenital anomaly/birth defect

    Measured: Baseline/3months/6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2025
  2. Study start1 Aug 2024
  3. Primary completion25 May 2025
  4. Study completion30 Sep 2025 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Single center, Open Label, Comparative study
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07098897
Sponsor's protocol ID
XYFY2024-KL281-01
Status last verified
Jul 2025
First submitted
23 Jul 2025
Last updated
1 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telitacicept 160mg, Corticosteroid and ACE Inhibitor or Angiotensin receptor antagonist in people with IgA Nephropathy (IgAN), run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.

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 18 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: under way, not looking for participants, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete remission of proteinuria (time frame: Baseline/3months/6months). The study lists 4 primary outcomes in all. 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 NCT07098897.

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 1 Aug 2025.

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