Back to resultsStudy of Telitacicept in Patients With Refractory IgA Nephropathy
Primary Purpose
IgA Nephropathy
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Telitacicept
Sponsored by
About this trial
This is an interventional treatment trial for IgA Nephropathy
Eligibility Criteria
Inclusion Criteria:
- Voluntarily sign the informed consent form.
- IgA nephropathy was confirmed by pathological biopsy.
- Age range: ≥ 18 years old, ≤ 70 years old, male or female.
- During the screening period, the 24-hour urine protein of Visit 1 and Visit 2 should meet at least one ≥0.75g/24h, and the 24-hour urine protein ≥ 0.75g/24h at Visit 3.
- Measured glomerular filtration rate or estimated GFR (using the CKD-EPI formula) > 35 mL/min/1.73 m2.
- Participants had received a basic regimen including ACE inhibitors/ARBs for 12 weeks prior to randomization, and the dose of ACE inhibitors/ARBs (within the maximum tolerated range) was stable for 4 weeks prior to randomization.
Exclusion Criteria:
- Abnormal laboratory indicators of participants need to be excluded.
- Secondary IgA nephropathy need to be excluded.
- Specific pathologic or clinical renal disease types, and IgA nephropathy that may require hormone therapy.
- Patients who have experienced any of the following cardiovascular and cerebrovascular events within the 12 weeks prior to screening.
- Use of systemic corticosteroids within 3 months prior to randomization (except local, nasal inhalation, etc.)
- Immunosuppressants were used within 3 months prior to randomization.
- Patients requiring hospitalization for active infection or intravenous anti-infective therapy within 3 months prior to randomization.
- Previously or currently diagnosed active tuberculosis Untreated latent tuberculosis.
- Herpes zoster HIV antibody positive or HCV antibody positive during the screening period.
- Those who currently have active hepatitis or have severe liver disease and medical history.
- Patients with malignant tumors.
- Pregnant and lactating women, and men or women with planned children during the trial period.
- Those who could not avoid the use of nephrotoxic drugs during the trial.
- Allergic to human biological products.
- Patients who have been given any of the clinical trial drugs 4 weeks prior to randomization or within 5 times the half-life of the experimental drug (whichever is longer).
- Patients deemed ineligible for the trial by the investigator.
Sites / Locations
- The Second Affiliated Hospital of Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telitacicept treated group
Arm Description
Outcomes
Primary Outcome Measures
Complete clinical response
a. Proteinuria: protein-to-creatinine ratio <0.2; b. Stable renal function: eGFR decreased by less than 5ml/min/1.73m2 from baseline at the end of the 3-year trial phase.
The absolute value of eGFR
The absolute value of eGFR decreased by more than 15 ml/min/1.73m2 over 3 years from baseline
Changes in 24-hour urinary protein
Changes in 24-hour urinary protein at week 104 compared with baseline.
Secondary Outcome Measures
eGFR decrease
The estimated glomerular filtration rate (eGFR) decreased by more than 30 ml/min/1.73 m2 from baseline.
Need for dialysis
progression to end-stage renal disease
Full Information
NCT ID
NCT05596708
First Posted
October 25, 2022
Last Updated
February 22, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05596708
Brief Title
Study of Telitacicept in Patients With Refractory IgA Nephropathy
Official Title
A Single-arm, Forward-looking, Exploratory Clinical Study of Telitacicept in Patients With Refractory IgA Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy.
The main questions it aims to answer are:
To evaluate the clinical efficacy of Telitacicept in patients with refractory IgA nephropathy.
To evaluate the safety and adverse reaction of Telitacicept in patients with refractory IgA nephropathy.
Participants will be subcutaneously injected with 240mg of Telitacicept once per week.
Study subject: After 6 months of sequential treatment with renin-angiotensin system (RAS) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory IgA nephropathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telitacicept treated group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Telitacicept
Intervention Description
Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for 104 weeks.
Primary Outcome Measure Information:
Title
Complete clinical response
Description
a. Proteinuria: protein-to-creatinine ratio <0.2; b. Stable renal function: eGFR decreased by less than 5ml/min/1.73m2 from baseline at the end of the 3-year trial phase.
Time Frame
3-year
Title
The absolute value of eGFR
Description
The absolute value of eGFR decreased by more than 15 ml/min/1.73m2 over 3 years from baseline
Time Frame
3-year
Title
Changes in 24-hour urinary protein
Description
Changes in 24-hour urinary protein at week 104 compared with baseline.
Time Frame
104 weeks
Secondary Outcome Measure Information:
Title
eGFR decrease
Description
The estimated glomerular filtration rate (eGFR) decreased by more than 30 ml/min/1.73 m2 from baseline.
Time Frame
3-year
Title
Need for dialysis
Description
progression to end-stage renal disease
Time Frame
3-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntarily sign the informed consent form.
IgA nephropathy was confirmed by pathological biopsy.
Age range: ≥ 18 years old, ≤ 70 years old, male or female.
During the screening period, the 24-hour urine protein of Visit 1 and Visit 2 should meet at least one ≥0.75g/24h, and the 24-hour urine protein ≥ 0.75g/24h at Visit 3.
Measured glomerular filtration rate or estimated GFR (using the CKD-EPI formula) > 35 mL/min/1.73 m2.
Participants had received a basic regimen including ACE inhibitors/ARBs for 12 weeks prior to randomization, and the dose of ACE inhibitors/ARBs (within the maximum tolerated range) was stable for 4 weeks prior to randomization.
Exclusion Criteria:
Abnormal laboratory indicators of participants need to be excluded.
Secondary IgA nephropathy need to be excluded.
Specific pathologic or clinical renal disease types, and IgA nephropathy that may require hormone therapy.
Patients who have experienced any of the following cardiovascular and cerebrovascular events within the 12 weeks prior to screening.
Use of systemic corticosteroids within 3 months prior to randomization (except local, nasal inhalation, etc.)
Immunosuppressants were used within 3 months prior to randomization.
Patients requiring hospitalization for active infection or intravenous anti-infective therapy within 3 months prior to randomization.
Previously or currently diagnosed active tuberculosis Untreated latent tuberculosis.
Herpes zoster HIV antibody positive or HCV antibody positive during the screening period.
Those who currently have active hepatitis or have severe liver disease and medical history.
Patients with malignant tumors.
Pregnant and lactating women, and men or women with planned children during the trial period.
Those who could not avoid the use of nephrotoxic drugs during the trial.
Allergic to human biological products.
Patients who have been given any of the clinical trial drugs 4 weeks prior to randomization or within 5 times the half-life of the experimental drug (whichever is longer).
Patients deemed ineligible for the trial by the investigator.
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Kunling, PhD
Phone
15150515798
Email
klma@zju.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study of Telitacicept in Patients With Refractory IgA Nephropathy
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