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

NCT07098897 | Active Not Recruiting Phase 3

• 1 other identifier: XYFY2024-KL281-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

IgA Nephropathy (IgAN)

Keywords

Telitacicept; glomerulonephritis, iga; B-cell activating factor BAFF; a proliferation-inducing ligand APRIL; IgA Nephropathy

Outcome Measures

Primary Outcomes (4)

• Complete remission of proteinuria

  Proteinuria\<0.3g/24h

  Baseline/3months/6months

• Partial remission of proteinuria

  Proteinuria decline\>50%

  Baseline/3months/6months

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

  Compare the Baseline 24 Hours Urine Protein to 6month

  Baseline/3months/6months

• Change from baseline to 6months in eGFR

  Compare the baseline eGFR to 6months

  Baseline/3months/6months

Secondary Outcomes (6)

• Deterioration of renal function

  Baseline/3months/6months

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

  Baseline/ 3months/6months

• Change From Baseline in Serum Complement C3 and C4 Levels

  Baseline/3months/6months

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

  Baseline/3months/6months

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

  Baseline/3months/6months

Study Arms (3)

Target Therapy Group(TTG)

EXPERIMENTAL

Standard 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

Drug: Telitacicept 160mg

Corticosteroid Therapy Group (CTG)

ACTIVE COMPARATOR

Standard Supportive Care plus Corticosteroid Drug: Standard Supportive Care plus Corticosteroid(≤1mg/kg/d) without immunosuppressants Other Name: Prednisolone / Methylprednisolone

Drug: Corticosteroid

Supportive Care Group (SCG)

ACTIVE COMPARATOR

Standard 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

Drug: ACE Inhibitor or Angiotensin receptor antagonist

Interventions

Telitacicept 160mg DRUG

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.

Also known as: Low Dosage Corticosteroid

Target Therapy Group(TTG)

Corticosteroid DRUG

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

Also known as: Prednisolone, Methylprednisolone

Corticosteroid Therapy Group (CTG)

ACE Inhibitor or Angiotensin receptor antagonist DRUG

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

Also known as: ACE inhibitors, ARB inhibitors

Supportive Care Group (SCG)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The First Affiliated hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

telitacicept; Adrenal Cortex Hormones; Prednisolone; Methylprednisolone; Angiotensin-Converting Enzyme Inhibitors; Angiotensin Receptor Antagonists

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Nephrology Department

Model Details: Single center, Open Label, Comparative study

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 1, 2025
• Study Start: August 1, 2024
• Primary Completion: May 25, 2025
• Study Completion: September 30, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CN (1)