Efficacy and Safety of Telitacicept in IgAN
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRuijin Hospital
About this trial
A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-70 years old, male or female
Primary IgA nephropathy confirmed by renal biopsy.
Urine protein ≥ 0.75g/24h or 24-hour urine protein creatinine ratio (PCR) ≥ 0.6 g/g.
eGFR ≥ 25 ml/min/1.73 m2 calculated using the CKD-EPI formula.
Disqualifiers
Patients with abnormal laboratory indicators (see study protocol for details).
Secondary IgA nephropathy such as Henoch-Schonlein purpura, SLE, cirrhosis, etc.
Use of systemic glucocorticoids/immunosuppressants within 3 months (such as cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.).
Use of biological agents within 6 months (rituximab, etc.).
Trial design
Design model
Parallel
Treatments tested in this trial
Telitacicept 240mg
DrugPatients in telitacicept group will be treated with maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and/or angiotensin II receptor blocker ( ARB ) combined with telitacicept. 240 mg telitacicept will be used once a week for 40 weeks.
Glucocorticoid
DrugPatients in glucocorticoid group will be treated with ACEI/ARB and glucocorticoid ( prednisone/prednisolone) 0.5mg/kg (maximum 40mg/d). After 8 weeks, reduce the dosage by 5 mg per month for a total of 28-40 weeks.
Treatment groups
118 Participants
are divided into 2 treatment groupsGroup A: Telitacicept+ACEI/ARBExperimental treatment 1 intervention
Group B: Glucocorticoids+ACEI/ARBActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change of 24-hour urine protein
Change of 24-hour urine protein from baseline to week 40
Time frame
From baseline to week 40Secondary outcomes
1
Change of PCR
Change of 24-hour urine protein creatinine ratio (PCR) from baseline to week 40
Time frame
From baseline to week 402
Annualized eGFR slope
Annualized eGFR slope from baseline to week 40
Time frame
From baseline to week 403
Change of eGFR
Change of eGFR from baseline to week 40
Time frame
From baseline to week 404
Proportion of patients with a decrease in eGFR ≥30%
Proportion of patients with a decrease in eGFR ≥30% from baseline to week 40
Time frame
From baseline to week 40Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ruijin Hospital
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
RenJi Hospital
Collaborator
Sichuan Provincial People's Hospital
Collaborator
Renmin Hospital of Wuhan University
Collaborator
Shanghai 6th People's Hospital
Collaborator
Shanghai Longhua Hospital
Collaborator
Huashan Hospital
Collaborator
Shanghai Changzheng Hospital
Collaborator
Wannan Medical College Yijishan Hospital
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Collaborator
Source ClinicalTrials.gov