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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline/3months/6months |
| Change From Baseline Levels in Serum Immunoglobulin A (IgA) Levels in Serum Immunoglobulin G (IgG) Levels in Serum Immunoglobulin M (IgM) |
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Inclusion Criteria:
Exclusion Criteria:
• Secondary IgA nephropathy such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B-associated nephritis, etc.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
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Single center, Open Label, Comparative study
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|
|
| Corticosteroid | Drug | Standard Supportive Care plus Corticosteroid(≤1mg/kg/d) without immunosuppressants |
|
|
| 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 |
|
|
The change in serum levels of IgA/IgG/IgM from baseline was reported. |
| Baseline/ 3months/6months |
| Change From Baseline in Serum Complement C3 and C4 Levels | The change in serum component C3 and C4 from baseline were reported. | Baseline/3months/6months |
| 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. | Baseline/3months/6months |
| 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. | Baseline/3months/6months |
| 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:
| Baseline/3months/6months |
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000722462 | telitacicept |
| D000305 | Adrenal Cortex Hormones |
| D011239 | Prednisolone |
| D008775 | Methylprednisolone |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D057911 | Angiotensin Receptor Antagonists |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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